[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"esophageal-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:esophageal-squamous-cell-carcinoma":32},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,112,0,25,[9,52,94,114,147,174,199,223,277,312,341,389,418,438,457,480,499,519,541,563,600,628,653,687,716],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100601379","phase-1-a-phase-12-trial-of-ter-2013-in-patients-with-solid-tumors-harboring-aktpi3kpten-pathway-alterations-100601379",false,"NCT07109726","A Phase 1\u002F2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT\u002FPI3K\u002FPTEN Pathway Alterations","Key Inclusion Criteria\n\n* Metastatic or locally advanced, unresectable disease\n* No available treatment with curative intent\n* Presence of lesions to be evaluated per RECIST v1.1:\n\n  a. Dose Escalation: measurable or evaluable disease b. Cohort Expansion: measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate organ function\n* Advanced solid tumor malignancy harboring an eligible AKT\u002FPI3K\u002FPTEN pathway alteration detected by a sponsor approved test\n\nKey Inclusion Criteria for TER-2013 monotherapy arms:\n\n* Histologically confirmed diagnosis of:\n\n  a. \\[For TER-2013 dose escalation\\]: solid tumor malignancy b. \\[For TER-2013 cohort expansion\\]: i. Cohort 1: ovarian cancer, cervical cancer, or squamous cell carcinoma of the head and neck, lung, or esophagus ii. Cohort 2: endometrial adenocarcinoma\n* Prior therapy:\n\n  1. \\[For TER-2013 dose escalation\\]: Received standard therapies appropriate for their tumor type and stage, unless contraindicated, intolerable, or patient refused\n  2. \\[For TER-2013 cohort expansion\\]: No more than 3 prior lines of treatment in the advanced setting\n\n     Key Inclusion Criteria for TER-2013 and fulvestrant combination arms\n* Histologically confirmed diagnosis of:\n\n  a. \\[For TER-2013 + fulvestrant dose escalation\\]: HR+\u002FHER2- advanced unresectable or metastatic breast cancer b. \\[For TER-2013 + fulvestrant cohort expansion\\]: i. Received treatment with an AI containing regimen (single agent or in combination) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting\n* Prior Therapy:\n\n  a. \\[For TER-2013 + fulvestrant dose escalation\\]: Received treatment with an AI containing regimen (single agent or in combination) b. \\[For TER-2013 + fulvestrant cohort expansion\\]: i. Received treatment with an AI containing regimen (single agent or in combination) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting\n\nKey Exclusion Criteria:\n\n* Known EGFR, KRAS, NRAS, HRAS, or BRAF oncogenic-driver co-mutation with PI3K\u002FAKT\u002FPTEN alteration\n* Clinically significant abnormalities of glucose metabolism\n* Active brain metastases or carcinomatous meningitis.\n* History of significant hemoptysis or hemorrhage within 4 weeks prior to first dose of study drug\n* Malabsorption syndrome, nausea and vomiting uncontrolled by medication, or disease significantly affecting gastrointestinal function likely to interfere with the delivery, absorption, or metabolism of TER-2013\n* Prior therapy:\n\n  1. \\[For TER-2013 monotherapy escalation\\]: AKT inhibitor\n  2. \\[For TER-2013 monotherapy expansion\\]: AKT\u002FPI3K\u002FPTEN pathway inhibitor\n  3. \\[For TER-2013 + fulvestrant combination expansion\\]: AKT\u002FPI3K\u002FPTEN pathway inhibitor, fulvestrant and other SERDs, mTOR inhibitor; some PIK3CA-altered cohorts allow prior PI3K inhibitor.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria apply","ALL","18 Years",{"count":19,"type":20},205,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a Phase 1\u002F2, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TER-2013 in patients with advanced solid tumors harboring AKT\u002FPI3K\u002FPTEN pathway alterations.",[27,28,29,30,31,32,33,34],"Breast Cancer","Endometrial Cancer","Ovarian Cancer","Lung Squamous Cell Carcinoma","Head and Neck Squamous Cell Carcinoma","Esophageal Squamous Cell Carcinoma","Solid Tumor","Cervical Cancer",[36,27,37,38],"AKT\u002FPI3K\u002FPTEN Alterations","Advanced Solid Tumors","HR+\u002FHER2-","RECRUITING","2026-08-19",{"date":42,"type":43},"2026-08-21","ACTUAL",{"date":45,"type":43},"2025-09-23",{"date":47,"type":20},"2029-02-28",{"name":49,"class":50},"Terremoto Biosciences Inc.","INDUSTRY",18,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":62,"conditions":63,"keywords":74,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100609637","phase-1-a-study-evaluating-the-safety-efficacy-and-pharmacokinetics-pk-of-evolve104-in-participants-with-advanced-urothelial-and-squamous-cell-carcinomas-100609637","NCT07217171","A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas","A Phase 1 Dose-Escalation and Expansion Study Evaluating the Safety, Efficacy, and Pharmacokinetics of EVOLVE104 in Subjects With Advanced Urothelial and Squamous Cell Carcinomas","Key Inclusion Criteria:\n\nParticipants must have locally advanced or metastatic cancer with one of the following tumor types: bladder cancer, squamous cell carcinoma of the lung, esophagus, skin, or an anogenital squamous cell carcinoma.\n\n1. Participant must have documented disease progression during or post treatment with standard of care, dependent upon tumor type.\n2. The cancer must be measurable by CT scan or MRI.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤1.\n4. Anticipated life expectancy of at least 3 months.\n5. Adequate organ function, as indicated by standard blood tests.\n6. Able to provide a fresh or archival tumor biopsy.\n7. Male and female participants must agree to use contraception during the study and for 120 days after the last dose of study drug, except for women who are post-menopausal or surgically sterile.\n\nKey Exclusion Criteria:\n\n1. The participant is a candidate for treatment with a targeted agent known to provide a benefit.\n2. Persistent significant toxicities from prior anticancer therapy.\n3. Brain metastases unless previously treated and stable.\n4. Prior severe or life-threatening immunologic reactions to previous therapies.\n5. Significant medical conditions, including but not limited to:\n\n   * History of clinically significant cardiac disease\n   * Severe esophageal disease such as esophageal rupture or severe erosive esophagitis.\n   * Active inflammatory corneal or conjunctival inflammation, erosion, or ulcerations.\n   * History of cirrhosis or significant portal hypertension.\n   * Uncontrolled or significant infection.\n   * History of certain other cancers in the past 3 years.\n   * History of arterial thrombosis, stroke and transient ischemic attack within 6 months.\n   * Active or uncontrolled HIV, HBV or HCV infection.\n   * Autoimmune or other condition requiring chronic systemic immunosuppression.",{"count":60,"type":20},160,[23],"The goal of this study is to evaluate the safety and effectiveness of EVOLVE104 in participants with advanced urothelial and squamous cell carcinomas who have previously taken standard treatment options, have declined or have been ineligible for treatment with these medications. Participants with advanced or metastatic cancer who meet all eligibility criteria may be eligible to participate in the study.",[64,65,32,66,67,68,69,70,71,72,73],"Bladder Cancer","Squamous Cell Carcinoma of the Lung","Tongue Squamous Cell Carcinoma","Cutaneous Squamous Cell Cancer","Penile Squamous Cell Carcinoma","Anal Squamous Cell Carcinoma","Vulvar Squamous Cell Carcinoma","Cervical Squamous Cell Carcinoma","Vaginal Squamous Cell Carcinoma","Urethral Squamous Cell Carcinoma",[75,76,77,78,79,80,81,82,83],"bladder","lung","esophagus","tongue","penile","anal","vulvar","cervical","vaginal","2026-08-14",{"date":86,"type":43},"2026-08-18",{"date":88,"type":43},"2025-11-13",{"date":90,"type":20},"2031-01-29",{"name":92,"class":50},"EvolveImmune United, Inc",15,{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100576040","phase-1-substudy-06e-umbrella-study-of-combination-therapies-in-esophageal-cancer-mk-3475-06ekeymaker-u06-100576040","NCT06780111","Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E\u002FKEYMAKER-U06)","A Phase 1\u002F2 Open-Label, Umbrella Platform Design Study of Investigational Agents in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy in Participants With 1L Locally Advanced Unresectable\u002FMetastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06E","Inclusion Criteria\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic squamous cell carcinoma of the esophagus in first-line (1L) setting.\n* Has measurable disease per RECIST 1.1 as assessed by the local site. investigator or designee\u002Fradiology assessment and verified by BICR. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.\n* Has had AEs due to previous anticancer therapies that have recovered to ≤Grade 1 or baseline. Endocrine-related AEs that are adequately treated with hormone replacement are elegible.\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Has adequate organ function.\n\nExclusion Criteria\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has had systemic anticancer therapy for locally advanced unresectable or metastatic esophageal cancer.\n* Has tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula.\n* Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.\n* Has clinically significant corneal disease, history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing.\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.\n* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention.\n* Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids.\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n* Has inadequate cardiac function assessed as by a corrected QT interval by Fredericia (QTcF) value ≥470 msec.\n* Has clinically significant cardiovascular disease within 6 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.\n* Has peripheral neuropathy ≥ Grade 2.\n* Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years.\n* Has had a history of interstitial lung disease (ILD)\u002Fpneumonitis irrespective of steroid use (except for a history of radiation pneumonitis that did not require steroids), has a current diagnosis of ILD, or has clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out.\n* Has active infection requiring systemic therapy.\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder.",{"count":102,"type":20},298,[23,24],"Researchers are looking for new ways to treat esophageal squamous cell carcinoma (ESCC). ESCC is a type of cancer that starts in certain cells that line the esophagus. The esophagus is the tube that connects the throat to the stomach. This study will look at ESCC that is either locally advanced unresectable, which means it has spread into tissue near where it started and cannot be completely removed by surgery, or metastatic, which means it has spread to other body parts.\n\nAvailable treatments for these types of ESCC include pembrolizumab and chemotherapy. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing.\n\nResearchers want to learn about giving pembrolizumab and investigational agents, with or without chemotherapy to treat ESCC. Ifinatamab deruxtecan (I-DXd), is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.\n\nThe main goal of this study is to learn about the safety of investigational agents and pembrolizumab with or without chemotherapy and if people tolerate them. Researchers also want to learn how cancer responds (gets smaller or goes away) to the study treatments.",[32],{"date":86,"type":43},{"date":108,"type":43},"2025-07-30",{"date":110,"type":20},"2032-01-04",{"name":112,"class":50},"Merck Sharp & Dohme LLC",41,{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":125,"phases":4,"briefSummary":126,"conditions":127,"keywords":128,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":146},"100652221","standardized-mri-and-structured-reporting-for-esophageal-squamous-cell-carcinoma-100652221","NCT07769658","Standardized MRI and Structured Reporting for Esophageal Squamous Cell Carcinoma","Development and Multicenter Validation of Standardized MRI Acquisition and Structured Reporting for Primary Esophageal Squamous Cell Carcinoma: A Dual-Cohort Study of T Staging and Tumor Regression Grading","ESCC-MRI-TRG","Inclusion Criteria:\n\n* Age 18 to 80 years, inclusive\n* Histologically confirmed esophageal squamous cell carcinoma based on endoscopic biopsy or other tissue examination\n* Primary tumor located in the thoracic esophagus\n* Planned curative esophagectomy\n* Able to complete the required esophageal MRI examination with diagnostically adequate image quality\n* Able and willing to provide written informed consent\n* For Cohort A: no chemotherapy, radiotherapy, immunotherapy, targeted therapy, or other antitumor treatment before MRI; surgery planned within 14 days after MRI; and postoperative pathological T stage expected to be available\n* For Cohort B: neoadjuvant treatment followed by surgery selected by the clinical multidisciplinary team; baseline MRI completed within 14 days before neoadjuvant treatment; post-treatment MRI completed within 14 days before surgery; and pathological tumor regression grade of the primary tumor bed expected to be available\n\nExclusion Criteria:\n\n* Adenocarcinoma, neuroendocrine carcinoma, adenosquamous carcinoma, or another non-squamous histological type\n* Cervical esophageal cancer, a gastric primary tumor extending into the esophagus, or multiple primary lesions that prevent reliable imaging-pathology matching\n* Definite distant metastasis, unresectable T4b disease, or another reason that prevents acquisition of a surgical pathological reference standard\n* Previous esophageal cancer surgery, radiotherapy, or another treatment that substantially altered local esophageal anatomy\n* Contraindication to MRI, or contraindication to the gadolinium-based contrast agent when the required contrast-enhanced sequences cannot be completed\n* Severe claustrophobia, inability to follow breathing instructions, or another cause of nondiagnostic image quality that persists after a safe repeat examination\n* Substantial disease progression, emergency intervention, or off-protocol treatment between MRI and surgery that prevents valid imaging-pathology comparison\n* Inadequate surgical specimen sampling or inability to determine pathological T stage or pathological tumor regression grade","80 Years",{"count":124,"type":20},500,"OBSERVATIONAL","This prospective, multicenter diagnostic accuracy study will develop and validate a standardized 3.0-T magnetic resonance imaging (MRI) acquisition protocol and structured reporting system for primary esophageal squamous cell carcinoma (ESCC). Approximately 500 adults scheduled for curative esophagectomy will be enrolled consecutively into two clinically defined cohorts. In Cohort A, patients proceeding directly to surgery will have MRI-based T staging compared with postoperative pathological T stage. In Cohort B, patients receiving neoadjuvant therapy before surgery will undergo paired MRI assessment, and MRI-based tumor regression grade will be compared with pathological tumor regression grade in the resected primary tumor bed. Imaging will be independently assessed by two radiologists, with adjudication by a third reader. The study will evaluate diagnostic performance, reader agreement, image quality, protocol adherence, reporting completeness, and consistency across participating centers and MRI vendors. Lymph-node staging and nodal treatment response are outside the research scope.",[32],[129,130,131,132,133,134,135],"Esophageal magnetic resonance imaging","Structured reporting","T staging","Tumor regression grade","Diagnostic accuracy","Neoadjuvant therapy","Multicenter study","NOT_YET_RECRUITING","2026-08-12",{"date":86,"type":43},{"date":140,"type":20},"2026-09",{"date":142,"type":20},"2028-09",{"name":144,"class":145},"The First Affiliated Hospital of Zhengzhou University","OTHER",7,{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":21,"phases":156,"briefSummary":158,"conditions":159,"keywords":160,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":173},"100565638","phase-3-a-study-of-ifinatamab-deruxtecan-in-subjects-with-pretreated-advanced-or-metastatic-esophageal-squamous-cell-carcinoma-escc-ideate-esophageal01-100565638","NCT06644781","A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)","A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for randomization into the study:\n\n1. Participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \\>18 years old).