[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"interventionName\":\"Immunotherapy\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":649},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,46,0,25,[9,42,65,92,114,142,178,200,236,269,290,311,334,361,386,413,434,455,474,497,525,547,568,599,625],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100408110","nodal-radiation-therapy-for-sentinel-lymph-node-positive-melanoma-100408110",false,"NCT04594187","Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma","The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma","MelPORT","Inclusion Criteria:\n\n* Must be planned for post-operative immunotherapy\n* No evidence of distant metastasis as determined by clinical examination and any form of imaging\n* No evidence of clinically involved lymph nodes prior to SLNB\n* Pathologically confirmed sentinel lymph node positive melanoma with high risk features (extracapsular extension \\[ECE\\] or 0.5 mm+ nodal tumor implant or 2+ involved nodes or lymphovascular invasion of the primary tumor)\n* Has provided written informed consent for participation in this trial\n* Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less\n* Life expectancy greater than 6 months\n* Patients capable of childbearing are using adequate contraception\n* Available for follow-up\n\nExclusion Criteria:\n\n* Complete lymph node dissection (CLND) of the nodal basin containing the positive SLN\n* Distant metastasis\n* Previous radiation therapy (RT) to the nodal area planned for RT such that the prior RT field would be included in the current treatment field. In other words, treatment on this trial would require re-irradiation of tissues\n* Women who are pregnant\n* Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from this study","ALL","18 Years",{"count":21,"type":22},168,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This phase II trial seeks to determine the role of nodal radiation therapy after sentinel lymph node biopsy (SLNB) for patients with high risk sentinel lymph node positive melanoma who are planned for immunotherapy without completion lymph node dissection. Prior studies of patients with more advanced melanoma have shown nodal radiation therapy can decrease the risk of nodal recurrence but it is not known if this same benefit will be seen in patients with high risk sentinel lymph node positive disease who are planned for immunotherapy.",[28],"Melanoma","RECRUITING","2026-08-07",{"date":32,"type":33},"2026-08-10","ACTUAL",{"date":35,"type":33},"2020-08-07",{"date":37,"type":22},"2027-12-31",{"name":39,"class":40},"M.D. Anderson Cancer Center","OTHER",3,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100615487","phase-2-a-study-of-targeted-post-surgery-radiation-therapy-for-non-small-cell-lung-cancer-with-remaining-lymph-node-cancer-after-treatment-100615487","NCT07293247","A Study of Targeted Post-Surgery Radiation Therapy for Non-Small Cell Lung Cancer With Remaining Lymph Node Cancer After Treatment","Involved-Station, Intensity-Modulated Post-Operative Radiation Therapy (I²-PORT) for Resected Non-Small Cell Lung Cancer With Residual Mediastinal Adenopathy After Neoadjuvant Therapy (ypN2)","* Histopathologic diagnosis of NSCLC, may have mixed or multiple histologies but no small cell component\n* No known EGFR mutation or ALK rearrangement\n* No metastatic disease (M0) per most recent PET\u002FCT and head CT\u002FMRI imaging\n* No disease progression per CT chest (including upper abdomen as per standard practice) with intravenous (IV) contrast (unless IV contrast is contraindicated) or FDG-PET performed post-neoadjuvant therapy ≤ 90 days prior to registration, either before or after surgery\n* No metastatic disease (M0) per head CT\u002FMRI imaging\n* Prior treatment with 2-4 cycles of neoadjuvant systemic therapy with any guideline (National Comprehensive Cancer Network \\[NCCN\\]) concordant regimen\n* Lobectomy or greater oncologic surgical resection within 8 weeks prior to registration\n* Complete (R0) resection showing ypN2 disease\n* No prior radiotherapy to the lungs or mediastinum\n* No treatment with a VEGF inhibitor ≤ 90 days prior to registration or plan to treat with adjuvant systemic therapy including a VEGF inhibitor\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n* Platelet count ≥ 50,000\u002Fmm\\^3\n* Calculated (Calc.) creatinine clearance ≥ 30 mL\u002Fmin\n* Total bilirubin ≤ 3 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 5 x upper limit of normal (ULN)\n* Not pregnant, because this study involves radiation therapy, which has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to registration is required\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Cardiac function: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* No idiopathic pulmonary fibrosis requiring anti-fibrotic medication: Patients with idiopathic pulmonary fibrosis or inflammatory\u002Finterstitial lung disease compromising pulmonary function or requiring ongoing treatment with nintedanib, pirfenidone, or other anti-fibrotic drug are excluded\n* HIV-infected patients on effective anti-retroviral therapy with an undetectable viral load within 6 months are eligible for this trial",{"count":50,"type":22},164,[25],"This phase II trial compares the effect of intensity-modulated post-operative radiation therapy (I²-PORT) followed by standard of care therapy (chemotherapy or immunotherapy) to standard of care therapy alone in treating patients with non-small cell lung cancer (NSCLC) who have remaining lymph node cancer after surgery. Radiation therapy uses high-energy X-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Intensity-modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Adding I²-PORT radiation therapy to standard therapy may be more effective than standard therapy alone in reducing the risk of cancer returning in those who have undergone surgery for NSCLC.",[54],"Lung Non-Small Cell Carcinoma","2026-08-04",{"date":57,"type":33},"2026-08-05",{"date":59,"type":22},"2026-07-14",{"date":61,"type":22},"2032-03-01",{"name":63,"class":40},"Alliance for Clinical Trials in Oncology",74,{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100374167","petct-changes-during-chemoimmunotherapy-and-radiation-therapy-in-patients-with-stage-iv-non-small-cell-lung-cancer-100374167","NCT04151940","PET\u002FCT Changes During Chemoimmunotherapy and Radiation Therapy in Patients With Stage IV Non-small Cell Lung Cancer","An Interventional Study of PET\u002FCT Changes During Chemoimmunotherapy and Radiation Therapy for Patients With Metastatic NSCLC (PET Bright)","Inclusion Criteria:\n\n* Histologically-confirmed or cytologically-confirmed metastatic NSCLC in patients who have not received chemotherapy or immunotherapy for their advanced disease (stage IV or recurrent, using the American Joint Committee on Cancer \\[AJCC\\]\u002FUnion for International Cancer Control \\[UICC\\] 8th edition for staging)\n* Evidence of stage IV disease on imaging by CT, PET\u002FCT, or magnetic resonance imaging (MRI)\n* Plan to treat with a platinum doublet with a PD1 or PDL1 inhibitor\n* Adjuvant chemotherapy or concurrent chemoradiation for early stage disease does not count as prior therapy unless subject progressed within 6 months of completion of regimen.