\n2. Has histologically or cytologically documented unresectable locally advanced or metastatic ESCC according to American Joint Committee on Cancer 8th edition staging system on ESCC.\n3. Has disease progression post a platinum-based chemotherapy and an ICI treatment per global or local guidelines, with a maximum of 1 prior line of systemic therapy for unresectable advanced or metastatic ESCC.\n4. The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content as defined in the Laboratory Manual.\n5. Has at least 1 measurable lesion on computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) according to RECIST v1.1 as assessed by the investigator. Measurable lesions should not be from a previously irradiated site. If the lesion at a previously irradiated site is the only selectable target lesion, a radiological assessment showing significant progression of the irradiated lesion should be provided by the investigator.\n6. Has an ECOG PS of 0 or 1 within 7 days prior to Cycle 1 Day 1.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.\n2. Has received any topoisomerase inhibitor.\n3. Has histologically or cytologically confirmed adenosquamous carcinoma subtype.\n4. Is ineligible to all the chemotherapies in the comparator arm due to prior progression or intolerance.\n5. Has tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of bleeding or fistula as assessed by the investigator.\n6. Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive or treated brain metastases who are asymptomatic (ie, without neurologic signs or symptoms and not requiring treatment with corticosteroids or anticonvulsants) may be included in the study. Subjects must have a stable neurologic status and discontinue corticosteroid usage for at least 2 weeks prior to Screening.\n7. Has any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event, or pulmonary embolism.\n8. Has a clinically significant corneal disease.\n9. Has a history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required corticosteroids, current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at Screening.\n10. Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study randomization, severe asthma, chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion, etc), and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc), prior pneumonectomy, or requirement for supplemental oxygen.\n11. Is on chronic steroid treatment (dose of 10 mg daily or more prednisone equivalent), except for low-dose inhaled steroids (for asthma\u002FCOPD), topical steroids (for mild skin conditions), or intra-articular steroid injections.",{"count":155,"type":20},510,[157],"PHASE3","This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have experienced disease progression following treatment with a platinum-based systemic therapy and an immune checkpoint inhibitor (ICI) compared with investigator's choice of chemotherapy (ICC).",[32],[161,162,163],"Esophageal squamous cell carcinoma","Ifinatamab deruxtecan (I-DXd)","DS-7300a","2026-08-03",{"date":166,"type":43},"2026-08-04",{"date":168,"type":43},"2025-03-27",{"date":170,"type":20},"2029-11-01",{"name":172,"class":50},"Daiichi Sankyo",132,{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":21,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":198},"100642953","phase-3-surgery-vs-radical-chemoradiotherapy-for-esophageal-scc-after-neoadjuvant-immunochemotherapy-100642953","NCT07629817","Surgery vs. Radical Chemoradiotherapy for Esophageal SCC After Neoadjuvant Immunochemotherapy","A Multicenter, Open-Label, Randomized Controlled Phase III Clinical Trial Comparing Surgery Versus Radical Chemoradiotherapy (Organ Preservation) in Patients With Thoracic Esophageal Squamous Cell Carcinoma Achieving cCR or cPR Following Neoadjuvant Immunochemotherapy","HCHTOG2603","Inclusion Criteria:\n\n1. Age 18-75 years, any sex.\n2. ECOG Performance Status 0-1.\n3. Histologically confirmed, previously untreated thoracic esophageal squamous cell carcinoma (ESCC).\n4. Clinical stage cT2N0M0, T3N0-2M0 (AJCC 8th Edition), assessed as resectable with a potential for R0 resection by endoscopic ultrasound (EUS), PET-CT, and contrast-enhanced CT. Patients with cervical lymph node metastasis may also be included if deemed suitable for three-field lymphadenectomy by a multidisciplinary team assessment.\n5. Adequate bone marrow, hepatic, and renal function:\n\n   * Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL, Platelet count ≥ 100 × 10⁹\u002FL, Hemoglobin ≥ 90 g\u002FL.\n   * Alanine aminotransferase \u002F Aspartate aminotransferase ≤ 2.5 × Upper Limit of Normal, Total bilirubin ≤ 1.5 × Upper Limit of Normal.\n   * Serum creatinine ≤ 1.5 × Upper Limit of Normal or Creatinine clearance ≥ 60 mL\u002Fmin.\n6. Signed written informed consent form (ICF).\n\nExclusion Criteria:\n\n1. History of other malignancy within the past 5 years.\n2. Active autoimmune disease.\n3. Active Hepatitis B Virus (HBV) \u002F Hepatitis C Virus (HCV) \u002F Human Immunodeficiency Virus (HIV) infection.\n4. Severe cardiac or pulmonary insufficiency (Left Ventricular Ejection Fraction \\\u003C 50%, Forced Expiratory Volume in 1 second \\\u003C 1 L).\n5. Pregnancy or lactation.","75 Years",{"count":184,"type":20},1044,[157],"This is a Phase III, multicenter, open-label, randomized controlled trial. The study aims to compare organ preservation versus esophagectomy in patients with locally advanced, resectable thoracic esophageal squamous cell carcinoma (ESCC) who achieve a complete or partial clinical response (cCR\u002FcPR) following neoadjuvant immunochemotherapy.",[32],"2026-07-30",{"date":190,"type":43},"2026-07-31",{"date":192,"type":43},"2026-06-16",{"date":194,"type":20},"2032-03-15",{"name":196,"class":197},"Henan Cancer Hospital","OTHER_GOV",1,{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":21,"phases":208,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":222},"100635579","phase-2-a-study-to-evaluate-efficacy-and-safety-of-tislelizumab-plus-chemotherapy-for-locally-advanced-unresectable-or-metastatic-gastric-or-gastroesophageal-adenocarcinoma-and-esophageal-squamous-cell-carcinoma-in-racial-and-ethnic-minority-patients-in-the-united-states-100635579","NCT07554521","A Study to Evaluate Efficacy and Safety of Tislelizumab Plus Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in Racial and Ethnic Minority Patients in the United States","An Open-Label, Single-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab Plus Chemotherapy in a First-Line Setting for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in US Racial and Ethnic Minority Patients","Inclusion Criteria:\n\n* Self-identifies as a member of racial and\u002For ethnic minority populations as defined by the Food and Drug Administration (FDA), such as Black or African American, Hispanic or Latino, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander\n* Histologically confirmed, locally advanced unresectable or metastatic gastric or gastroesophageal adenocarcinoma (GAC\u002FGEA) or esophageal squamous cell carcinoma (ESCC)\n* No previous systemic therapy for locally advanced unresectable or metastatic GAC\u002FGEA or ESCC\n* At least 1 measurable lesion per RECIST v1.1 as determined by investigator assessment\n* Patients must have positive tumor programmed death-ligand 1 (PD-L1) expression. Documented PD-L1 results are acceptable\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1\n* Adequate organ function as indicated by the following laboratory values ≤ 14 days prior to study treatment\n* Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 120 days after the last dose of tislelizumab and ≥ 180 days after the last dose of chemotherapy, and have a negative urine or serum pregnancy test ≤ 7 days prior to study treatment\n* Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab and ≥ 180 days after the last dose of chemotherapy\n\nExclusion Criteria:\n\n* Patient has squamous cell or undifferentiated or other histological type gastric cancer\n* Active leptomeningeal disease or uncontrolled brain metastasis. Patients with equivocal findings or with confirmed brain metastases are eligible for enrollment provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment for ≥ 4 weeks before study treatment.\n* Patients with evidence of esophageal\u002Fbronchial or esophageal\u002Faorta fistula, or complete esophageal obstruction not amenable to treatment.\n* Diagnosed with GAC\u002FGEA with positive human epidermal growth factor receptor 2 (HER2). Results of the tumor HER2 testing must be known prior to study treatment\n* Active autoimmune diseases or history of autoimmune diseases that may relapse Note: Patients with the following diseases are not excluded and may proceed to further screening:\n\n  1. Controlled Type I diabetes\n  2. Hypothyroidism (provided it is managed with hormone replacement therapy only)\n  3. Controlled celiac disease\n  4. Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia)\n  5. Any other disease that is not expected to recur in the absence of external triggering factors\n* Any active malignancy ≤ 2 years before study treatment, with the exception of the specific cancer under investigation in this trial or any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)\n* Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and\u002For diuretics within 7 days prior to study treatment (the cytological confirmation of any effusion is permitted)\n* Have clinically significant bleeding (Common Terminology Criteria for Adverse Events (CTCAE) ≥ Grade 2) from the GI tract within 1 month prior to study treatment\n* Have a history of gastrointestinal (GI) perforation (CTCAE ≥ Grade 2) and\u002For fistulae (including prior gastric fistula operation) within 6 months prior to study treatment\n* Have a clinically significant bowel obstruction (CTCAE ≥ Grade 2)\n* Any condition that required systemic treatment with either corticosteroids (\\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before study treatment.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":207,"type":20},30,[24],"The purpose of this study is to characterize the clinical effects of tislelizumab, including pharmacokinetics (PK), activity, and safety assessments in US racial and ethnic minority patients with human epidermal growth factor receptor 2 (HER2)-negative, programmed death-ligand 1(PD-L1)-positive, unresectable or metastatic gastric or gastroesophageal cancer (GAC\u002FGEA) or esophageal squamous cell carcinoma (ESCC). The study duration will be up to approximately 6 years.",[211,32,212],"Advanced Unresectable Gastric Adenocarcinoma","Advanced Gastroesophageal Adenocarcinoma","2026-07-21",{"date":215,"type":43},"2026-07-22",{"date":217,"type":43},"2026-04-30",{"date":219,"type":20},"2031-12-31",{"name":221,"class":50},"BeOne Medicines",6,{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":21,"phases":232,"briefSummary":233,"conditions":234,"keywords":246,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":207},"100599900","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-08046876-in-people-with-advanced-solid-tumors-100599900","NCT07090499","A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors","A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.","Inclusion Criteria:\n\n* 18 years of age or older\n* Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas\n* Measurable disease\n* ECOG Performance status 0-1\n* Part 1: progression or relapse following standard treatments\n* Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting\n* Resolution of acute effects of prior anticancer therapy to baseline or Grade 1\n* Consent to submit required pre-treatment tumor tissue as medically feasible\n\nExclusion criteria:\n\n* Received prior treatment with an antibody drug conjugate with a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan )\n* Active anorexia, nausea or vomiting, and\u002For signs of intestinal obstruction meeting protocol exclusion\n* Pulmonary disease meeting protocol exclusion\n* Other unacceptable abnormalities as defined by protocol",{"count":231,"type":20},310,[23],"The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'. ADCs are anticancer drugs designed to stick to cancer cells and kill them.\n\nThe study drug will be given to participants through a needle in a vein (intravenous infusion). This study includes multiple parts. In the first part of the study, there will be different groups of people receiving different doses of the study drug. The study may also test different schedules.",[235,64,236,237,238,239,240,241,242,32,243,244,245],"Advanced\u002FMetastatic Solid Tumors","Urothelial Carcinoma","Advanced Non-Small Cell Lung Cancer","Carcinoma, Non Small Cell Lung","Carcinoma, Squamous Cell of Head and Neck","Head and Neck Cancer","Esophageal Cancer","Gastroesophageal Junction Adenocarcinoma","Esophageal Adenocarcinoma","Pancreatic Adenocarcinoma","Pancreatic Cancer",[247,248,249,250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269],"B6C","integrin beta 6","ADC","antibody drug conjugate","bladder cancer","urothelial carcinoma","non-small cell lung cancer","NSCLC","head and neck cancer","HNSCC","SCCHN","esophageal cancer","EC","esophageal squamous cell carcinoma","gastroesophageal junction adenocarcinoma","pancreatic cancer","PDAC","pancreatic adenocarcinoma","esophageal adenocarcinoma","lung adenocarcinoma","lung squamous cell carcinoma","integrin alpha-v beta-6 receptor","ITGB6",{"date":215,"type":43},{"date":272,"type":43},"2025-08-20",{"date":274,"type":20},"2029-07-08",{"name":276,"class":50},"Pfizer",{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":21,"phases":286,"briefSummary":287,"conditions":288,"keywords":294,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":304,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":311},"100455301","phase-1-a-study-of-pf-08046054sgn-pdl1v-in-advanced-solid-tumors-100455301","NCT05208762","A Study of PF-08046054\u002FSGN-PDL1V in Advanced Solid Tumors","A Phase 1 Study of PF-08046054\u002FSGN-PDL1V in Advanced Solid Tumors","Inclusion Criteria:\n\n* Parts A and B:\n\n  * Participants must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor types\n\n    * Non-small cell lung cancer (NSCLC)\n    * Head and neck squamous cell carcinoma (HNSCC) (except nasopharyngeal cancer)\n    * Esophageal squamous cell carcinoma (SCC)\n    * Triple negative breast cancer (TNBC)\n  * Participants must have disease that is relapsed or refractory, that has progressed on approved therapies, be intolerant to or refused such therapies, or such and therapies are contraindicated and in the judgement of the investigator, should have no appropriate SoC therapeutic option\n  * Participants must have PD-L1 expression based on historical testing\n* Part C:\n\n  * Participants must have disease that is relapsed or refractory or be intolerant to SoC therapies and must have one of the following tumor types\n\n    * HNSCC\n\n      * Participants with HNSCC must have histologically or cytologically-confirmed HNSCC\n    * NSCLC\n\n      * Participants must have histologically or cytologically-confirmed NSCLC. Participants with SCC and non--SCC histology are eligible. Note: Participants with a neuroendocrine component or histology are not eligible.\n    * Esophageal SCC\n    * Pancreatic cancer\n    * Hepatocellular carcinoma\n    * TNBC\n    * Gastric cancer\n    * Endometrial cancer\n  * Participants must have been previously tested for PD-L1 expression and should have PD-L1 expression ≥1 or \\\u003C1 by CPS or TPS based on historical testing\n* Part D and Part E:\n\n  * Participants must have histologically or cytologically-confirmed disease of the HNSCC or NSCLC\n  * Participants must have PD-L1 expression based on historical testing\n  * Participants with NSCLC; PD-L1 expression ≥ 1% by TPS\n  * Participants with HNSCC; PD--L1 expression ≥1 by CPS\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Measurable disease per RECIST v1.1 at baseline\n\nExclusion Criteria:\n\n* History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy.\n* Known active central nervous system metastases. Participants with previously-treated brain metastases may participate provided they:\n\n  * Are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment\n  * Have no new or enlarging brain metastases\n  * And are off of corticosteroids prescribed for symptoms associate with brain metastases for at least 7 days prior to first dose of study treatment\n* Lepto-meningeal disease\n* Prior treatment with an anti-PD-L1 agent within less than 5 half-lives. This duration of time will vary according to the half-life of the specific agent.\n* Previous receipt of an monomethylauristatin E (MMAE)-containing agent.\n* Pre-existing neuropathy ≥Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.\n\nThere are additional inclusion criteria. The study center will determine if criteria for participations are met.",{"count":285,"type":20},714,[23],"This study will test the safety of a drug called PF-08046054\u002FSGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease.\n\nParticipants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).\n\nThis study will have five parts. Parts A and B of the study will find out how much PF-08046054\u002FSGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054\u002FSGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054\u002FSGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.",[289,290,32,291,292,28,244,293],"Carcinoma, Non-Small-Cell Lung","Squamous Cell Carcinoma of the Head and Neck","Triple Negative Breast Neoplasms","Gastric Cancer","Hepatocellular Carcinoma",[295,254,296,256,297,298,299,300,301,263,302,276,303],"Non-small cell lung cancer","Head and neck squamous cell carcinoma","Triple Negative Breast Cancer","TNBC","Gastric cancer","Seattle Genetics","HCC","Esophageal","Endometrial",{"date":215,"type":43},{"date":306,"type":43},"2022-10-25",{"date":308,"type":20},"2029-01-04",{"name":310,"class":50},"Seagen, a wholly owned subsidiary of Pfizer",62,{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":319,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":21,"phases":322,"briefSummary":324,"conditions":325,"keywords":327,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":340},"100441465","novel-strategy-for-early-detection-of-esophageal-squamous-cell-carcinoma-100441465","NCT05028725","Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma","Investigation of a Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\nESCC Cases (Group 1):\n\n* Male or female \\>= 18 years of age at screening visit.\n* Patients are currently seen for clinical care at Muhimbili National Hospital (MNH)-Upanga or at MNH-Mloganzila.\n* Patient meets one of the following two criteria-\n* Patients with a confirmed diagnosis of ESCC as evidenced by histological confirmation OR\n* Patient planned to undergo EGD with biopsy for suspected ESCC based upon any one of the following clinical criteria: (1) findings on computed tomography (CT) scan; (2) findings on barium swallow; (3) findings on endoscopy without biopsy confirmation, (4) symptoms of dysphagia and\u002For odynophagia without an alternative explanation for these symptoms.\n* Patient must be able to swallow liquid (Ogilvie's score \\\u003C 3).\n* Patients must be well enough to participate in a 20-minute interview or have a close relative who is able to do so on their behalf.\n* Patients must be willing to be contacted either in person or via phone 7-10 days following administration of the 'EsophaCap' sponge device.\n* Native of Tanzania.\n* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.\n\nNon-ESCC study participants (Group 2):\n\n* Male or female ≥ 18 years of age at screening visit.\n* Patients are currently seen for clinical care at MNH-Upanga or at MNH-Mloganzila.\n* Patient is scheduled to undergo EGD for a suspected non-malignant condition with no symptoms concerning for esophageal cancer (i.e. dysphagia or odynophagia).\n* Patient must be able to swallow liquid (Ogilvie's score \\\u003C 3).\n* Patients must be well enough to participate in a 20-minute interview or have a close relative who is able to do so on their behalf.\n* Patients must be willing to be contacted either in person or via phone 7-10 days following administration of the 'EsophaCap' sponge device.\n* Native of Tanzania.\n* Written informed consent (and assent when applicable) obtained from participant or participant's legal representative and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\nESCC Cases (Group 1):\n\n* Known pregnancy during participation in the study.\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n* Clinical instability (i.e. hypotension or a recent cardiovascular event).\n* Any history of upper gastrointestinal bleeding within the past 3 months (including reported history of hematemesis and\u002For melena).\n* Diagnosis of peptic ulcer disease within the last 3 months.\n* Known history of esophageal varices.\n* Patients taking anticoagulation or antiplatelet therapy\u002Fmedication (warfarin, clopidogrel, aspirin, heparin or enoxaparin) for high-risk conditions.\n* Patients with an active extra-esophageal malignancy (not currently in remission).\n* Patient with a known history of a non-malignant esophageal stricture.\n* Patients with esophageal stents currently in place.\n* Patients with a history of radiation therapy to the head, neck, any part of the gastrointestinal tract (including esophagus) or thorax.\n* Patients who have previously received chemotherapy in the last 12 months\n* Patients with any history of major surgery for esophageal cancer (e.g. esophageal bypass, esophagectomy, etc.).\n* Patients who have a known history of or clinical symptoms concerning for tracheoesophageal fistula (aspiration history, severe cough)\n* Patients with a known history of small bowel obstruction\n* Patients with a history of bleeding complications during esophageal biopsy.\n* Patients with any history of a head and neck malignancy.\n* Patients with a known bleeding disorder\n* Patients with known thrombocytopenia (less than 50,000 platelets per microliter)\n* Individuals who are not permanent residents or natives of Tanzania.\n* Inability to follow instructions.\n* Unable to provide informed consent.\n\nNon-ESCC study participants (Group 2):\n\n* Known pregnancy during participation in the study.\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n* Clinical instability (i.e. hypotension or a recent cardiovascular event).\n* Any history of upper gastrointestinal bleeding within the past 3 months (including reported history of hematemesis and\u002For melena).\n* Diagnosis of peptic ulcer disease within the last 3 months.\n* Known history of esophageal varices.\n* Patients taking anticoagulation or antiplatelet therapy\u002Fmedication (warfarin, clopidogrel, aspirin, heparin or enoxaparin) for high-risk conditions.\n* Patients with an active extra-esophageal malignancy (not currently in remission) or any history of a non-cutaneous malignancy diagnosed within the previous five years.\n* Patient with a known history of esophageal strictures disabling passage of the capsule.\n* Patient with esophageal stents currently in place.\n* Patients with a history of radiation therapy to the head, neck, any part of the gastrointestinal tract (including esophagus) or thorax.\n* Patients with a known history of small bowel obstruction\n* Patients with a known bleeding disorder\n* Patients with known thrombocytopenia (less than 50,000 platelets per microliter)\n* Individuals who are not permanent residents or natives of Tanzania.\n* Allergy to iodine\n* Presence of goiter.\n* Inability to follow instructions.\n* Unable to provide informed consent",true,{"count":321,"type":20},289,[323],"NA","In the current protocol, we propose a study to evaluate a novel, combined esophageal sponge-methylation biomarker strategy for the early detection of esophageal squamous cell carcinoma (ESCC) as well as its precursor, esophageal squamous dysplasia (ESD). This strategy leverages the 'EsophaCap', a swallowable, retrievable sponge, with subsequent evaluation of the sample using a novel molecular biomarker assay. This biomarker assay evaluates methylation levels in select genes, which have been shown to differ significantly between ESCC cases and controls in pilot studies. Detection of methylation markers highly associated with ESCC could help identify patients with concurrent ESCC or at high risk of imminently developing this condition. If successful, this strategy could result in a paradigm shift for esophageal cancer control strategies in Tanzania and other high-incidence ESCC regions.",[32,326],"Esophageal Squamous Dysplasia",[328,329,330,331],"EsophaCap","Biomarker Detection","Cancer Detection","Chromoendoscopic screening",{"date":333,"type":43},"2026-07-23",{"date":335,"type":43},"2022-05-16",{"date":337,"type":20},"2027-12-31",{"name":339,"class":145},"University of California, San Francisco",2,{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":21,"phases":350,"briefSummary":351,"conditions":352,"keywords":367,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":146},"100519732","phase-1-safety-and-efficacy-of-neo212-in-patients-with-astrocytoma-idh-mutant-glioblastoma-idh-wildtype-or-brain-metastasis-100519732","NCT06047379","Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis","An Open-label Phase 1\u002F2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients With Select Solid Tumors.","Inclusion Criteria:\n\n* Patient must be ≥ 18yrs of age.\n* Patient must have the ability to understand, and the willingness to sign, a written informed consent form.\n* Patient has been on a stable or decreasing dose of steroids for at least five days prior to the date of informed consent.\n* Any toxicity from prior therapy must be resolved or at maximum Grade 1 prior to initiation of NEO212.\n* If progression of disease occurs within 90 days or conformal radiation, the progression\u002Frecurrence must be outside of the radiation field or proven by biopsy\u002Fresection.\n* Patient with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype must have a Karnofsky Performance Status (KPS) of ≥ 60.\n* Patient with select solid tumors must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Patient must have an expected survival or at least three months.\n* Patient must have a baseline MRI of the brain with gadolinium within 14 days of administration of NEO212.\n* Patient with select solid tumors must have a baseline CT scan with IV contrast and oral contrast of neck, chest, abdomen and pelvis within 14 days of administration of NEO212.\n* Patients must be able to comply with all study assessments.\n* If patient suffers from seizures (s)he must be controlled on a stable dose of anti-epileptics for 14-days prior to the date of informed consent.\n* Patient must have adequate organ and marrow function as follows:\n\n  * Absolute neutrophil count ≥ 1,500\u002Fmicroliter\n  * Platelets ≥ 100,000\u002Fmicroliter\n  * Total bilirubin within normal institutional limits\n  * AST (SGOT) \u002F ALT (SPGT) ≤ 2.5 x institutional upper limit of normal\n  * Creatinine clearance (CrCl) of \\>60 mL\u002Fmin (using the Cockcroft-Gault formula or 24- hour urine collection).\n* Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first dose of NEO212, for the duration of study participation, and for 90 days following completion of therapy.\n\nA female of child-bearing potential is any women (regardless of sexual orientation, not having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy; or\n* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses at any time in the preceding 12 consecutive months).\n* A negative serum pregnancy test will be required of all female patients of child-bearing potential within seven days prior to the receipt of NEO212.\n* A serum pregnancy test will be repeated immediately if pregnancy is suspected.\n\nPhase 1: (dose escalation)\n\n* Patient must:\n\n  * have radiographically confirmed Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype following previous radiation therapy or treatment with temozolomide and radiation, or\n  * have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.\n* Patients receiving prior systemic therapy must have a minimum wash-out period (defined as the period prior to receipt of the first dose of NEO212) of:\n\n  * 28 days or 5 half-lives (whichever is shorter) elapsed from the administration from any experimental agent;\n  * 2 weeks from administration of immunotherapies;\n  * 28 days from administration of cytotoxic agents; and\n  * 7 days from administration of non-cytotoxic agents (interferon, tamoxifen, thalidomide, cis-retinoic acid, and herbal medicine).\n\nNOTE: No washout is necessary for alternating electrical fields.\n\nPhase 2a: (safety run-in)\n\n* Patient must have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.\n* Patients receiving prior systemic therapy must be receiving one of the protocol approved Standard of Care (SOC) regimens.\n* Patient must have measurable\u002Fevaluable CNS disease per RANO or RANO-BM criteria.\n* Patient must have measurable\u002Fevaluable systemic disease per RECIST v1.1 criteria.\n\nPhase 2b: (efficacy)\n\n* Patient must:\n\n  * have radiographically confirmed Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype following previous radiation therapy or treatment with temozolomide and radiation, or\n  * have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.\n* Patients receiving prior systemic therapy must be receiving one of the protocol approved Standard of Care (SOC) regimens.\n* Patient must have measurable\u002Fevaluable CNS disease per RANO or RANO-BM criteria\n* Patient with select solid tumors must have measurable\u002Fevaluable systemic disease per RECIST v1.1 criteria.\n* Creatinine clearance (CrCl) of \\>60 mL\u002Fmin (using the Cockcroft-Gault formula or 24-hour urine collection). Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first dose of NEO212, for the duration of study participation, and for 90 days following completion of therapy.\n\nExclusion Criteria: (all Phases)\n\n* Patient in Phase 1 concurrently receiving any other antitumor therapy.