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, at treating physician's discretion\n* Subjects must be ≥ 18 years of age\n* Patients with known activating mutations in EGFR, BRAF or known translocation in ALK or ROS-1 are eligible provided they have progressed on or were intolerant to Food and Drug Administration (FDA) approved targeted therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2\n* Creatinine =\\\u003C 2 mg\u002FdL or creatinine clearance \\> 50 mL\u002Fmin\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 5x institutional upper limit of normal\n* Total bilirubin =\\\u003C 1.5 mg\u002FdL\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL (\\>= 1500 per mm\\^3)\n* Platelet count \\>= 100 x 10\\^9\u002FL (\\>=100,000 per mm\\^3)\n* Capability to understand and comply with the protocol requirements and signed informed consent documents\n\nExclusion Criteria:\n\n* Any known additional malignancy (with exception of non-melanoma skin cancer, in-situ breast cancer, low risk prostate cancer, or a malignancy diagnosed \\>= 3 years prior to the current NSCLC diagnosis and with no evidence of requiring active treatment)\n* Had prior treatment with an anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms\n* Has any serious or uncontrolled active infection that could create false positives on a PET\u002FCT scan, in the opinion of the treating investigator\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n* Has an active autoimmune disease currently requiring systemic treatment (e.g. disease modifying agents, corticosteroids or immunosuppressive drugs)\n\n  \\*\\*Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Has known, active, and symptomatic central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n\n  * Patients with stable or previously treated brain metastases are eligible as long as they are not receiving more than 10 mg of prednisone, or equivalent, per day",{"count":73,"type":22},80,[75],"NA","This study investigates the changes in positron emission tomography (PET)\u002Fcomputed tomography (CT) imaging scans during chemoimmunotherapy and radiation therapy treatment in patients with stage IV non-small cell lung cancer. Analyzing changes in PET\u002FCT imaging scans may help doctors assess and predict patterns of cancer response to chemoimmunotherapy and radiation therapy.",[78,79,80],"Metastatic Lung Non-Small Cell Carcinoma","Recurrent Lung Non-Small Cell Carcinoma","Stage IV Lung Cancer AJCC v8",[82],"Lung",{"date":84,"type":33},"2026-08-06",{"date":86,"type":33},"2019-09-26",{"date":88,"type":22},"2027-11-30",{"name":90,"class":40},"University of Washington",1,{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":41},"100547617","cardiopulmonary-monitoring-in-lung-cancer-patients-receiving-combined-thoracic-radiotherapy-and-immunotherapy-100547617","NCT06410300","Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy","A Multi-Center Pilot Biomarker Study With Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy","Inclusion Criteria:\n\n* Patient older than 18 years age\n* Diagnosis of locally advanced lung cancer (NSCLC or SCLC) with planned curative radiotherapy (45Gy and above) and planned consolidation immunotherapy.\n\n  * Patients who are not receiving concurrent chemotherapy and radiotherapy are eligible.\n  * Patients on a clinical trial that includes thoracic radiotherapy and immunotherapy are eligible and may be co-enrolled to this study.\n* ECOG performance status of 0-2\n* Life expectancy of 6 months or longer\n* Patient able to provide a written informed consent prior to study entry\n\nExclusion Criteria:\n\n* Prior thoracic radiotherapy to chest.\n* Patients are excluded if they are not candidates for curative thoracic radiotherapy or immunotherapy.\n* Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study.",{"count":100,"type":22},125,"OBSERVATIONAL","The overall purpose of this study is to evaluate cardiopulmonary toxicity in patients with lung cancer (NSCLC or SCLC) undergoing combined thoracic radiotherapy ± chemotherapy and immunotherapy through timed monitoring and blood sample collection and to identify correlative biomarkers for predicting cardiopulmonary adverse events.",[104],"Lung Cancer","2026-07-28",{"date":107,"type":33},"2026-07-30",{"date":109,"type":33},"2024-04-19",{"date":111,"type":22},"2030-04-19",{"name":113,"class":40},"Bo Lu",{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":141},"100564316","impact-of-physical-activity-on-immunotherapy-induced-toxicities-in-melanoma-management-100564316","NCT06627595","Impact of Physical Activity on Immunotherapy-induced Toxicities in Melanoma Management","APiTOXMM","Inclusion Criteria:\n\n* age 18 years or above\n* ECOG performance status inferior or equal to 3\n* patient with a melanoma confirmed histologically\u002Fpathologically\n* indication for initiating treatment with anti-PD1 immunotherapy or anti-PD1 + anti-CTLA4\n\nExclusion Criteria:\n\n* patient unable to read and\u002For write\n* inability to follow up with the patient during the study period\n* refusal to participate after a reflection period\n* medical contraindication to initiating immunotherapy (active autoimmune disease requiring systemic treatment in the past 2 years, active infection, etc.)\n* not affiliated with a social security system\n* patient under legal protection, guardianship, or curatorship\n* person participating in another study that includes an ongoing exclusion period",{"count":122,"type":22},160,"Management of melanoma is based on primary excision of the tumor. In cases of melanoma with poor prognosis criteria, or when it is locally advanced or metastatic, there is an indication for the implementation of adjuvant therapy, which may, in this context, be immunotherapy.\n\nImmunotherapies are treatments that have revolutionized the prognosis of patients with melanoma. These are therapies that work by stimulating the immune system to enhance the anti-tumor response. Their toxicities are represented by immune-mediated toxicities, similar to true autoimmune diseases.\n\nAdapted physical activity as supportive care in oncology is expanding. From a pathophysiological perspective, physical activity is thought to modulate the immune system (by reducing inflammation, restoring immune surveillance, stimulating anti-tumor responses through the induction of T cell proliferation, modulating the gut microbiota, and influencing tumor microenvironment cells, etc.).\n\nThe modulation of the immune system by physical activity may also allow us to hypothesize a modulation of the toxicities induced by immune checkpoint inhibitors. We wish to study this hypothesis in patients with advanced melanoma who are candidates for immunotherapy.\n\nOriginality and Innovative Aspects:\n\nPhysical activity as supportive care in oncology has developed significantly in recent years. However, adapted physical activity (APA) is currently only offered at one center in France (CHU de Lille).\n\nIn addition to the probable impact on patients\\' quality of life, if we find evidence supporting a reduction in treatment-related toxicities for melanoma through physical activity, it would be even more interesting to introduce APA at the CHU of Montpellier.\n\nPrimary and Secondary Objectives:\n\nPrimary Objective: To analyze the association between the level of physical activity (estimated by the IPAQ questionnaire) at the initiation of immunotherapy and the occurrence of adverse effects at 6 months after starting treatment in adult patients with melanoma.\n\nSecondary Objectives:\n\nAnalyze the association between physical activity level and treatment efficacy of immunotherapy in adult melanoma patients.\n\nDescribe the quarterly evolution of patients\\' general condition through measurement of WHO status and BMI.\n\nAssess the evolution of patients\\' general condition: WHO status and BMI at treatment introduction, after 3 months, and at 6 months of treatment.\n\nStudy the evolution of patients\\' quality of life during their treatment based on their physical activity level, using the QLQ-C30 questionnaire.\n\nPreliminary study:\n\nWe aim to evaluate the correlation between self-reported physical activity by patients and their actual physical activity. To obtain an objective measurement of patients\\' physical activity level, we plan to work with the CARTIGEN platform and offer a small number of included patients (maximum of 50) to wear wrist actimeters for one week before treatment initiation. We will then analyze these data to determine patients\\' baseline physical activity levels and compare them with the data collected via questionnaires.