\n* Patient in Phase 2a or 2b who is concurrently receiving any SOC therapy not listed in Appendix 1.\n* Patients with metastases to the spinal cord parenchyma.\n* Patients with metastases to the meninges.\n* Patient has received stereotactic or highly conformal radiotherapy to CNS lesions within 2 weeks before receipt of NEO212.\n* Patient with history of known leptomeningeal involvement.\n* Patient has prior history or new diagnosis of secondary cancer within five years prior to the date of informed consent, except for basal cell carcinoma or squamous cell carcinoma of the skin.\n* Patient has a corrected QT interval (using Fridericia's correction formula) (QTcF) of \\>470 msec, a history of additional risk factors for TdP (e.g. heart failure, hypokalemia), and\u002For the use of concomitant medications that prolong QT\u002FQTc interval.\n* Patient had surgery within 7 days prior to the date of informed consent.\n* Patient has not recovered to Grade 1 from treatment related adverse events due to chemotherapy, immunotherapy, or radiation therapy.\n* Patient had prior treatment with perillyl alcohol.\n* Patient has a history of allergic reactions attributed to perillyl alcohol.\n* Patients in Phase 2b with Astrocytoma IDH-mutant, or Glioblastoma IDH-wildtype who have had more than one recurrence or progression of his\u002Fher primary CNS tumor(s).",{"count":349,"type":20},134,[23,24],"This multi-site, Phase 1\u002F2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 alone for the treatment of patients with radiographically-confirmed progression of Astrocytoma IDH- mutant, Glioblastoma IDH-wildtype, and the safety, pharmacokinetics and efficacy of a repeated dose regimen of NEO212 when given with select SOC for the treatment of solid tumor patients with radiographically confirmed uncontrolled metastases to the brain.\n\nThe study will have three phases, Phase 1, Phase 2a and Phase 2b.",[353,354,355,34,356,241,32,292,242,31,357,358,359,360,361,362,363,364,365,366,236],"Diffuse Astrocytoma, IDH-Mutant","Glioblastoma, IDH-wildtype","Brain Metastases, Adult","Colorectal Cancer","Melanoma","Merkel Cell Carcinoma","Microsatellite Instability-High Solid Malignant Tumor","Mismatch Repair Deficient Solid Malignant Tumor","Microsatellite Instability-High Colorectal Cancer","Mismatch Repair Deficient Colorectal Cancer","Non-small Cell Lung Cancer","Renal Cell Carcinoma","Small Cell Lung Cancer","Squamous Cell Carcinoma",[368,369,370,371,372,373,374,375,376,377,378,379],"Astrocytoma","IDH-mutant","Glioblastoma","IDH-wildtype","Brain Metastases","CNS Tumor","GBM","NeOnc","Anova","NEO212","NEO100","TMZ","2026-07-15",{"date":382,"type":43},"2026-07-16",{"date":384,"type":43},"2023-11-01",{"date":386,"type":20},"2027-08-31",{"name":388,"class":50},"Neonc Technologies, Inc.",{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":319,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":21,"phases":399,"briefSummary":400,"conditions":401,"keywords":405,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":340},"100500670","phase-1-safety-of-rad301-in-healthy-human-volunteers-and-patients-with-pancreatic-cancer-or-other-solid-tumors-100500670","NCT05799274","Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Cancer or Other Solid Tumors","Characterizing the Radiochemical and Radiation Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Ductal Adenocarcinoma or Other Solid Tumors","RAD301","Inclusion Criteria:\n\n1. Must be ≥ 18 years of age at the time of informed consent.\n2. All participants must be willing and able to give informed consent.\n3. For patients with cancer: have a history of histologically or cytologically confirmed PDAC, non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma, cervical cancer, endometrial cancer, or ovarian cancer and have had a SOC CT or MRI within 12 weeks prior to giving consent that indicates the presence of at least 1 site of new or residual disease. If the SOC CT or MRI has occurred prior to 12 weeks, consultation with the Sponsor must be sought prior to patient enrollment. SOC images must be available for submission to the centralized imaging reader as reference.\n4. Screening laboratory values within 30 days prior to administration of the study drug:\n\n   1. WBC ≥ 1200\u002FμL\n   2. ANC ≥ 1000\u002FμL\n   3. Platelets ≥ 75,000\u002FμL\n   4. Hemoglobin ≥ 9.0 g\u002FdL\n   5. Creatinine ≤ 1.5 mg\u002FdL\n   6. AST\u002FALT ≤ 3 x ULN for patients with no liver metastases.\n   7. AST\u002FALT ≤ 5 x ULN for patients with liver metastases.\n   8. Bilirubin ≤ 1.5 mg\u002FdL except for participants with Gilbert's disease.\n5. Patients should have a life expectancy of ≥ 12 weeks as judged by the Investigator.\n6. All participants must have baseline pulse oximetry ≥ 95% on room air.\n7. Unremarkable ECGs, with PR intervals of less than 200 msec and QTcF intervals (corrected with Frederica's method) of less than 450 msec.\n8. Willing to refrain from taking illicit drugs one week prior to PET scanning and through the follow-up phone call on Day 3 (+2 days).\n9. Willing to refrain from donating blood for 4 weeks after administration of RAD301.\n10. Have not participated in any other research study that requires taking medication within 4 weeks (or 10 half-lives, whichever is shorter) from the time of informed consent to the end of the Imaging and Safety Follow-Up Period. Previous or ongoing participation in another study should be discussed with the Sponsor.\n\nExclusion Criteria:\n\n1. Participant may not be a member of a vulnerable population defined as participants who are not able to understand the nature of the trial and provide informed consent or who have any medical, psychological or sociological condition that in the opinion of the investigator would interfere with the ability to give consent or interfere with protocol compliance.\n2. Women may not be pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to administration of RAD301.\n3. History of an anaphylactic reaction to a protein- or peptide-derived therapeutic or a diagnostic agent.\n4. History, physical examination, or clinical laboratory tests suggestive of a condition, disorder, or disease that could adversely affect drug absorption, distribution, metabolism, or elimination of RAD301, including chronic liver or renal failure.\n5. Unable to tolerate the study procedures.\n6. Patients with brain metastases are eligible as long as there is no requirement for high doses of systemic corticosteroids that could result in immunosuppression (\\>10 mg\u002Fday prednisone equivalents) for at least 2 weeks prior to study drug administration. An MRI is not required to rule out brain metastases or leptomeningeal metastases\n7. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, or interfere with the interpretation of study results.\n8. Clinically significant cardiovascular\u002F cerebrovascular disease defined as cerebral vascular accident, stroke, carotid artery disease transient ischemic attach (\\\u003C 6 months prior to enrollment), myocardial infarction (\\\u003C 6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class \\>II) or serious cardiac arrhythmia.\n9. Other than the tumor types being studied, a prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast.\n10. Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n11. Participants who underwent major surgery within 4 weeks of administration of study drug (not including diagnostic laparoscopy).",{"count":398,"type":20},9,[23],"This is a Phase 1a, open label, single dose, extended study of safety and biokinetics of RAD301 in healthy human volunteers and individuals with PDAC or Other Solid Tumors",[402,403,404,32,34,28,29],"Healthy Volunteers","Pancreatic Ductal Adenocarcinoma","Non-small Cell Lung Cancer (NSCLC)",[403,406,260,407,408,409],"non-small cell lung cancer (NSCLC)","cervical cancer","endometrial cancer","ovarian cancer",{"date":411,"type":43},"2026-07-17",{"date":413,"type":43},"2023-11-09",{"date":415,"type":20},"2026-08",{"name":417,"class":50},"Radiopharm Theranostics, Ltd",{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":21,"phases":427,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":4},"100646786","phase-2-becotatug-vedotin-plus-tislelizumab-and-low-dose-lenvatinib-for-advanced-esophageal-squamous-cell-carcinoma-phase-ii-100646786","NCT07686926","Becotatug Vedotin Plus Tislelizumab and Low-Dose Lenvatinib for Advanced Esophageal Squamous Cell Carcinoma, Phase II","Becotatug Vedotin Combined With Tislelizumab and Low-Dose Lenvatinib in Patients With Advanced Esophageal Squamous Cell Carcinoma Who Failed First-Line Therapy: A Phase II Exploratory Study","Inclusion Criteria:\n\n1.Age ≥ 18 years, male or female. 2.Histopathologically or cytologically confirmed recurrent or metastatic esophageal squamous cell carcinoma.\n\n3.Failed first-line or above standard systemic therapy for advanced disease. 4.Patients must be able to provide tumor specimens (paraffin blocks, paraffin-embedded sections, or fresh tissue sections) from primary or metastatic lesions for pathological testing. The most recent archived tumor tissue specimen may be used. If archived tissue is unavailable, a new biopsy is required.\n\n5.ECOG PS 0-2. 6.Expected survival ≥ 3 months. 7.At least one measurable target lesion assessable by CT or MRI according to RECIST version 1.1 criteria.\n\n8.Adequate organ and bone marrow function, as demonstrated by the following laboratory values:\n\n1. Bone marrow: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL；Platelet count (PLT) ≥ 100×10⁹\u002FL；Hemoglobin (HGB)≥90 g\u002FL.\n2. Liver: Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×ULN; for patients with liver metastases, ALT and AST≤5×ULN.\n3. Kidney: Creatinine clearance (Ccr) ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n4. Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (except for patients receiving therapeutic anticoagulation).\n5. Cardiac function: No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥ 50%.\n\n9.Female patients of childbearing potential must agree to use contraception during the study and for 6 months after the end of study participation, have a negative serum or urine pregnancy test within 7 days prior to study enrollment, and must not be breastfeeding. Male patients must agree to use contraception during the study and for 6 months after the end of study participation.\n\n10.Patients must be able and willing to comply with the scheduled visits, treatment plans, laboratory tests, and other study-related procedures as outlined in the protocol.\n\n11.Patients must be able to understand the study and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Prior malignancy within 5 years, except for carcinoma in situ, basal cell carcinoma, or other malignancies considered cured with negligible risk of recurrence.\n2. Known hypersensitivity to any component of the study regimen.\n3. High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation.\n4. Untreated or unstable parenchymal brain metastases, spinal cord metastasis or compression, leptomeningeal disease, or meningeal metastases.\n5. Evidence of active infection, including:1）Hepatitis B (HBsAg positive with HBV DNA ≥ 2000 IU\u002FmL, excluding drug-induced or other causes of hepatitis);2）Hepatitis C (anti-HCV antibody positive with HCV RNA above the lower limit of detection);3）Human immunodeficiency virus (HIV) infection;4）Uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infections that have not resolved prior to study drug administration.\n6. Third-space fluid that cannot be controlled by drainage (e.g., massive ascites, pleural effusion, pericardial effusion), or subjects requiring drainage to control third-space fluid within 14 days prior to first dose.\n7. Any severe or uncontrolled systemic disease in the investigator's judgment.\n8. Poorly controlled cardiac disease, including:\n\n1）Heart failure \\> New York Heart Association (NYHA) class II; 2）Unstable angina pectoris; 3）Myocardial infarction within 1 year; 4）Clinically significant supraventricular or ventricular arrhythmias requiring treatment; 5）Long QT syndrome, with QTcF \\> 450 ms (male) or QTcF \\> 470 ms (female). 9.History of primary immunodeficiency or active autoimmune disease, or current use of immunosuppressants or systemic corticosteroids (≥ 10 mg\u002Fday prednisone or equivalent) continuing within 2 weeks prior to enrollment.\n\n10.History of or concomitant interstitial lung disease (ILD), radiation pneumonitis, severe chronic obstructive pulmonary disease (COPD), severe pulmonary insufficiency, or symptomatic bronchospasm.\n\n11.Positive serum pregnancy test or breastfeeding females who do not agree to use adequate contraception during the study and for 6 months after the last dose of study drug.\n\n12.History of organ transplantation, including allogeneic peripheral stem cell or bone marrow transplantation.\n\n13.Peripheral neuropathy ≥ Grade 2 (per CTCAE version 5.0). 14.Prior receipt of any of the following treatments:\n\n1. Intravenous antibiotic therapy within 7 days prior to first dose.\n2. Investigational drug from another clinical trial within 4 weeks prior to first dose.\n3. Live attenuated vaccine within 4 weeks prior to first dose. Inactivated seasonal influenza vaccines or approved non-replicating COVID-19 vaccines are permitted.\n4. Systemic immunostimulatory agents (including but not limited to interferon, interleukin-2, etc.) within 4 weeks prior to first dose.\n5. Major surgical procedure (e.g., abdominal or thoracic surgery, excluding diagnostic puncture, infusion device placement, or gastrointestinal stent placement) within 4 weeks prior to first dose, or anticipation of major surgery not directed at the tumor during the study treatment period.\n\n   15.History of substance abuse (psychoactive drugs) that cannot be abstained from, or psychiatric disorders.\n\n   16.Concurrent participation in another interventional clinical study. 17.Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this clinical trial.",{"count":426,"type":20},36,[24],"Immunotherapy combined with chemotherapy has become the first-line standard of care for advanced esophageal squamous cell carcinoma (ESCC), significantly improving patient survival. However, with the widespread adoption of first-line immunotherapy, most patients eventually develop immune resistance. After first-line treatment failure, there is currently no established standard effective therapy for second-line ESCC. Therefore, more effective and safer treatment options are urgently needed for second-line advanced ESCC.