\n\nThis is a prospective cohort study within the context of analytical epidemiological research. It is a bicentric study: CHRU Montpellier - Saint-Eloi Hospital and ICM Val d\\'Aurelle.\n\nUsing the collected data on patients\\' physical activity levels (IPAQ questionnaire), we will compare two groups: patients who experienced immuno-toxicities without physical activity versus those with moderate or high physical activity.\n\nWe will also analyze treatment efficacy in these two groups, patients\\' quality of life, and the evolution of their general condition.\n\nProcedure:\n\nInclusion is planned at day 0 (D0), with physical activity (IPAQ3) and quality of life (QLQ-C30) questionnaires, along with clinical and oncological evaluation.\n\nA follow-up visit at month 3 (M3) will include reassessment of clinical and oncological status, followed by another visit at month 6 (M6) for further clinical, oncological, physical activity, and quality of life reassessment.\n\nThe inclusion period is expected to last 18 months.\n\nOutcomes \u002F Perspectives:\n\nIf we consider that physical exercise may help mitigate the toxic effects of treatments-an aspect we wish to explore through this project-it would be relevant to introduce adapted physical activity (APA) sessions supervised by a specialized instructor within the Dermatology Day Hospital at the CHU of Montpellier.\n\nImplementing APA in the context of onco-dermatology will strengthen the multidisciplinary approach of the CHU.\n\nCollaboration between healthcare professionals, including specialized APA instructors, will foster effective care coordination.\n\nThis initiative is part of a holistic approach to patient care, integrating complementary interventions to address physical, psychological, and social needs.",[28,125],"Immunotoxicity",[127,128,129,130,131,132],"physical activity","melanoma","immunotherapy","anti-PD-1","anti-CTLA4","immunotoxicity","2026-07-27",{"date":105,"type":33},{"date":136,"type":33},"2024-11-05",{"date":138,"type":22},"2028-05-05",{"name":140,"class":40},"University Hospital, Montpellier",2,{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":23,"phases":151,"briefSummary":153,"conditions":154,"keywords":162,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":177},"100590952","phase-1-study-of-orally-administered-moma-341-in-participants-with-advanced-or-metastatic-solid-tumors-100590952","NCT06974110","Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors","A Phase 1 Study of MOMA-341 as Monotherapy or Combination Therapy in Participants With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Participants have unresectable advanced or metastatic solid tumors with MSI-H or dMMR alterations and histologically confirmed disease. Participants must have previously received and progressed on an anti-PD-(L)1-based regimen, unless ineligible or in a region without access to anti-PD-(L)1 therapies\n3. Have at least 1 lesion at baseline (measurable or non-measurable) suitable for repeat imaging evaluation by RECIST and\u002For PCWG-3\n4. ECOG PS ≤ 2\n5. Fully recovered from clinically relevant effects of prior therapy, radiotherapy, and\u002For surgery \\*\\*hormonal therapy allowed. Palliative radiotherapy allowed\n6. Adequate organ function per local labs\n7. Comply with contraception requirements\n8. Written informed consent must be obtained according to local guidelines\n\nExclusion Criteria:\n\n1. Known Werner Syndrome\n2. Active prior or concurrent advanced-stage malignancy (some exceptions allowed including early-stage cancers)\n3. Clinically relevant cardiovascular disease\n4. Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed)\n5. Known active uncontrolled infection\n6. Known allergy, hypersensitivity, and\u002For intolerance to MOMA-341\n7. Impaired GI function that may impact absorption\n8. Patient is pregnant or breastfeeding\n9. Known to be HIV positive, unless all of the following criteria are met:\n\n   1. Undetectable viral load or CD4+ count ≥300 cells\u002FμL\n   2. Receiving highly active antiretroviral therapy\n   3. No AIDS-related illness within the past 12 months\n10. Active liver disease (some exceptions are allowed)\n11. Prior or ongoing condition, therapy, or laboratory abnormality that, in the investigator's opinion, may affect safety of the patient, confound the results of the study, and\u002For interfere with the patients participation in the study",{"count":150,"type":22},132,[152],"PHASE1","This Phase 1, multi-center, open-label, dose escalation and dose optimization study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and preliminary clinical activity of MOMA-341 administered orally as a single agent or combination therapy in patients with microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) solid tumors.",[155,156,157,158,159,160,161],"Advanced Solid Tumor","Metastatic Solid Tumor","Endometrial Cancer","MSI-H Cancer","Colorectal Cancer","Gastric Cancer","dMMR Cancer",[163,164,165,166,155,156,160,159,157,158,161],"Phase 1","MOMA-341","Werner helicase","WRN","2026-07-22",{"date":169,"type":33},"2026-07-23",{"date":171,"type":33},"2025-07-16",{"date":173,"type":22},"2028-05",{"name":175,"class":176},"MOMA Therapeutics","INDUSTRY",15,{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":23,"phases":187,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":91},"100526137","phase-1-immune-response-activation-for-the-treatment-of-unresectable-metastatic-colorectal-cancer-or-cea-positive-metastatic-breast-cancer-100526137","NCT06130826","Immune Response Activation for the Treatment of Unresectable Metastatic Colorectal Cancer or CEA Positive Metastatic Breast Cancer","A Phase I Study of M5A-IL2 Immunocytokine Combined With Stereotactic Body Radiation Therapy (SBRT) in Patients With Metastatic Colorectal Cancer or CEA-Positive Metastatic Breast Cancer","Inclusion Criteria:\n\n* Patients should have a diagnosis of metastatic colon or rectal or breast cancer that is pathology proven\n* Patients should have a CEA producing colorectal cancer or breast cancer defined as a baseline CEA or prior documented CEA level exceeding 5 ng\u002Fml or evidence of CEA staining by Immunohistochemistry (IHC)\n* Patients should 18 years of age or older\n* Patients are willing and capable to consent to study and to adhere with all elements of the study\n* Patients who have failed to respond to standard systemic therapy, or for whom standard or curative systemic therapy does not exist, is not tolerable or was refused\n* Patients should be at least 4 weeks from last receipt of a cytotoxic or biological agent prior to start of SBRT, with the exception of mitomycin C which requires a 6-week washout\n* Patients should have unresectable disease or not be a candidate for surgical resection\n* Patients must have a minimum of 1 and a maximum of 5 separate metastatic lesions planned for SBRT. (Patients may have \\> 5 metastatic lesions overall, however only up to 5 lesions will be treated with SBRT.) SBRT sites must be equal to or less than 5 cm in greatest dimension. SBRT treated sites must be measurable per RECIST 1.1 and can include metastatic sites in the lung, liver, or soft tissue. Sites that are intracranial or in the bone are excluded. Sites deemed not appropriate for SBRT by the treating radiation oncologist are also excluded\n* Patients should be at least 4 weeks from last radiation therapy prior to starting SBRT\n* Patients should be at least 4 weeks from any investigational therapy prior to starting SBRT, with the exception of prior immunotherapy which would require a 3 month washout\n* Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Patients should be considered clinically stable with an estimated overall survival of at least 3 months\n* Neutrophil count \\> 1500\u002Fmm\\^3\n* Lymphocyte count \\> 500\u002Fmm\\^3\n* Hemoglobin \\> 9 gm\u002Fdl\n* Platelets count \\> 100,000\u002Fmm\\^3\n* Aspartate transaminase (AST)\u002Falanine transaminase (ALT) \\\u003C 2.5 x upper limit of normal (ULN)\n* Bilirubin ≤ ULN\n* Patients should have adequate kidney function defined as a serum creatinine \\\u003C ULN or calculated creatinine clearance of \\> 60ml\u002Fmin (Cockroft-Gault formula)\n* Patients should have adequate cardiac function defined as:\n\n  * No history of acute coronary syndromes (including myocardial infarction, unstable angina, Coronary artery bypass grafting (CABG), coronary angioplasty, or stenting) \\\u003C 12 months prior to screening\n  * No impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:\n\n    * Symptomatic chronic heart failure;\n    * Evidence of clinically significant cardiac arrhythmias and\u002For conduction abnormalities\n  * No uncontrolled arterial hypertension despite appropriate medical therapy (defined as systolic blood pressure \\> 160 or diastolic blood pressure \\>100)\n  * Electrocardiogram (EKG) showing normal sinus rhythm and a corrected QT (QTc) ≤ 450 ms for male and ≤ 470 ms for female patients\n* Patients should have adequate pulmonary function defined as:\n\n  * Lack of uncontrolled pleural effusion requiring recurrent draining procedures (more than once per month)\n  * Lack of oxygen supplementation dependence\n* All subjects must have the ability to understand and the willingness to sign a written informed consent\n* Screening 2-dimensional (2-D) echocardiogram (echo) shows a left ventricular ejection fraction (LVEF) \\> 40%\n* Urinalysis shows lack of proteinuria or a maximum of 1+ proteinuria\n* Women of childbearing potential should use highly effective contraception while receiving the trial regimen and for at least 5 half-lives of M5A-IL2 from the last dose of M5A-IL2\n\nExclusion Criteria:\n\n* Patients on immunosuppressive treatments including supra-physiological doses of corticosteroids\n* Patients with history of auto-immune disease including history of inflammatory bowel disease\n* Patients with active brain metastases\n* Patients in the child-bearing ages who refuse to use adequate birth control measures (example: contraceptives, barrier method, or abstinence)\n* Lactating females who do not agree to stop breastfeeding\n* Known active hepatitis B or C\n* Major surgical procedure within 4 weeks prior to SBRT\n* Non-healed wound or surgical incisions\n* Radiographic evidence of bowel obstruction\n* Electrolyte disturbances (sodium, potassium, magnesium, calcium, and phosphorous) that are not correctable to at least CTCAE grade 1 with replacement therapy\n* Known hypersensitivity of any of the study drug agents or components\n* Patients should not have any uncontrolled illness including ongoing or active infection\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents\n* Pregnant women are excluded from this study because the investigational agents on this study are highly likely to exert teratogenic or abortifacient effects\n* Patients with other active malignancies are ineligible for this study\n* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study",{"count":186,"type":22},24,[152],"This phase I trial studies the side effects and best dose of M5A-IL2 immunocytokine (M5A-ICK) combined with stereotactic body radiation therapy (SBRT) and to see how well they work in treating patients with colorectal cancer or xarcinoembryonic antigen (CEA) positive breast cancer that cannot be removed by surgery (unresectable) or has spread from where it first started (primary site) to other places in the body (metastatic). Carcinoembryonic Antigen (CEA) is a protein that is present in most colorectal cancers and in many other cancers, such as breast cancer, as well. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Cytokines are signaling proteins that help control inflammation in the body. They allow the immune system to mount a defense if germs or cancer or other substances that can make people sick enter the body. Interleukin-2 (IL-2) is a powerful cytokine able to regulate the immune responses that are important for anticancer immunity. Immunocytokines (also called antibody-cytokine fusion proteins) are small proteins that regulate the activity of immune cells. The M5A-IL2 immunocytokine (M5A-ICK) combines the cancer targeting features of the M5A antibody with the immune system regulation properties of the cytokine IL-2. Giving M5A-ICK in combination with standard of care (SOC) SBRT may work better in treating patients with unresectable metastatic colorectal cancer or CEA positive metastatic breast cancer.",[190,191],"Breast Carcinoma","Colorectal Carcinoma","2026-07-20",{"date":167,"type":33},{"date":195,"type":33},"2025-05-27",{"date":197,"type":22},"2026-09-05",{"name":199,"class":40},"City of Hope Medical Center",{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":212,"conditions":213,"keywords":219,"overallStatus":226,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":91},"100646291","phase-2-shuganhuazhuo-formula-for-advanced-hepatocellular-carcinoma-with-damp-heat-syndrome-100646291","NCT07691645","Shuganhuazhuo Formula for Advanced Hepatocellular Carcinoma With Damp-Heat Syndrome","Shuganhuazhuo Formula (Chinese Herbal Medicine) in the Combined Treatment of Advanced Hepatocellular Carcinoma With Damp-Heat and Blood Stasis Syndrome: An Open-Label Randomized Controlled Trial","DAWNbreak-120","Inclusion Criteria:\n\n1. According to the National Health Commission(China)'s \"Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2026)\", clinically or pathologically diagnosed as primary liver cancer.\n2. Barcelona Clinic Liver Cancer (BCLC) stage is C.\n3. Planning to receive second-line or third-line anti-tumor therapies.\n4. The dominant syndrome in traditional Chinese medicine diagnosis is damp or heat.\n5. Age: ≥ 18 years and ≤ 75 years.\n\nExclusion Criteria:\n\n1. Expected survival is less than 3 months.\n2. Definitive pathological diagnosis of intrahepatic cholangiocarcinoma or combined hepatocellular-cholangiocarcinoma (cHCC-CCA).\n3. Comorbid severe heart, liver, kidney dysfunction:\n\n   1. heart\n\n      * New York Heart Association(NYHA) cardiac function \\> class II\n   2. liver\n\n      * aspartate aminotransferase \\> 3 times the upper limit of normal\n      * alanine aminotransferase \\> 3 times the upper limit of normal\n      * bilirubin \\> 3 times the upper limit of normal\n   3. kidney\n\n      * creatinine clearance (Cockcroft-Gault) \\\u003C 60 mL\u002Fmin)\n4. Concurrent with other malignant tumors.","75 Years",{"count":210,"type":22},120,[25],"Primary liver cancer is a malignant tumor with a very poor prognosis. Hepatocellular carcinoma(HCC) accounts for approximately 80% of cases. Under the current targeted and immunotherapy-based treatment approaches, the overall survival of patients with advanced HCC has improved significantly compared to targeted therapy alone. However, there are still limitations in therapeutic effectiveness. In addition to the tumor burden, liver reserve function is associated with the prognosis of HCC. Cirrhosis, tumor burden, and anti-tumor treatment can all lead to damage to liver reserve function, which in turn leads to a decrease in patient survival. Currently, there are no specific treatments for deteriorating liver reserve function; only symptomatic treatments such as reducing transaminase levels, bilirubin levels, and blood ammonia levels, as well as diuretics, are available. The indocyanine green(ICG) clearance test allows for precise, dynamic, and quantitative measurement of liver clearance function, making it a commonly used method for assessing liver reserve function in clinical practice.Previous studies have confirmed that its test results are closely related to the prognosis of HCC.