\n\nThis is a prospective, single-arm, single-center, open-label, Phase II clinical study aiming to evaluate the efficacy and safety of Becotatug Vedotin combined with Tislelizumab and low-dose Lenvatinib in patients with advanced ESCC who have failed first-line therapy. Eligible patients will receive Becotatug Vedotin combined with Tislelizumab and low-dose Lenvatinib. The primary endpoint is objective response rate (ORR) assessed per RECIST v1.1. Secondary endpoints include progression-free survival (PFS), disease control rate (DCR), duration of response (DOR), overall survival (OS), and safety.",[32],"2026-07-14",{"date":382,"type":43},{"date":433,"type":20},"2026-08-01",{"date":435,"type":20},"2029-12-31",{"name":437,"class":145},"Tianjin Medical University Cancer Institute and Hospital",{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":182,"enrollmentInfo":445,"targetDuration":4,"studyType":21,"phases":447,"briefSummary":448,"conditions":449,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":198},"100635574","phase-2-a-study-of-bl-b01d1-in-combination-with-tislelizumab-5-fluorouracil-versus-platinum-based-chemotherapy-plus-tislelizumab-as-first-line-treatment-in-patients-with-unresectable-locally-advanced-recurrent-or-metastatic-esophageal-squamous-cell-carcinomapanku-esophagus02-100635574","NCT07554456","A Study of BL-B01D1 in Combination With Tislelizumab ±5-Fluorouracil Versus Platinum-Based Chemotherapy Plus Tislelizumab as First-line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus02)","A Phase II\u002FIII Randomized Controlled Clinical Study of BL-B01D1 for Injection in Combination With Tislelizumab With or Without 5-Fluorouracil Versus Platinum-Based Chemotherapy Plus Tislelizumab as First-line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus02)","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to follow the protocol requirements;\n2. No gender restriction;\n3. Age ≥18 years and ≤75 years at the time of signing the informed consent form;\n4. Expected survival time ≥3 months;\n5. Patients with unresectable, locally advanced recurrent or metastatic first-line esophageal squamous cell carcinoma;\n6. Must have at least one measurable target lesion as defined by RECIST v1.1;\n7. Must provide archived tumor tissue specimens from the primary or metastatic lesion within the past 3 years;\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n9. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction; left ventricular ejection fraction ≥50%;\n11. Organ function levels must meet the specified requirements;\n12. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN);\n13. Urine protein ≤1+ or \\\u003C1000 mg\u002F24h;\n14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment; serum pregnancy test must be negative, and the patient must not be breastfeeding; all enrolled patients (regardless of male or female) must use adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Patients with esophageal squamous cell carcinoma whose pathology indicates the presence of non-squamous carcinoma components;\n2. Use of immunomodulatory drugs within 2 weeks prior to the first study drug administration;\n3. Prior use of an ADC drug whose small-molecule toxin is a topoisomerase I inhibitor;\n4. Patients with esophageal squamous cell carcinoma who are suitable for curative-intent local therapy;\n5. Receipt of curative-intent radiotherapy, major surgery, etc., within 4 weeks prior to study randomization;\n6. Ongoing long-term systemic corticosteroid therapy (e.g., \\>10 mg\u002Fday prednisone) prior to the first dose;\n7. Prior immunotherapy targeting PD-1, PD-L1, or PD-L2;\n8. History of severe heart disease or cerebrovascular disease;\n9. Prolonged QTc interval, complete left bundle branch block, etc.;\n10. Active autoimmune diseases and inflammatory diseases;\n11. Diagnosis of active malignant tumor within 3 years prior to study randomization;\n12. Hypertension poorly controlled by two antihypertensive agents;\n13. Patients with poorly controlled blood glucose;\n14. History of interstitial lung disease (ILD)\u002Finterstitial pneumonitis requiring steroid therapy, etc.;\n15. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;\n16. Presence of large serous cavity effusions or serous cavity effusions, etc.;\n17. Concomitant pulmonary diseases resulting in clinically severe respiratory function impairment;\n18. Imaging findings indicating tumor invasion or encasement of major blood vessels in the abdomen, thorax, neck, or pharynx;\n19. Tumor invasion or compression of the trachea or bronchi causing any clinical symptoms such as cough;\n20. Patients with esophageal fistula caused by tumor invasion of adjacent organs, or patients assessed by the investigator as being at risk of developing esophageal fistula;\n21. Patients with tracheal or esophageal stent placement due to any cause;\n22. Participants with clinically significant bleeding or an obvious bleeding tendency within 4 weeks prior to signing the informed consent form;\n23. BMI \\\u003C 18.5 kg\u002Fm² at screening, or weight loss ≥10% within 2 months prior to screening;\n24. Patients with active central nervous system metastases;\n25. Patients with a history of allergy to recombinant humanized antibodies or chimeric human-mouse antibodies, or allergy to any excipient component of BL-B01D1;\n26. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n27. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n28. Severe infection within 4 weeks prior to study randomization, etc.;\n29. History of severe neurological or psychiatric disorders;\n30. Patients with a history of substance abuse that precludes compliance with clinical trial requirements;\n31. Severe, non-healing wound, ulcer, or bone fracture within 4 weeks prior to signing informed consent;\n32. Patients with inflammatory bowel disease, history of extensive bowel resection, history of immune-mediated enteritis, intestinal obstruction, or chronic diarrhea, etc.;\n33. Receipt of other unapproved clinical study drugs or treatments within 4 weeks prior to study randomization;\n34. Trial participants planning to receive or having received live vaccine within 28 days prior to the first dose;\n35. Pregnant or breastfeeding women;\n36. Presence of other serious physical conditions, laboratory abnormalities, or poor compliance that may increase the risk of study participation, interfere with study results, or make the patient unsuitable for study participation in the investigator's opinion.",{"count":446,"type":20},90,[24,157],"This trial is a registrational Phase II\u002FIII, randomized, controlled, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with tislelizumab ± 5-FU in patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma.",[32],{"date":382,"type":43},{"date":452,"type":43},"2026-06-09",{"date":454,"type":20},"2028-12",{"name":456,"class":50},"Sichuan Baili Pharmaceutical Co., Ltd.",{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":16,"minAge":464,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":125,"phases":4,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":198},"100553739","predicting-postoperative-chemotherapy-efficacy-in-patients-with-esophageal-squamous-cell-carcinoma-100553739","NCT06490003","Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma","Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma by Biopsy Specimens.","Inclusion Criteria:\n\n1. Patients who had histologically confirmed esophageal squamous cell carcinoma.\n2. Patients who had undergone chemotherapy.\n3. Patients receiving initial chemotherapy\n4. Written informed consent following full study information is provided to the patient.\n\nExclusion Criteria:\n\n1. Patients for whom a preoperative biopsy sample cannot be obtained\n2. Patients who cannot assess at 2 months later after chemotherapy.\n3. Patients with multiple cancers.","20 Years",{"count":466,"type":20},150,"Esophageal cancer remains a disease with a poor prognosis. Chemotherapy is an important part of its treatment, but there are cases in which chemotherapy is ineffective. The investigators aim to develop a model to predict the response to chemotherapy by DNA methylation of preoperative biopsy specimens to identify the chemotherapy ineffective group.",[32,469,470],"Chemotherapy Effect","DNA Methylation","2026-07-10",{"date":473,"type":43},"2026-07-13",{"date":475,"type":43},"2004-06-01",{"date":477,"type":20},"2028-06-18",{"name":479,"class":145},"City of Hope Medical Center",{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":182,"enrollmentInfo":487,"targetDuration":4,"studyType":21,"phases":489,"briefSummary":490,"conditions":491,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":494,"completionDateStruct":495,"leadSponsor":496,"locationsCount":498},"100645753","phase-2-skb500-combinations-in-patients-with-esophageal-squamous-cell-carcinoma-100645753","NCT07700667","SKB500 Combinations in Patients With Esophageal Squamous Cell Carcinoma","A Phase II, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of SKB500 Combinations in Patients With Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Age ≥18 years and ≤75 years\n2. Histologically or cytologically confirmed unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC), who are ineligible for curative-intent therapies:\n\n   * Safety run-in phase (Cohort 1, 2 and 3): received no more than 1 prior line of systemic therapy for locally advanced or metastatic ESCC.\n   * Safety run-in phase (Cohort 4), randomized enrollment phase and cohort expansion phase: no prior systemic therapy for locally advanced or metastatic ESCC.\n3. Participants are required to provide tumor tissue samples for biomarker analysis.\n4. Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Life expectancy ≥ 12 weeks.\n\nExclusion Criteria:\n\n1. Histology or cytology confirms the presence of concurrent adenocarcinoma components.\n2. Leptomeningeal, brainstem, spinal, spinal cord compression, or active CNS metastases.\n3. Risk of esophagotracheal\u002Fesophagopleural fistula, or symptomatic invasion\u002Fcompression of vital organs\u002Fmajor blood vessels.\n4. Active autoimmune disease requiring systemic therapy within past 2 years.\n5. Weight loss ≥10% within 4 weeks prior to the first dose, or Nutritional Risk Index (NRI) \\\u003C 83.5.\n6. Severe infection within 4 weeks or active infection requiring systemic treatment within 2 weeks pre-dose.\n7. Uncontrolled comorbidities (e.g., decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, Grade ≥2 peripheral neuropathy).\n8. Cardiovascular\u002Fcerebrovascular events within 6 months pre-dose (e.g., Myocardial Infarction, unstable angina, acute\u002Fpersistent ischemia, Grade 3\u002F4 Heart Failure, symptomatic\u002Funcontrolled arrhythmia, Cerebrovascular Accident, Transient Ischemic Attack).\n9. Uncontrolled hypertension, diabetes, or recurrent pleural\u002Fpericardial\u002Fabdominal effusion requiring drainage.\n10. History of interstitial lung disease (ILD) or noninfectious pneumonitis that require steroid treatment, or currently has ILD\u002Fnoninfectious pneumonitis.\n11. Unresolved to grade ≤ 1 of prior anti-cancer treatment toxicities criteria per CTCAE v6.0.\n12. Previously received B7-H3-targeted agents, including antibody, antibodydrug conjugate (ADC), and other agents.\n13. Previously received treatment with an ADC that consists of a topoisomerase l inhibitor.\n14. Pregnant or lactating women.",{"count":488,"type":20},120,[24],"The purpose of this study is to evaluate the safety, tolerability and preliminary antitumor activity of SKB500 combinations in patients with Esophageal Squamous Cell Carcinoma. The study is divided into three parts: the safety run-in phase, randomized enrollment phase and cohort expansion phase.",[32],"2026-07-08",{"date":430,"type":43},{"date":188,"type":20},{"date":435,"type":20},{"name":497,"class":50},"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.",23,{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":182,"enrollmentInfo":506,"targetDuration":4,"studyType":21,"phases":508,"briefSummary":509,"conditions":510,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":198},"100645780","phase-2-neoadjuvant-cardonilizumab-combined-with-neoadjuvant-chemoradiotherapy-can-resect-locally-advanced-esophageal-squamous-cell-carcinoma-100645780","NCT07699185","Neoadjuvant Cardonilizumab Combined With Neoadjuvant Chemoradiotherapy Can Resect Locally Advanced Esophageal Squamous Cell Carcinoma","Neoadjuvant Cardonilizumab Combined With Chemotherapy Versus Neoadjuvant Concurrent Chemoradiotherapy in Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Multicenter, Open-label, Randomized, Controlled Study","Inclusion Criteria:\n\n* Sign a written informed consent before implementing any procedures related to the trial;\n* Male or female, 18 years old ≤75 years old;\n* Patients with histologically proven ESCC with a pathological stage of cT1N2M0 or cT2-3N0-2M0 according to AJCC Version 8 TNM stage and eligible for R0 surgical resection prior to treatment;\n* Have not received systematic treatment for the current disease, including surgical treatment, anti-tumor chemoradiotherapy\u002Fimmunotherapy, etc.;\n* Patients who agree to radical surgical treatment and are judged by the surgeon to have no surgical contraindications;\n* ECOG score 0-1;\n* Expected survival time \\>6 months;\n* For adequate organ function, subjects must meet the following laboratory criteria:\n* For adequate organ function, subjects must meet the following laboratory criteria:\n\n  1. The absolute value of neutrophil (ANC) ≥1.5x109\u002FL in the past 14 days without the use of granulocyte colony-stimulating factor;\n  2. Platelets ≥100×109\u002FL without blood transfusion in the past 14 days;\n  3. Hemoglobin \\>9g\u002FdL in the last 14 days without blood transfusion or use of erythropoietin;\n  4. Total bilirubin ≤1.5× upper limit of normal (ULN);\n  5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are ≤2.5×ULN\n  6. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml\u002Fmin;\n  7. Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;\n  8. Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;\n  9. The myocardial enzyme profile was within the normal range (if the researcher comprehensively judged that the simple laboratory abnormality was not clinically significant, it was also allowed to be included);\n* For female subjects of reproductive age, a urine or serum pregnancy test should be performed within 3 days prior to receiving the first study drug administration (day 1 of cycle 1) and the results are negative. If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy;\n* If there is a risk of conception, all subjects (male or female) are required to use contraception with an annual failure rate of less than 1% for the entire duration of treatment up to 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).\n\nExclusion Criteria:\n\n* Diagnosis of other malignant diseases (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and\u002For carcinoma in situ after radical resection) within 1.5 years;\n* Known endoscopic signs of active bleeding;\n* Is currently participating in an interventional clinical study, or has received other investigational drugs or used investigational devices within 4 weeks prior to initial dosing;\n* Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that respond to another stimulus or synergistic inhibition of T cell receptors (including but not limited to CTLA-4, OX-40, CD137, etc.);\n* Received systemic systemic treatment with Chinese patent drugs with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural fluid) within 2 weeks before the first administration;\n* An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to first administration. Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy;\n* Was receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal spray, inhalation, or other route) or any other form of immunosuppressive therapy within 7 days prior to the study's initial administration; Note: The use of physiological doses of glucocorticoids (≤10 mg\u002F day of prednisone or equivalent) is permitted;\n* Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n* Known allergy to the drugs used in this study;\n* Has not fully recovered from toxicity and\u002For complications caused by any intervention before starting treatment (i.e., ≤ grade 1 or baseline, excluding weakness or hair loss);\n* Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1\u002F2 antibody positive);\n* Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the study center); Note: Hepatitis B subjects who meet the following criteria can also be enrolled:\n\n  1. HBV viral load \\\u003C2500 copies \u002Fml (500 IU\u002Fml) prior to initial dosing, subjects should receive anti-HBV therapy throughout study chemotherapy therapy to avoid viral reactivation\n  2. For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required\n* Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection);\n* Received live vaccine within 30 days prior to the first dose (cycle 1, day 1);\n* Note: It is permissible to receive injectable inactivated virus vaccine against seasonal influenza within 30 days prior to initial administration; However, live attenuated influenza vaccines administered intranasally are not permitted\n* Pregnant or lactating women;\n* The presence of any serious or uncontrolled systemic disease, such as:\n\n  1. The resting electrocardiogram has major abnormal rhythm, conduction or morphology, such as complete left bundle branch block, heart block above Ⅱ degree, ventricular arrhythmia or atrial fibrillation;\n  2. Unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) grade ≥ 2 chronic heart failure;\n  3. Any arterial thrombosis, embolism or ischemia occurred within 6 months before treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack;\n  4. Poor blood pressure control (systolic \\> 140 mmHg, diastolic \\> 90 mmHg);\n  5. There is a history of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to first administration, or there is currently clinically active interstitial lung disease;\n  6. Active pulmonary tuberculosis;\n  7. There is an active or uncontrolled infection that requires systemic treatment;\n  8. Clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;\n  9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n  10. Poor diabetes control (fasting blood glucose (FBG) \\> 10mmol\u002FL);\n  11. Urine routine indicated urine protein ≥++, and confirmed 24-hour urine protein quantity \\> 1.0 g;\n  12. Patients with mental disorders who cannot cooperate with treatment; Evidence of medical history or disease that might interfere with the test results, prevent participants from fully participating in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment The Investigator considers other potential risks unsuitable for participation in the study.",{"count":507,"type":20},336,[24],"This is a multicenter, open-label, randomized, controlled clinical study to compare the efficacy and safety of cardonilizumab combined with neoadjuvant chemotherapy and surgery versus neoadjuvant chemoradiotherapy and surgery in locally advanced ESCC. Subjects were randomly divided into experimental group and control group, the experimental group received neoadjuvant immunotherapy concurrent chemotherapy regimen, the control group received neoadjuvant concurrent chemoradiotherapy regimen, and then received McKeown surgery. The primary outcome measures were complete pathological response (pCR), and the secondary outcome measures were major pathological response (MPR), EFS (event-free survival), OS (overall survival), overall response rate (ORR), decreased pathological stage, R0 resection rate, adverse events (AE), and perioperative complications",[32],"2026-07-07",{"date":473,"type":43},{"date":514,"type":43},"2024-01-29",{"date":516,"type":20},"2026-07-01",{"name":518,"class":145},"Tongji Hospital",{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":182,"enrollmentInfo":526,"targetDuration":4,"studyType":21,"phases":528,"briefSummary":529,"conditions":530,"keywords":531,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":537,"completionDateStruct":538,"leadSponsor":539,"locationsCount":198},"100646182","phase-1-becotatug-vedotin-plus-cisplatin-and-radiotherapy-in-la-escc-100646182","NCT07697040","Becotatug Vedotin Plus Cisplatin and Radiotherapy in LA-ESCC","A Phase Ib, Open-Label, Single-Arm Study of Becotatug Vedotin Combined With Cisplatin and Concurrent Radiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Subjects who are able to understand and voluntarily sign informed consent forms (ICFs).\n* Male and female subjects at the age of ≥18 and ≤75 at the time of screening.\n* Histologically confirmed esophageal squamous cell carcinoma staged as cT2-T4a, N0-N+, M0-M1 (M1 limited to supraclavicular lymph node metastasis only).\n* Patients must have at least one measurable lesion as defined by RECIST version 1.1 criteria.\n* Patients who have not received any prior anti-tumor treatment for esophageal cancer.\n* ECOG score of 0 or 1.\n* Life expectancy ≥ 3 months.\n* Adequate organ function (no blood transfusion and no use of granulocyte colony-stimulating factor, or other hematopoietic stimulator support within 2 weeks before the first administration of the study drug) confirmed as evidenced by:\n\n  1. Absolute Neutrophil Count (ANC) ≥ 1.5×10\\^9\u002FL;\n  2. Hemoglobin (Hgb) ≥ 90 g\u002Fdl;\n  3. Platelets (Plt) ≥ 75×10\\^9\u002FL;\n  4. Bilirubin total ≤ 1.5 x ULN, or bilirubin direct \\\u003C ULN for patients with bilirubin total levels \\>1.5 ULN;\n  5. AST\u002FALT ≤ 2.5 x ULN or ≤ 5.0 x ULN if liver metastases are present;\n  6. Serum creatinine \\\u003C 1.5 x ULN or creatinine clearance \\> 50 mL\u002Fmin (as calculated via Cockcroft-Gault formula based on the actual body weight of the subject ;\n* Female subjects must not be pregnant or breastfeeding. Female or male subjects of childbearing potential must agree to practice effective contraceptive measures throughout the study period and for 6 months after completion of study treatment.\n\nExclusion Criteria:\n\n* Diagnosis of any other malignancy within the past 5 years (excluding carcinoma in situ, basal cell carcinoma, etc.).\n* Anyone allergic to any drug or any of its components in this regimen.\n* Patients with a prior history of surgery for esophageal squamous cell carcinoma.\n* Patients with a prior history of fistula caused by primary tumor infiltration.\n* Patients at high risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation.\n* Subjects with poor nutritional status, defined as BMI \\\u003C 18.5 kg\u002Fm² or PG-SGA score ≥ 9.\n* Patients with a diagnosis of pulmonary fibrosis or interstitial pneumonia within 28 days prior to enrollment.\n* Active infections such as HIV; active chronic HBV\u002FHCV (e.g., HBV DNA ≥ 10⁴ copies\u002FmL or ≥ 2000 IU\u002FmL) requiring antiviral and hepatoprotective therapy before enrollment. Enrollment is allowed only when HBV DNA decreases to \\\u003C 10⁴ copies\u002FmL or \\\u003C 2000 IU\u002FmL, with continued antiviral therapy and regular monitoring of liver function and HBV DNA levels.\n* Presence of major cardiovascular disease, including any of the following conditions:\n\n  1. Congestive heart failure (defined as New York Heart Association \\[NYHA\\] Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stent implantation, coronary artery bypass grafting, cerebrovascular accident (CVA), or hypertensive crisis within 6 months prior to enrollment.\n  2. History of clinically significant ventricular arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes).\n  3. Fridericia-corrected QT interval (QTcF) \\> 450 msec in males or \\> 470 msec in females.\n  4. History or family history of congenital long QT syndrome.\n  5. Arrhythmias requiring antiarrhythmic therapy (subjects with atrial fibrillation that has been controlled for more than 30 days prior to randomization may be enrolled).\n  6. History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolic event within 3 months prior to enrollment (thrombosis related to an implanted venous access port or catheter, or superficial venous thrombosis, is not considered \"serious\" thromboembolism).\n* Severe chronic diarrhea.\n* Severe psychiatric disorder.\n* Use of strong inhibitors or inducers of CYP3A4, CYP2C8, and UGT1A1.\n* Participation in another clinical trial within 4 weeks prior to enrollment.\n* Patients who, in the opinion of the investigator, are unsuitable for participation in this study.",{"count":527,"type":20},12,[23],"This study is a prospective, single-arm, single-center Phase Ib clinical trial of Becotatug Vedotin in combination with cisplatin and concurrent radiotherapy for locally advanced esophageal squamous cell carcinoma. The primary objectives are to investigate the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and recommended Phase II dose (RP2D) of Becotatug Vedotin in combination with cisplatin and concurrent radiotherapy for locally advanced esophageal squamous cell carcinoma. The secondary objectives are to assess the efficacy and safety of this combination regimen.",[32],[532,533,534],"Becotatug vedotin (EGFR-ADC）","LA-ESCC","Cisplatin and Concurrent Radiotherapy","2026-07-06",{"date":471,"type":43},{"date":516,"type":20},{"date":435,"type":20},{"name":540,"class":145},"Hebei Medical University Fourth Hospital",{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":4,"eligibilityCriteria":547,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":548,"targetDuration":4,"studyType":21,"phases":550,"briefSummary":551,"conditions":552,"keywords":553,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":558,"completionDateStruct":559,"leadSponsor":561,"locationsCount":198},"100623938","phase-2-becotatug-vedotin--anti-pd-1-in-pretreated-advanced-escc-100623938","NCT07403136","Becotatug Vedotin ± Anti-PD-1 in Pretreated Advanced ESCC","An Open-Label, Randomized Phase II Study of Becotatug Vedotin With or Without PD-1 Inhibitor Immunotherapy in Patients With Advanced Esophageal Squamous Cell Carcinoma Refractory to Previous Immunochemotherapy","Inclusion Criteria:\n\n1. Willing to voluntarily sign the informed consent form and comply with the protocol requirements.\n2. Age ≥18 years on the day of signing the informed consent form, regardless of gender.\n3. Life expectancy ≥12 weeks.\n4. Patients with histologically confirmed advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC) and immunohistochemistry (IHC) confirmed positive epidermal growth factor receptor (EGFR) expression (IHC 1+, 2+, or 3+).\n5. Have experienced disease progression or intolerability after receiving at least one prior line of systemic therapy, which must have included an immune checkpoint inhibitor (e.g., anti-PD-1\u002FPD-L1 antibody).\n6. The patient must be able to provide a tumor tissue sample (paraffin block, paraffin-embedded sections, or fresh tissue sections) from the primary or metastatic site for pathological testing. Archived tumor tissue from the most recent treatment should be used. If archived tissue is unavailable, a new biopsy must be performed.\n7. Must have radiographic evidence of disease progression confirmed by the investigator during or after the last treatment regimen. At baseline, there must be at least one measurable extracranial lesion per RECIST 1.1 criteria (longest diameter ≥10 mm on CT scan, or for lymph nodes, short axis ≥15 mm). The measurable lesion should not have been previously irradiated, unless it is within a prior radiation field or was previously treated locally and has documented progression.\n8. All adverse events (AEs) from prior anti-tumor therapy have resolved to ≤ Grade 1 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 (except for alopecia, non-clinically significant or asymptomatic laboratory abnormalities).\n9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to the first dose.\n10. No serious cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50% confirmed by echocardiography or MUGA scan within 28 days prior to the first dose.\n11. Adequate organ function within 7 days prior to the first dose, as defined by:\n\n    * Bone marrow: Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL; platelet count ≥100 × 10⁹\u002FL; hemoglobin ≥90 g\u002FL. Patient must not have received any blood transfusion or blood component therapy within 14 days prior to the first dose, nor any biologic response modifiers (e.g., G-CSF, erythropoietin) within 7 days prior to the first dose.\n    * Liver: For patients without liver metastases: total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN. For patients with liver metastases: TBIL ≤1.5 × ULN; ALT and AST ≤5 × ULN.\n    * Kidney: Serum creatinine (Cr) ≤1.5 × ULN, or calculated creatinine clearance (Cockcroft-Gault formula) ≥50 mL\u002Fmin.\n    * Coagulation: International normalized ratio (INR) ≤1.5 × ULN and activated partial thromboplastin time (aPTT) ≤1.5 × ULN (unless the patient is receiving therapeutic anticoagulation).\n12. Male patients with reproductive potential and female patients of childbearing potential must be willing to use effective contraception from signing the ICF until 6 months after the last dose of the study drug. Women of childbearing potential include premenopausal women and women within 2 years of menopause onset. A negative serum pregnancy test result must be confirmed for women of childbearing potential within ≤7 days prior to the first study drug dose.\n\nExclusion Criteria:\n\n1. History of other primary malignancies. Note: Except for adequately treated basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; or patients with other malignancies who have undergone curative treatment and have been disease-free for ≥5 years may be enrolled.\n2. Untreated or unstable parenchymal brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.\n\n   Note: Patients who have received local therapy for brain metastases may be enrolled if brain imaging shows stability for at least 28 days prior to the first dose, with no evidence of cerebral edema, and no requirement for corticosteroid therapy.\n3. Presence of uncontrolled third-space fluid (e.g., significant ascites, pleural effusion, or pericardial effusion) that cannot be managed by drainage or other methods. Patients who required drainage to control third-space fluid within 14 days prior to the first dose are excluded.\n4. Any severe or uncontrolled systemic disease, in the investigator's judgment, including poorly controlled hypertension (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg), poorly controlled diabetes mellitus, or active bleeding signs, etc.\n5. Poorly controlled cardiac disease, including heart failure of New York Heart Association (NYHA) class ≥II, unstable angina, myocardial infarction within the past year, clinically significant supraventricular or ventricular arrhythmia requiring treatment, or long QT syndrome, e.g., QTcF \\>450 ms (male) or QTcF \\>470 ms (female).\n6. Evidence of active infection, including Hepatitis B (HBsAg positive AND HBV DNA ≥2000 IU\u002FmL, excluding drug-induced or other causes of hepatitis), Hepatitis C (anti-HCV antibody positive AND HCV RNA above the lower limit of detection), or human immunodeficiency virus (HIV) infection; or uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infections, unless treated and resolved prior to study drug administration.\n7. History of hypersensitivity to any component of vebrekotuzumab (histidine, histidine hydrochloride, sucrose, mannitol, polysorbate 80) OR history of ≥Grade 3 hypersensitivity reactions to macromolecular protein agents\u002Fmonoclonal antibodies.\n8. History of primary immunodeficiency or active autoimmune disease requiring systemic immunosuppressive therapy or systemic corticosteroid therapy (at doses ≥10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to enrollment.\n\n   Note: Patients with type I diabetes mellitus, hypothyroidism managed with stable hormone replacement therapy (including that caused by autoimmune thyroid disease), psoriasis not requiring systemic therapy, or vitiligo may be enrolled.\n9. History of or concurrent interstitial lung disease, radiation pneumonitis, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.