\n\nShuganhuazhuo Formula(SHF) is a Chinese herbal medicine used to treat advanced HCC with syndrome of Damp-Heat and Blood stasis. It can inhibit necrosis in the livers of mice in experimental models, reduce fibrosis scores, and demonstrate potential therapeutic effects in protecting the liver, reducing oxidative stress, and preventing fibrosis.\n\nThis study is an open-label randomized controlled trial. Patients with advanced HCC who are receiving second-line or third-line anti-tumor treatment are randomly assigned in a 1:1 ratio to either the control group or the traditional Chinese medicine (TCM) group. The control group receives anti-tumor treatment as recommended by guidelines, while the TCM group receives additional treatment with SHF. SHF involves decocting traditional Chinese medicine ingredients twice daily. Each time, 150 ml of the decoction is prepared and taken orally half an hour after breakfast and dinner. Treatment lasts for 6 months. During this period, the ICG clearance test is performed every 2 months to assess liver reserve function, and quality of life is also evaluated. After the treatment period, follow-ups on survival and safety are conducted every 3 months. This study aims to evaluate the benefits of the SHF in terms of liver reserve function, overall survival, and quality of life in patients with HCC of the syndrome of Damp-Heat and Blood stasis. It also includes exploratory analyses of differences in biomarker expression during treatment.",[214,215,216,217,218],"HCC - Hepatocellular Carcinoma","Chinese Herbal Medicine","ICG (Indocyanine Green)","Overall Survival (All-cause Mortality)","Quality of Life",[220,221,222,223,224,225],"Hepatocellular Carcinoma(HCC)","Chinese herbal medicine","Shuganhuazhuo Formula(SHF)","Liver reserve function","Overall survival","Quality of life","NOT_YET_RECRUITING","2026-07-08",{"date":229,"type":33},"2026-07-09",{"date":231,"type":22},"2026-09-01",{"date":233,"type":22},"2031-08-31",{"name":235,"class":40},"Xiang-Qian",{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":244,"enrollmentInfo":245,"targetDuration":4,"studyType":23,"phases":247,"briefSummary":249,"conditions":250,"keywords":254,"overallStatus":226,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":4},"100641505","phase-2-yang-et-al-anti-pd-1ctla-4-dual-immunotherapy-for-larc-100641505","NCT07596290","Yang et al. Anti-PD-1\u002FCTLA-4 Dual Immunotherapy for LARC","Efficacy and Safety of Neoadjuvant Short-Course\u002FLong-Course Radiotherapy Combined With Anti-PD-1\u002FCTLA-4 Dual Immunotherapy for Locally Advanced Rectal Cancer: A Prospective, Randomized Controlled Trial (RADICAL Trial)","RADICAL","Inclusion Criteria:\n\n1. Age between 18 and 80 years; ECOG performance status 0-1;\n2. Histopathologically confirmed rectal adenocarcinoma via colonoscopy; pMMR or MSS phenotype;\n3. Rectal MRI stage II\u002FIII (excluding T4b); distal tumor margin ≤ 12 cm from the anal verge;\n4. Willingness to comply with study procedures; consent to use tissue and blood samples for medical research purposes;\n5. No prior history of radiotherapy, chemotherapy, or immunotherapy;\n6. No immune system diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, hyperthyroidism\u002Fhypothyroidism, ulcerative colitis, autoimmune hemolytic anemia, HIV infection, etc.);\n7. No severe cardiac, pulmonary, hepatic, or renal dysfunction; no jaundice or gastrointestinal obstruction;\n8. No concurrent acute infection;\n9. Baseline laboratory evaluations completed as required, with results obtained within 14 days before randomization, and laboratory values meeting the following criteria (per CTCAE 5.0):\n\n   * White blood cell count ≥ 2000\u002FμL;\n   * Neutrophil count ≥ 1500\u002FμL;\n   * Platelet count ≥ 100×10³\u002FμL;\n   * Hemoglobin ≥ 9.0 g\u002FdL;\n   * Serum creatinine ≤ 1.5×upper limit of normal (ULN) or creatinine clearance \\> 50 mL\u002Fmin (female: creatinine clearance = \\[140 - age (years)\\] × body weight (kg) × 0.85 \u002F (72 × serum creatinine (mg\u002FdL)); male: creatinine clearance = \\[140 - age (years)\\] × body weight (kg) × 1.00 \u002F (72 × serum creatinine (mg\u002FdL)));\n   * AST ≤ 3×ULN, ALT ≤ 3×ULN, total bilirubin ≤ 1.5×ULN;\n10. No psychiatric\u002Fpsychological disorders affecting social function;\n11. Negative serum pregnancy test (blood HCG) within 1 week before randomization for women of childbearing potential;\n12. Women of childbearing potential must agree to use effective contraception during the study period and for 5 months after the last dose of study drug;\n13. Male subjects who are sexually active with women of childbearing potential must agree to use effective contraception during the study period and for 7 months after the last dose of study drug, and must refrain from sperm donation during this period.\n\nExclusion Criteria:\n\n1. Multiple primary cancers or concurrent other malignant tumors;\n2. Patients requiring emergency surgery due to intestinal obstruction, intestinal perforation, gastrointestinal bleeding, etc.;\n3. Factors affecting oral drug absorption (e.g., inability to swallow, nausea\u002Fvomiting, diarrhea, intestinal obstruction, etc.);\n4. Any uncontrolled, severe concomitant diseases;\n5. Hypersensitivity to any component of the study drugs;\n6. Expected survival \\\u003C 5 years for any reason;\n7. Planned or previous organ\u002Fbone marrow transplantation;\n8. Treatment with immunosuppressants or corticosteroids within 1 month before enrollment;\n9. Central nervous system disorders that may impair ability to provide informed consent or comply with study procedures, as determined by the investigator;\n10. Other conditions that may prevent completion of study treatment (e.g., alcoholism, drug addiction, etc.);\n11. Pregnant or breastfeeding women.","80 Years",{"count":246,"type":22},342,[25,248],"PHASE3","This is a prospective, multicenter, randomized controlled trial aimed at comparing different radiotherapy fractionation regimens combined with sequential dual immunotherapy versus traditional chemoradiotherapy in neoadjuvant treatment for locally advanced rectal cancer (LARC). A total of 342 pMMR\u002FMSS LARC patients will be enrolled and randomly assigned in a 1:1:1 ratio to short-course radiotherapy (5×5Gy) followed by sequential dual immunotherapy (paromlimab + tuvonralimab + CAPEOX), long-course radiotherapy followed by sequential dual immunotherapy, or conventional long-course chemoradiotherapy. The primary endpoint is the complete response rate (pCR + cCR). Secondary endpoints include the proportion of patients adopting the \"watch-and-wait\" strategy, disease-free survival, overall survival, and safety. This study innovatively explores the synergistic mechanism of different radiotherapy fractionations with dual immunotherapy, optimizes the timing of immunotherapy initiation, and constructs a clinical-imaging-pathology multimodal efficacy prediction model, aiming to advance LARC treatment from empirical to precision therapy while achieving organ and function preservation.",[251,252,253],"Locally Advanced Rectal Adenocarcinoma","Neoadjuvant Chemoradiation","Neoadjuvant Immunotherapy",[255,256,257,258,259],"Locally advanced rectal cancer","Neoadjuvant chemoradiation","Anti-PD-1\u002FCTLA-4 Dual Immunotherapy","Short-course radiotherapy","Long-course rediotherapy","2026-06-16",{"date":262,"type":33},"2026-06-17",{"date":264,"type":22},"2026-07-15",{"date":266,"type":22},"2030-12-31",{"name":268,"class":40},"Beijing Friendship Hospital",{"id":270,"slug":271,"hasResults":12,"nctId":272,"briefTitle":273,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":91},"100464463","identification-of-predictive-factors-for-the-response-to-anti-programmed-cell-death-protein-1-pd1-immunotherapy-in-head-and-neck-squamous-cell-carcinoma-100464463","NCT05328024","Identification of Predictive Factors for the Response to Anti-Programmed Cell Death Protein 1 (PD1) Immunotherapy in Head and Neck Squamous Cell Carcinoma","IPRICE","Inclusion