\n10. Female patients who are pregnant (positive serum pregnancy test), breastfeeding, or unwilling to use adequate contraception during the study period and for 6 months after the last dose of study drug.\n11. Any other condition that, in the investigator's opinion, would make the patient unsuitable for participation in this clinical trial.",{"count":549,"type":20},104,[24],"This study will test a new potential treatment for advanced esophageal squamous cell cancer (ESCC) for patients whose initial treatment has stopped working. Currently, the standard second-line treatment for this cancer is PD-1 inhibitors or chemotherapy alone, which is not very effective, allowing the cancer to grow again after just 1.6 to 3.4 months on average. Therefore, there is a strong need for more effective therapies.\n\nThe new treatment is a type of drug called an antibody-drug conjugate (ADC). It is designed to target a specific protein called EGFR, which is found in high amounts on the surface of 50-70% of ESCC cancer cells and is linked to a poorer outlook for patients. This ADC works like a targeted delivery system: an antibody guides a powerful cell-killing drug directly to the cancer cells, aiming to destroy them while reducing harm to healthy cells. Although other drugs targeting EGFR have not successfully improved survival for ESCC patients, this new ADC offers a different and promising approach.\n\nThe main goal of this study is to find out if this new EGFR-targeting ADC is effective in helping patients with advanced ESCC live longer without their cancer getting worse.",[32],[32,554,555],"Antibody-drug conjugate","Second-line","2026-07-02",{"date":511,"type":43},{"date":217,"type":43},{"date":560,"type":20},"2029-01-31",{"name":562,"class":145},"Fudan University",{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":21,"phases":572,"briefSummary":573,"conditions":574,"keywords":583,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":593,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":599},"100392410","phase-1-a-study-of-sigvotatug-vedotin-in-advanced-solid-tumors-100392410","NCT04389632","A Study of Sigvotatug Vedotin in Advanced Solid Tumors","A Phase 1 Study of Sigvotatug Vedotin in Advanced Solid Tumors","Inclusion Criteria:\n\n* Disease indication\n\n  * Participants must have histologically or cytologically confirmed metastatic or unresectable solid malignancy within one of the tumor types listed below (dependent on study part).\n\n    * Non-small cell lung cancer (NSCLC)\n    * Head and neck squamous cell cancer (HNSCC)\n    * Advanced HER2-negative breast cancer\n    * Esophageal squamous cell carcinoma (ESCC)\n    * Esophageal\u002FGastro-esophageal junction adenocarcinoma (EAC\u002FGEJ)\n    * Cutaneous squamous cell cancer (cSCC)\n    * Exocrine pancreatic adenocarcinoma\n    * Bladder cancer\n    * Cervical cancer\n    * Gastric cancer\n    * High grade serous ovarian cancer (HGSOC)\n  * Part A only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies and should have no appropriate standard-of-care therapeutic options.\n  * Part B only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies. Participants must have received platinum-based therapy and a PD-1\u002FPD-(L)1 inhibitor, if applicable and available.\n  * Part C only: For pembrolizumab combination cohorts, participants must be eligible for pembrolizumab per local standard of care. For pembrolizumab with cisplatin or carboplatin, participants must be eligible for both pembrolizumab and the platinum agent per local standard of care. Participants must be treatment naïve for locally advanced or metastatic systemic therapy (prior definitively intended or \\[neo\\]adjuvant therapy is allowed).\n  * Part D only: Participants must be treatment naïve for locally advanced or metastatic systemic therapy.\n* Participants enrolled in the following study parts should have a tumor site accessible for biopsy and agree to biopsy as follows:\n\n  * Disease-specific expansion cohorts (Part B and Part D): A baseline fresh tumor biopsy is required. An archival biopsy collected within 90 days prior to first dose of study drug may be used.\n  * Biology expansion cohort: pretreatment biopsy and on-treatment (Cycle 1) biopsy\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Measurable disease per the RECIST v1.1 at baseline\n\nExclusion Criteria\n\n* History of another malignancy within 3 years before first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.\n* Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:\n\n  * are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment,\n  * have no new or enlarging brain metastases, and\n  * are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to first dose of study drug.\n  * In Part D, participants with untreated, asymptomatic CNS metastases smaller than 1 cm may be enrolled without definitive treatment as long as they have no neurological symptoms, no or minimal surrounding edema, and no requirements for corticosteroids.\n* Carcinomatous meningitis\n* Previous receipt of an MMAE-containing agent or an agent targeting integrin beta-6\n* Pre-existing neuropathy Grade 1 or greater per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) for Parts C and D cohorts with cisplatin or carboplatin; Grade 2 or greater per the NCI CTCAE v5.0 for all other cohorts\n* Any uncontrolled Grade 3 or higher (per NCI CTCAE v5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of sigvotatug vedotin.\n\n  * Routine antimicrobial prophylaxis is permitted\n* Grade ≥3 pulmonary disease unrelated to underlying malignancy. This includes clinically severe pulmonary function compromise resulting from clinically significant pulmonary illnesses\n* Part C and D: Prior therapy with a PD-1 inhibitor, anti-PD-(L)1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a Grade 3 or higher immune-mediated adverse event (IMAE).\n* History of noninfectious interstitial lung disease (ILD) or pneumonitis that required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that cannot be ruled out by imaging at screening\n* Known diffusing capacity of the lung for carbon monoxide (DLCO; adjusted for hemoglobin) \\\u003C50% predicted\n* Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.",{"count":571,"type":20},1006,[23],"This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors.\n\nThe study will have four parts.\n\n* Part A of the study will find out how much sigvotatug vedotin should be given to participants.\n* Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors.\n* Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs.\n* Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors.\n* In Parts C and D, participants will receive sigvotatug vedotin with either:\n\n  * Pembrolizumab or,\n  * Pembrolizumab and carboplatin, or\n  * Pembrolizumab and cisplatin.",[575,576,577,32,243,242,578,67,579,580,581,582],"Carcinoma, Non-Small Cell Lung","Squamous Cell Carcinoma of Head and Neck","HER2 Negative Breast Neoplasms","Ovarian Neoplasms","Exocrine Pancreatic Adenocarcinoma","Urinary Bladder Neoplasms","Uterine Cervical Neoplasms","Stomach Neoplasms",[254,256,584,585,586,587,588,589,590,591,592,241,64,34,292,300],"cSCC","ESCC","EAC","GEJ","HGSOC","Advanced HER2-Negative Breast Cancer","High Grade Serous Ovarian Cancer","Non-Small Cell Lung Cancer","Head and Neck Squamous Cell Cancer",{"date":535,"type":43},{"date":595,"type":43},"2020-06-08",{"date":597,"type":20},"2029-03-22",{"name":310,"class":50},158,{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":4,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":607,"targetDuration":4,"studyType":21,"phases":609,"briefSummary":610,"conditions":611,"keywords":613,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":113},"100573538","phase-1-a-study-to-investigate-alep02-as-monotherapy-in-adult-patients-with-selected-cldn1-solid-tumors-100573538","NCT06747585","A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors","A Phase I\u002FII, Open-Label, Multicenter Study of ALE.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+Squamous Solid Tumors","Inclusion Criteria:\n\n* Have disease and treatment history as: Have histologically or cytologically confirmed advanced locally recurrent and inoperable or metastatic SqNSCLC, HNSCC (nasopharyngeal cancer included), ESCC or CSCC.\n* Phase I Dose Escalation: Have received at least one systemic standard of care regimen and being refractory or intolerant to the treatment.\n* Phase I RDE and Phase II: Have received no more than 2 lines of systemic standard of care regimen and being refractory or intolerant to the treatment.\n* Have provided tissue for CLDN1 analysis in a central laboratory.\n* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.\n* Demonstrate adequate bone marrow and organ function.\n* Patients must have recovered from all toxicities led by prior treatment.\n* Have measurable disease based on RECIST 1.1 as determined by the site.\n\nExclusion Criteria:\n\n* Diagnosed with cancers of predominantly non-squamous histology (eg, adenosquamous carcinoma) or adenocarcinoma.\n* Has received antineoplastic therapies prior to study intervention within specified time frame.\n* Has rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain).\n* Patients with uncontrolled diabetes.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Has clinically significant gastrointestinal bleeding and has an active infection requiring systemic treatment and has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study, interfere with the patient's participation for the full duration of the clinical study, or is not in the best interest of the patient to participate.\n* Concomitant use of drugs that are known to prolong or shorten QT and\u002For have known risk of Torsades de Pointes.",{"count":608,"type":20},170,[23,24],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P02 monotherapy in adult patients with selected squamous solid tumors.",[612,31,71,32],"Squamous Non-small-cell Lung Cancer",[614,615,616,617,618],"Claudin-1 Targeted Antibody-Drug Conjugate","Monotherapy","First-in-Human","Recommended Phase 2 dose","Recommended dose for expansion","2026-06-26",{"date":621,"type":43},"2026-06-29",{"date":623,"type":43},"2024-12-16",{"date":625,"type":20},"2028-08-15",{"name":627,"class":50},"Alentis Therapeutics AG",{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":4,"eligibilityCriteria":634,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":635,"targetDuration":4,"studyType":21,"phases":637,"briefSummary":638,"conditions":639,"keywords":640,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":651,"locationsCount":652},"100463825","phase-1-a-study-to-evaluate-investigational-agents-with-or-without-pembrolizumab-mk-3475-in-participants-with-advanced-esophageal-cancer-previously-exposed-to-programmed-cell-death-1-protein-pd-1-programmed-cell-death-ligand-1-pd-l1-treatment-mk-3475-06b-100463825","NCT05319730","A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)\u002F Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)","A Phase 1\u002F2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and\u002For Chemotherapy in Participants With Advanced Esophageal Cancer Previously Exposed to PD-1\u002FPD-L1 Treatment (KEYMAKER-U06): Substudy 06B","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable esophageal squamous cell carcinoma (ESCC)\n* Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy, that includes a platinum agent and previous exposure to an anti-programmed cell death 1 (PD1)\u002Fprogrammed cell death ligand 1 (PD-L1) based immune oncology (IO) therapy\n* Has provided an archival or most recent tumor tissue sample obtained as part of clinical practice\n* Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible\n\nExclusion Criteria:\n\n* Direct invasion into adjacent organs such as the aorta or trachea\n* Has experienced weight loss \\>10% over approximately 2 months prior to first dose of study therapy\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that has undergone potentially curative therapy\n* Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Participants with human immunodeficiency virus (HIV) with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* History of allogenic tissue\u002Fsolid organ transplant\n* Clinically significant cardiovascular disease within 12 months from first dose of study intervention\n* Has risk for significant gastrointestinal (GI) bleeding such as a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation\u002Frandomization, significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation\u002Frandomization",{"count":636,"type":20},230,[23,24],"This is a Phase 1\u002F2, multicenter, randomized, open-label umbrella platform study to evaluate the safety and efficacy of investigational agents with or without pembrolizumab and\u002For chemotherapy, for the treatment of participants with second line (2L) esophageal squamous cell carcinoma (ESCC) who have previously been exposed to PD-1\u002FPD-L1 based treatment.",[32],[641,642,643,644],"Esophageal cancer","Programmed Cell Death 1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL-1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL-2, PD-L2)","2026-06-25",{"date":619,"type":43},{"date":648,"type":43},"2023-05-16",{"date":650,"type":20},"2029-04-10",{"name":112,"class":50},59,{"id":654,"slug":655,"hasResults":12,"nctId":656,"briefTitle":657,"officialTitle":657,"acronym":658,"eligibilityCriteria":659,"healthyVolunteers":319,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":660,"targetDuration":4,"studyType":21,"phases":662,"briefSummary":663,"conditions":664,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":679,"lastUpdatePostDateStruct":680,"startDateStruct":682,"completionDateStruct":683,"leadSponsor":685,"locationsCount":198},"100590778","evaluation-of-skin-tests-in-biotherapy-allergies-100590778","NCT06971848","Evaluation of Skin Tests in Biotherapy Allergies","ETCABIO","Inclusion Criteria :\n\n* Patient treated with one of the biotherapies under study (Atezolizumab 1200 mg, Nivolumab 480 mg, Obinutuzumab 100 mg, Durvalumab 1500 mg, Pembrolizumab 200 mg, Daratumumab 1800 mg, Cemiplimab 3500 mg) and who has received at least two injections of the biotherapy without suspected allergic side effects.\n* Subjects covered by or having the rights to medical care assurance\n* Written informed consent obtained from subject\n* If applicable, treatment with corticosteroids and H1 antihistamines by systemic route (IV or oral) which may be discontinued at least one week before performing the tests (Inhaled corticosteroids are allowed).\n\nExclusion Criteria:\n\n* Presence of local or diffuse dermatological lesions (e.g., psoriasis, eczema, ...) that could interfere with the interpretation of skin tests.\n* Poor understanding of the French language\n* Pregnancy, breastfeeding\n* Persons in detention by judicial or administrative decision\n* Person admitted to a health or social establishment for purposes other than research\n* Person subject to a legal protection measure",{"count":661,"type":20},70,[323],"Biotherapies are biological (extracted from an organism or living tissue) or biotechnological drugs used in the treatment of multiple conditions, such as autoimmune inflammatory diseases, cancers, and hematologic diseases. In recent years, these biotherapies have notably emerged in the treatment of cancers and hematologic disorders. As such, most patients with cancers or hematologic diseases will likely receive a biotherapy as part of their care pathway.\n\nThese biotherapies are associated with various side effects, including hypersensitivity or allergic reactions, which are often poorly characterized in clinical trials. These reactions manifest as symptoms without specific dermatologic or allergologic semiology (such as itching, erythema, shortness of breath, sometimes digestive issues, or discomfort, and in some cases, an anaphylactic reaction).\n\nUnlike other treatments, such as antibiotics and neuromuscular blockers, there are currently no guidelines on the concentrations to use in skin tests for biotherapies. We propose conducting prospective clinical research to scientifically establish the concentrations to be used when investigating hypersensitivity to a biotherapy, in line with best practice recommendations for drug skin testing.",[665,666,667,668,669,670,671,672,673,674,675,356,32,676,677,678],"Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck","Melanoma Neoplasms","Small Cell Bronchial Carcinomas","Bronchial Carcinoma","Pleural Mesothelioma","Hodgkin's Lymphoma","Chronic Lymphocytic Leukemia","Follicular Lymphoma","Myeloma","AL Amyloidosis","Hepatocarcinoma","Heart Cancer","Cholangiocarcinoma","Colorectal Adenocarcinoma","2026-06-17",{"date":681,"type":43},"2026-06-18",{"date":679,"type":43},{"date":684,"type":20},"2028-07",{"name":686,"class":197},"University Hospital, Angers",{"id":688,"slug":689,"hasResults":12,"nctId":690,"briefTitle":691,"officialTitle":692,"acronym":4,"eligibilityCriteria":693,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":694,"targetDuration":4,"studyType":21,"phases":695,"briefSummary":696,"conditions":697,"keywords":701,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":709,"startDateStruct":710,"completionDateStruct":712,"leadSponsor":714,"locationsCount":93},"100631678","phase-1-a-study-of-ide034-in-adult-participants-with-locally-advancedmetastatic-solid-tumors-types-100631678","NCT07503808","A Study of IDE034 in Adult Participants With Locally Advanced\u002FMetastatic Solid Tumors Types","An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE034 in Adult Participants With Locally Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Participant must be at least 18 years of age or the age of maturity per local regulations\n2. Participants with advanced recurrent or metastatic solid tumors expressing B7-H3 and PTK7 in the following indications: NSCLC, ESCC, endometrial cancer, HGSOC, HNSCC, TNBC (estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 \\[HER2\\] negative), CRC, and CRPC who have radiologically progressed or recurred on at least one line of therapy or is intolerant to additional effective standard therapies.\n3. Archival tissue sample for testing\n4. Measurable disease\n5. Have Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n6. Have adequate bone marrow and organ function.\n7. Able to comply with contraceptive\u002Fbarrier requirements\n\nExclusion Criteria:\n\n1. Known symptomatic brain metastases or leptomeningeal metastasis\n2. Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose.\n3. Have uncontrolled tumor-associated pain\n4. Have clinically significant cardiac abnormalities and\u002For cerebrovascular disease (stroke) within 6 months before the first dose\n5. Active uncontrolled infection\n6. Have history of interstitial pneumonitis, current noninfectious pneumonitis requiring steroid therapy; known or suspected interstitial pneumonitis as seen on screening imaging; other moderate to severe lung diseases seriously affecting respiratory function within 3 months before the first dose.\n7. Have history of severe infections within 4 weeks prior to the start of study treatment, including but not limited to bacteremia, severe pneumonia, or other serious infectious complications requiring hospitalization.\n8. Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test at screening.\n9. Participants with known or suspected viral hepatitis\n10. Have history of active tuberculosis within 1 year before enrollment\n11. If participants had adverse reactions to previous antitumor treatment that have not recovered to guidelines of CTCAE Grade ≤ 1 and Grade 2 peripheral neurological symptoms\n12. Have received chemotherapy within 3 weeks of first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 3 weeks before the first dose of IMP or other investigational products within 4 weeks of first dose of IMP\n13. Administration of any of the following\n\n    1. Current use or anticipated need for food or drugs that are known strong CYP3A4\u002F5 inhibitors or inducers\n    2. Have prior treatment with B7-H3 or PTK7 antibody-drug conjugate (ADC).\n    3. Have prior treatment with a topoisomerase I inhibitor (TOP1i), including an ADC with a TOP1i payload, within 6 months of first dose of IMP\n    4. Have received radiotherapy within 2 weeks prior to study entry\n    5. Have undergone major surgery or trauma within 4 weeks prior to study entry.\n    6. Have received live attenuated vaccine within 28 days prior to the first dose or are expected to receive live attenuated vaccine during the study treatment.\n    7. Female participants who are pregnant, lactating, or planning to become pregnant during the study period to 7 months after the last dose of IMP.\n    8. Are known to be allergic to any component or excipient of the IMP product or have a history of severe allergic reactions to other monoclonal antibody\u002Ffusion protein drugs.\n    9. Participants with complications in the eye including ulcers in the eye, and severe dry eye",{"count":466,"type":20},[23],"This is a Phase 1a\u002F1b, open-label, multicenter dose escalation and dose expansion clinical study to evaluate the safety, PK, immunogenicity and preliminary efficacy of IDE034 in participants with locally advanced\u002Fmetastatic solid tumor types that express B7-H3 and PTK7.",[32,590,31,356,698,699,700,297],"Castration-resistant Prostate Cancer","Non Small Cell Lung Cancer","Endometrium Cancer",[32,585,28,31,256,702,298,356,703,698,704,363,254,705,588,706,707,708],"Triple-negative Breast Cancer","CRC","CRPC","High-grade Serous Ovarian Cancer","Advanced, Metastic Solid Tumors","B7-H3 (CD276) and Protein Tyrosine Kinase 7 (PTK7)","IDE034",{"date":681,"type":43},{"date":711,"type":43},"2026-02-24",{"date":713,"type":20},"2027-07-30",{"name":715,"class":50},"IDEAYA Biosciences",{"id":717,"slug":718,"hasResults":12,"nctId":719,"briefTitle":720,"officialTitle":721,"acronym":722,"eligibilityCriteria":723,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":724,"targetDuration":4,"studyType":21,"phases":725,"briefSummary":726,"conditions":727,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":728,"lastUpdatePostDateStruct":729,"startDateStruct":730,"completionDateStruct":731,"leadSponsor":733,"locationsCount":4},"100642171","phase-2-precision-medicine-for-immunotherapy-resistant-advanced-esophageal-cancer-100642171","NCT07653451","Precision Medicine for Immunotherapy-Resistant Advanced Esophageal Cancer","Precision Medicine Strategies for Advanced Esophageal Cancer Refractory to Immune Checkpoint Inhibitors","ESCC-PT","Inclusion Criteria:\n\n1. Signed written informed consent from previous studies and age ≥18 years.\n2. Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC).\n3. Locally advanced, unresectable, or metastatic ESCC that progressed on or after standard second-line or later therapy containing immunotherapy (including but not limited to PD-1, PD-L1, CTLA-4 antibodies, or bispecific antibodies).\n4. At least one measurable lesion per RECIST 1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Anticipated life expectancy ≥12 weeks.\n7. Adequate organ and bone marrow function within 14 days prior to the first dose (without blood transfusion, EPO, G-CSF, or other hematologic supports), as defined by:\n\n   * Absolute neutrophil count (ANC) ≥1.5×109\u002FL\n   * Platelet count ≥100×109\u002FL\n   * Hemoglobin ≥9 g\u002FdL (or ≥5.6 mmol\u002FL)\n   * Serum albumin \\>30 g\u002FL\n   * Serum creatinine ≤1.5×ULN (Upper Limit of Normal) or calculated creatinine clearance ≥60 mL\u002Fmin (using the Cockcroft-Gault formula)\n   * Total bilirubin ≤1.5×ULN\n   * AST and ALT ≤2.5×ULN (≤5.0×ULN for patients with documented liver metastases, provided total bilirubin is within normal limits)\n   * International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5×ULN, and activated Partial Thromboplastin Time (aPTT) ≤1.5×ULN\n8. Female patients of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to the first dose. WOCBP and male patients with WOCBP partners must agree to use highly effective contraception from signing the informed consent throughout the treatment period and for at least 6 months after the last dose. (Highly effective methods include oral\u002Fimplanted hormonal contraceptives, intrauterine devices \\[IUDs\\], or barrier methods combined with spermicide. Postmenopausal women aged \\>50 years must have been amenorrheic for ≥12 months to be considered postmenopausal).\n9. Required washout periods prior to the first dose of study treatment are as follows:\n\n   * Systemic anticancer therapies (chemotherapy, targeted therapy, immunotherapy, biological therapy, or hormonal therapy) or participation in clinical trials: \\>4 weeks.\n   * Systemic small-molecule targeted therapies: \\>2 weeks or 5 half-lives (whichever is longer).\n   * Prior Chinese herbal medicine with anti-tumor activity: \\>2 weeks.\n   * Prior major surgery or radiotherapy: \\>4 weeks (palliative radiotherapy for bone metastases: \\>2 weeks).\n\nExclusion Criteria:\n\nExclusion Criteria\n\n1. Currently receiving concurrent antitumor therapies (including chemotherapy, systemic therapy, immunotherapy, radiotherapy, or surgery) at the time of enrollment.\n2. History of other malignancies within the past 3 years (except for cured thyroid cancer, cervical carcinoma in situ, basal\u002Fsquamous cell skin cancer, or other cured localized tumors with disease-free survival \\>3 years).\n3. Adverse events (AEs) from prior antitumor therapies that have not resolved to baseline or Grade ≤1 (excluding alopecia, Grade 2 anemia, or irreversible, clinically insignificant, asymptomatic laboratory abnormalities).\n4. Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose, or not fully recovered from surgical procedures; or plans for surgery during the study period.\n5. Active peripheral neuropathy (PN) or neurotoxicity ≥ Grade 2, history of Grade 3 neurotoxicity\u002FPN, or prior permanent discontinuation of treatment due to neurotoxicity\u002FPN.\n6. Active pneumonitis\u002Finterstitial lung disease (ILD), history of pulmonary radiation within 12 months prior to the first dose, or clinically significant underlying pulmonary disease (e.g., chronic obstructive pulmonary disease).\n7. Symptomatic or active central nervous system (CNS) metastases requiring intervention (including steroid therapy with prednisone \\>10 mg\u002Fday or equivalents, or anticonvulsants) within 4 weeks prior to the first dose.\n8. Any other severe underlying medical condition, including but not limited to: uncontrolled diabetes, active infections, vaccination within 4 weeks, active peptic ulcer, uncontrolled epilepsy, cerebrovascular accident within 6 months, gastrointestinal bleeding within 3 months, or clinical signs of coagulopathy.\n9. Clinically significant cardiovascular disease, including:\n\n   * Left ventricular ejection fraction (LVEF) ≤50% or below the institutional lower limit of normal (LLN) determined by echocardiography (ECHO) or MUGA scan (if ECHO is unavailable).\n   * Heart failure classified as NYHA Class ≥III.\n   * Uncontrolled hypertension (systolic BP ≥150 mmHg and\u002For diastolic BP ≥95 mmHg despite optimal medical therapy).\n   * Prior or current cardiomyopathy.\n   * Unstable angina, or myocardial infarction within 6 months.\n   * Serious arrhythmia requiring medical intervention (excluding controlled atrial fibrillation or paroxysmal supraventricular tachycardia).\n10. QTc interval ≥450 ms for males, or ≥470 ms for females (using Fridericia's formula), or history of congenital long QT syndrome.\n11. Dyspnea due to advanced malignancy complications or other diseases, requiring continuous supplemental oxygen therapy at rest.\n12. Any other severe psychiatric, psychological, familial, or geographical conditions that, in the investigator's opinion, could interfere with study compliance, protocol execution, follow-up, or place the patient at high risk of treatment-related complications.\n13. History of HIV infection or positive HIV serology.\n14. Active viral hepatitis B or C (Note: Patients with HBV are eligible if HBV DNA is within the normal range\u002Fsuppressed on antivirals; patients with positive HCV antibody are eligible if HCV RNA is undetectable via PCR). Frequent viral load monitoring is mandatory.\n15. History of life-threatening allergies, known hypersensitivity to any study drug components, recombinant proteins, or excipients, or intolerance to EGFR antibodies or eribulin.\n16. Pregnant or lactating women.\n17. Any concurrent medical condition that, in the investigator's clinical judgment, could compromise protocol compliance.",{"count":446,"type":20},[24,157],"This study is an open-label, biomarker-integrated umbrella trial designed to evaluate the clinical efficacy of molecular subtype- and genomic biomarker-guided precision therapies in patients with advanced esophageal cancer refractory to prior immunotherapy. Conducted in a two-step process, the study first enrolls patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have progressed on prior immunotherapy, performing circulating tumor DNA (ctDNA) sequencing to stratify them into three distinct treatment cohorts, after which patients receive tailored combination regimens matched to their specific molecular profiling in the second step. Specifically, Cohort 1 includes patients with high EGFR expression or activation of EGFR-related signaling pathways, who will receive Afatinib (40 mg, p.o., Q.D.) combined with Toripalimab (240 mg, i.v., Q21D) in a 21-day treatment cycle, continuing until radiographic disease progression (PD), unacceptable toxicity, loss to follow-up, death, or other investigator-determined criteria for discontinuation, with a maximum toripalimab treatment duration of 24 months. Cohort 2 comprises patients harboring genomic alterations directly associated with cell cycle regulation or activation of cell cycle signaling pathways, who will be treated with Dalpiciclib (125 mg, p.o., Q.D. for 21 consecutive days followed by a 7-day off period in a 28-day cycle \\[Q4W\\]) combined with Pyrotinib maleate (320 mg, p.o., Q.D., administered within 30 minutes post-meal, Q4W) until disease progression, unacceptable toxicity, initiation of a new anti-tumor therapy, withdrawal of consent, or investigator's decision for treatment discontinuation. Cohort 3 includes patients with other molecular profiles who do not fit Cohorts 1 or 2, who will receive Camrelizumab (200 mg, i.v., Q3W) and Apatinib (250 mg, p.o., Q.D.), with clinical efficacy evaluations performed every 6 weeks, continuing until radiographic PD, unacceptable toxicity, death, or treatment discontinuation, whichever occurs first. The study aims to recruit an estimated maximum of 90 subjects, enrolling up to 30 subjects per cohort, with the final sample size dependent on the observed toxicities and the prevalence of each molecular cohort within the screened population.",[32],"2026-06-12",{"date":679,"type":43},{"date":516,"type":20},{"date":732,"type":20},"2028-12-31",{"name":734,"class":145},"Peking University Cancer Hospital & Institute"]