Criteria:\n\n* Patients with recurrent squamous-cell carcinoma of the head and neck not amenable to local therapy and\u002For with metastatic disease\n* Tumor directly accessible to clinical examination (tumor of oral cavity and of oropharynx) and\u002For cervical lymphadenopathy accessible to echography allowing to realise biopsy under local anesthesia\n* Indication to treatment by anti-PD1 immunotherapy according to French competent authority recommendations\n* Performance status 0, 1 or 2\n* At least one measurable lesion on RECIST V1.1 criteria\n\nExclusion Criteria:\n\n* Head and neck squamous cell carcinoma accessible to a local treatment\n* Cancer of nasopharynx, sinus or nasal cavity\n* Other histology than epidermoid\n* Patients with contraindication for anti-PD1 immunotherapy",{"count":277,"type":22},60,"This project aims to organise the sampling of blood and tumor at key points of the standard of care of patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (HNSCC). This will allow to identify new potential predictive biomarkers of efficacy of immunotherapy and to investigate the evolution of the tumoral microenvironment after successive systemic treatments.",[280],"Head and Neck Cancer","2026-06-04",{"date":283,"type":33},"2026-06-05",{"date":285,"type":33},"2023-08-25",{"date":287,"type":22},"2029-08-25",{"name":289,"class":40},"Centre Paul Strauss",{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":208,"enrollmentInfo":297,"targetDuration":4,"studyType":23,"phases":298,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":91},"100605437","phase-2-dcrt-vs-surgery-in-resectable-escc-patient-achiving-ccrpr-after-nci-100605437","NCT07162506","DCRT vs. Surgery in Resectable ESCC Patient Achiving cCR\u002FPR After nCI","Definitive Concurrent Chemoradiotherapy Versus Surgery in Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma (ESCC) Who Achieve Complete or Partial Response After Neoadjuvant Chemo-immunotherapy: A Two-arm Phase II Clinical Study (SORT Trial)","Inclusion Criteria:\n\n1. Volunteered to participate, cooperated with follow-up visits.\n2. Aged 18 - 75 years (inclusive), male or female.\n3. Histologically confirmed locally advanced resectable ESCC, clinically staged as Stage II - IVa (cT1N1-3M0, cT2-4aN0-3M0 before treatment; 8th AJCC), and achieve cCR\u002FPR after 2-3 cycles of platinum-based chemotherapy combined with anti-PD-1 or PD-L1 monoclonal antibodies.\n4. Presence of measurable and\u002For non-measurable lesions as defined by Japanese Classification of Esophageal Cancer (12th Edition);\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n6. Estimated survival time ≥ 3 months.\n7. The function of major organs meets the following requirements:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5×10\\^9\u002FL;\n   2. Platelets ≥ 80×10\\^9\u002FL;\n   3. Hemoglobin ≥ 9g\u002FdL;\n   4. Serum albumin ≥ 2.8g\u002FdL;\n   5. Total bilirubin ≤ 1.5 × ULN, ALT, AST and\u002For ALP ≤ 2.5 × ULN;\n   6. Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60mL\u002Fmin;\n   7. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5× ULN (subjects on stable doses of anticoagulation therapy, such as low molecular weight heparin or warfarin, and with INR within the expected therapeutic range of the anticoagulant can be screened);\n8. Comprehensive baseline staging evaluation prior to induction chemo-immunotherapy, including esophagogastroduodenoscopy (with biopsy) and\u002For endoscopic ultrasonography (EUS), contrast-enhanced CT of the neck, chest, and upper abdomen (with or without PET-CT), magnetic resonance imaging (MRI) without MRI contraindications, and upper gastrointestinal contrast.\n9. Patients of childbearing potential must use a medically approved contraceptive method (such as intrauterine device, contraceptive pills, or condoms) during the study treatment period and within 6 months after the end of the study treatment; serum Human Chorionic Gonadotropin (HCG) or urine HCG test must be negative within 72 hours before study enrollment; and must not be breastfeeding.\n\nExclusion Criteria:\n\n1. Surgery for esophageal cancer;\n2. Esophageal fistulae due to infiltration of the primary tumor；\n3. Risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation;\n4. Poor nutritional status, weight loss of ≥10% in the previous 2 months, with no significant improvement after nutritional intervention;\n5. Major surgery or severe trauma within 4 weeks prior to first use of study drug;\n6. Uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;\n7. Received or receiving any of the following treatments in the past:\n\n   1. Radiotherapy or targeted therapy;\n   2. Participation in a study of an investigational agent or device within 4 weeks before the first dose of study treatment;\n   3. Systemic treatment with corticosteroids (\\>10 mg prednisone equivalent dose per day) or other immunosuppressive agents is required for 2 weeks before the first dose of study treatment (except for the use of corticosteroids for local inflammation of the esophagus and for the prevention of allergy and nausea and vomiting). Other special circumstances need to be communicated to the sponsor. Inhaled or topical steroids and adrenocorticotropic hormone replacement at doses \\>10mg\u002Fday prednisone efficacy dose are permitted if the patient does not have active autoimmune disease;\n   4. Received an anti-tumour vaccine or received a live vaccine within 4 weeks before the first dose of study treatment;\n8. Any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); Except for patients with vitiligo or those who had asthma or allergies in childhood but did not need any intervention as adults; patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone and type I diabetes mellitus treated with stable doses of insulin may be included;\n9. Diagnosis of immunodeficiency, including positive HIV test, other acquired\u002Fcongenital immunodeficiency diseases, organ transplantation and allogeneic bone marrow transplantation;\n10. Diagnosis of uncontrolled cardiac clinical symptoms or disease such as: a. NYHA II or above heart failure; b. unstable angina; c. myocardial infarction within 1 year; d. clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;\n11. Severe infections (CTCAE \\> grade 2), such as severe pneumonia requiring hospitalisation, bacteraemia, infectious co-morbidities, etc., within 4 weeks before the first use of study treatment; Baseline chest imaging suggestive of active lung inflammation, signs and symptoms of infection requiring oral or intravenous antibiotic treatment within 2 weeks before the first use of study treatment, except for prophylactic antibiotic use;\n12. History of interstitial lung disease or non-infectious pneumonia, or pulmonary insufficiency ≥ grade 3 as confirmed by pulmonary function tests;\n13. Active tuberculosis infection detected by history or CT examination, or history of active tuberculosis infection within 1 year before enrollment or more than 1 year previously without regular treatment;\n14. Presence of active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 104 copies\u002FmL), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection);\n15. Presence of abnormal sodium, potassium, and calcium laboratory test values greater than grade 1 within 2 weeks prior to enrollment that do not improve with treatment;\n16. Known hypersensitivity to large protein preparations, or to any of the components of camrelizumab, or anaphylaxis, hypersensitivity, or contraindication to paclitaxel or carboplatin or to any of the components used within their preparations;\n17. Previously diagnosed with any other malignancy within 5 years before the first use of the investigational drug, except for malignancies with low risk of metastasis and death (5-year survival rate\\>90%), such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ.\n18. As judged by the investigator, the subject has other factors that may lead to forced termination of the study midway.",{"count":210,"type":22},[25],"This is a multi-center, Phase II clinical study aiming to evaluate the efficacy, safety, and organ preservation feasibility of definitive concurrent chemoradiotherapy versus surgery in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC) who achieve clinical complete response\u002Fpartial response (cCR\u002FPR) after neoadjuvant chemo-immunotherapy.\n\nA total of 120 eligible subjects will be enrolled. Patients with cCR\u002FPR after 2-3 cycles of neoadjuvant chemo-immunotherapy will be grouped based on personal willing: the control group (n=60) will receive radical esophagectomy + mediastinal lymph node dissection; the experimental group (n=60) will receive definitive concurrent chemoradiotherapy (radiotherapy: 50.4 Gy\u002F28f; chemotherapy: nab-paclitaxel 175mg\u002Fm² + carboplatin AUC=5, q21d for 2 cycles). All the patients will receive camrelizumab maintenance therapy (200mg q21d) up to 1 year.",[301],"Esophageal Cancer","2026-05-26",{"date":304,"type":33},"2026-05-29",{"date":306,"type":33},"2025-11-03",{"date":308,"type":22},"2030-08-30",{"name":310,"class":40},"Tianjin Medical University Cancer Institute and Hospital",{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":208,"enrollmentInfo":318,"targetDuration":4,"studyType":23,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":226,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":4},"100638624","phase-2-tace-combined-with-thermal-ablation-and-adc-pd-1-and-chemotherapy-as-first-line-treatment-for-her2-highly-expressing-gastric-cancer-with-liver-metastases-a-multicenter-single-arm-prospective-clinical-study-100638624","NCT07602140","TACE Combined With Thermal Ablation and ADC, PD-1, and Chemotherapy as First-line Treatment for HER2-highly-expressing Gastric Cancer With Liver Metastases: A Multicenter, Single-arm Prospective Clinical Study.","TACE Combined With Thermal Ablation and Antibody-drug Conjugates, Immune Checkpoint Inhibitors, and Chemotherapy as First-line Treatment for HER2-highly-expressing Gastric Cancer With Liver Metastases: a Multicenter, Single-arm Prospective Clinical Study.","Inclusion Criteria:\n\n1. Participants voluntarily joined this study, signed informed consent forms, demonstrated good compliance, and cooperated with follow-up.\n2. Male or female, aged 18 or older and 75 or younger;\n3. ECOG score is 0-1;\n4. Expected survival time ≥ 3 months;\n5. Imaging examinations suggest gastric cancer with liver metastasis;\n6. Histopathologically confirmed gastric adenocarcinoma and liver metastatic adenocarcinoma;\n7. Enhanced CT scans were used to observe the staining of liver metastases; tumors with good blood supply were included in this study.\n8. Immunohistochemical results of gastric adenocarcinoma and\u002For liver metastatic adenocarcinoma confirmed high expression of HER2 (defined as: IHC 2+ or 3+);\n9. No prior history of antibody-drug conjugate ( ADC ) therapy ; Note: Patients who have relapsed more than 6 months after receiving neoadjuvant (radiotherapy) chemotherapy + radical surgery, or who have relapsed more than 6 months after completing adjuvant (radiotherapy) chemotherapy or radical concurrent chemoradiotherapy;\n10. Within 28 days prior to the first administration of the study drug, the target lesion had not received local treatment (including transarterial chemoembolization\u002FTACE, hepatic artery infusion chemotherapy\u002FTAC, radiotherapy, radiation embolization or ablation, etc.);\n11. There must be at least one liver metastasis meeting the following criteria:\n\nAt least one patient is eligible for TACE and\u002For thermal ablation treatment; 12. In addition to the ablated lesion, there is at least one measurable lesion in the liver or outside the liver (according to RECIST 1.1 criteria, the long axis of the tumor lesion on CT scan is ≥10 mm, and the short axis of the lymph node lesion on CT scan is ≥10 mm) (for assessing the remote effect).\n\n1.3 . Damage caused by other treatments received by the subject has recovered, including those received other cytotoxic drugs, radiotherapy or surgery for ≥4 weeks, and the wounds have completely healed ; 1.4 . Subjects should not have previously received anti-PD-1, PD-L1, CTLA-4, or CAR-T immunotherapy ; 1.5 . Asymptomatic brain metastases or control of brain metastases after radiotherapy ; 1.6 . Major organ functions are normal, and subjects must meet the following laboratory indicators:\n\n1)In the absence of granulocyte colony-stimulating factor use in the past 14 days, the absolute neutrophil count (ANC) is ≥1.5 x 10⁹ \u002FL .\n\n2)10⁹ \u002FL without blood transfusion in the past 14 days ; 3)Hemoglobin \\>9 g\u002FdL in the absence of blood transfusion or erythropoietin use within the past 14 days ; 4)There is no active bleeding, such as hematemesis, melena, gingival bleeding, epistaxis, or hemorrhoidal bleeding, and the fecal occult blood test is ≤ +.\n\n5)Total bilirubin ≤1.5 × upper limit of normal (ULN); 6)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5.0×ULN , alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, and total serum bilirubin (TBIL) ≤1.5×ULN.\n\n7)Serum creatinine ≤1.5×ULN or creatinine clearance ( CrCl ) ≥50 mL\u002Fmin calculated according to the Cockcroft-Gault formula; For women: CrCl = (140 - age × weight (kg) × 0.85 \u002F 72 × serum creatinine (mg\u002FdL)) For males: CrCl = (140 - age × weight (kg) × 1.00 \u002F 72 × serum creatinine (mg\u002FdL)) 8)Good coagulation function is defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times the ULN; and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; (For patients receiving anticoagulation therapy, such as those taking anticoagulants like aspirin , warfarin, or clopidogrel , the medication should generally be discontinued for at least 5-7 days, and the investigator should determine that both INR and APTT are within a safe and effective therapeutic range).\n\n9)Normal thyroid function is defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH exceeds the normal range, subjects with normal total T3 (or FT3) and FT4 may also be enrolled.\n\n10)Cardiac enzyme levels within the normal range (simply laboratory abnormalities that are not clinically significant, as determined by the researchers, are also allowed to be enrolled); 11)Doppler ultrasound assessment showed a left ventricular ejection fraction (LVEF) ≥ 50%.\n\n1.7 . Patients with potential fertility need to use a medically approved contraceptive method (such as an intrauterine device, birth control pill, or condom) during the study treatment period and for one month after the end of the study treatment period; and must have a negative serum or urine HCG test within 72 hours before study enrollment, and must not be breastfeeding.\n\nExclusion Criteria:\n\nSubjects meeting the following criteria were not eligible for inclusion in this study:\n\n1. diagnosed with other malignant tumors within 5 years prior to the first dose and who are not cured (excluding radically resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ that has been radically removed);\n2. Currently participating in interventional clinical research treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first dose;\n3. Previous treatment with the following: antibody-drug conjugates, anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or co-inhibit T cell receptors (e.g. CTLA-4, OX-40, CD137);\n4. Within 28 days prior to the first administration of the study drug, the target lesion had received local treatment (including transarterial chemoembolization\u002FTACE, hepatic artery infusion chemotherapy\u002FTAC, radiotherapy, radioembolization or ablation, etc.);\n5. The patient had received systemic treatment with traditional Chinese medicine or immunomodulatory drugs with antitumor indications within 2 weeks prior to the first dose ;\n6. Subjects with any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or whose childhood asthma was completely remitted and requires no intervention in adulthood are eligible to be included; subjects with asthma requiring medical intervention with bronchodilators are not eligible to be included).\n7. Subjects are currently using immunosuppressants, or systemic or absorbable topical corticosteroids, to achieve immunosuppression (dose \\>10 mg\u002F day prednisone or other equivalent corticosteroids), and have continued to use them within 2 weeks prior to enrollment; Note: Physiological doses of glucocorticoids (≤10 mg\u002Fday prednisone or equivalent drugs) are permitted.\n8. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n9. known hypersensitivity to the study drugs vedicetumab , sintilimab, and tegafur ;\n10. Active gastrointestinal bleeding or high risk of bleeding within 2 weeks prior to screening; or gastrointestinal perforation\u002Ffistula within 6 months prior to screening; intestinal obstruction, within 30 days after major surgery, uncontrolled hypertension, NYHA class III-IV heart failure, or severe hepatic or renal failure (class 4).\n11. Prior to starting treatment, the individual has not fully recovered from any toxicity and\u002For complications caused by any intervention (i.e., ≤ grade 1 or at baseline, excluding fatigue or hair loss).\n12. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1\u002F2 antibody positive );\n13. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number greater than the upper limit of normal value in the laboratory of the research center);\n\nNote : Hepatitis B subjects who meet the following criteria may also be enrolled :\n\n1. before the first dose , the subject should receive anti-HBV therapy throughout the study chemotherapy treatment to avoid viral reactivation.\n2. Subjects with positive, negative, anti-HBs, or negative HBV viral loads do not require prophylactic anti-HBV treatment, but close monitoring for viral reactivation is necessary.\n\n14.Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the detection limit); 15.Those who have received a live vaccine within 4 weeks prior to screening or plan to receive any vaccine during the study period (Note: Injectable inactivated virus vaccines against seasonal influenza are permitted within 30 days prior to the first dose; however, intranasal live attenuated influenza vaccines are not permitted).\n\n16.Pregnant or breastfeeding women; 17.The presence of any serious or uncontrollable systemic disease, such as:\n\n1. Significant and uncontrollable abnormalities in rhythm, conduction, or morphology on resting electrocardiogram, such as complete left bundle branch block, second-degree or higher cardiac conduction block, ventricular arrhythmia, or atrial fibrillation.\n2. According to NYHA standards, heart failure is classified as grade III or IV, or echocardiography shows a left ventricular ejection fraction (LVEF) \\\u003C50%; unstable angina, congestive heart failure, or NYHA grade 3 or higher heart failure.\n3. Subjects who had experienced acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction or acute coronary syndrome within one month, and whose cardiovascular clinical symptoms or diseases were not well controlled;\n4. A history of non-infectious pneumonia requiring glucocorticoid therapy within one year prior to the first dose, or current clinically active interstitial lung disease;\n5. Active pulmonary tuberculosis;\n6. prior to the first use of the study drug , such as severe pneumonia, bacteremia, or infectious complications requiring hospitalization; baseline chest imaging showed active lung inflammation; symptoms and signs of infection existed within 2 weeks prior to the first use of the study drug; or oral and intravenous antibiotics were required, excluding prophylactic antibiotic use.\n7. The patient presents with clinically active diverticulitis, abdominal abscess, and gastrointestinal obstruction.\n8. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n9. Patients with a clear tendency to gastrointestinal bleeding include those with the following conditions: active local ulcer lesions and fecal occult blood (++) {those with ++ are not eligible}; those with a history of melena or hematemesis within the past 2 months;\n10. Those with abnormal coagulation function (INR\\>1.5 APTT\\>1.5 ULN) and bleeding tendency;\n11. Long-term unhealed wounds or fractures; major surgery or severe traumatic injury, fracture or ulcer within 4 weeks;\n12. Poorly controlled diabetes (fasting blood glucose (FBG) \\> 10 mmol\u002FL);\n13. Urinalysis results indicate urine protein ≥++, and 24-hour urine protein quantification is confirmed to be \\>1.0 g;\n14. Patients with mental disorders who are unable to cooperate with treatment;\n15. Patients requiring treatment and with a history of lung disease that could potentially affect surgery include, but are not limited to, interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, and acute lung disease.\n16. The patient presents with clinically active diverticulitis, abdominal abscess, and gastrointestinal obstruction.\n17. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n18. Patients with mental disorders who are unable to cooperate with treatment;\n19. The presence of systemic diseases that researchers have determined are not stably controlled, including diabetes and hypertension; 18.Candidates must have a history of active autoimmune disease requiring systemic treatment (such as immunomodulatory drugs, corticosteroids, or immunosuppressants) within the past two years prior to screening, with permitted replacement therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for renal or pituitary insufficiency), or a history of refractory autoimmune disease. Candidates must have used systemic steroids (dose \\> 10 mg\u002Fday prednisone or equivalent dose of other glucocorticoids) or other systemic immunosuppressive therapies within 14 days prior to screening.\n\n19.Patients must have had other malignant tumors within the 5 years prior to screening, except for those that have been cured by treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with radical surgery).\n\n20.Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 21.Prior to starting treatment, the individual has not fully recovered from any toxicity and\u002For complications caused by any intervention (i.e., ≤ grade 1 or at baseline, excluding fatigue or hair loss).\n\n22.Medical history or disease evidence that may interfere with trial results, prevent participants from participating in the study throughout the process, abnormal treatment or laboratory test values, or other circumstances that the investigator deems unsuitable for enrollment.",{"count":319,"type":22},40,[25],"This study is a multicenter, single-arm prospective clinical trial designed to evaluate the efficacy of TACE combined with thermal ablation, antibody-drug conjugates, immune checkpoint inhibitors, and first-line chemotherapy for the treatment of HER2 - highly expressing gastric cancer with liver metastases.",[323],"Gastric Cancer With Liver Metastases","2026-05-17",{"date":326,"type":33},"2026-05-22",{"date":328,"type":22},"2026-08-01",{"date":330,"type":22},"2029-08-01",{"name":332,"class":333},"Shandong Provincial Hospital","OTHER_GOV",{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":208,"enrollmentInfo":341,"targetDuration":4,"studyType":23,"phases":343,"briefSummary":344,"conditions":345,"keywords":347,"overallStatus":226,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":91},"100612789","phase-2-safety-and-efficacy-of-radiotherapy-combined-with-immunochemotherapy-in-pre-treated-sclc-patients-with-liver-metastases-100612789","NCT07258147","Safety and Efficacy of Radiotherapy Combined With Immunochemotherapy in Pre-treated SCLC Patients With Liver Metastases","Clinical Study on the Efficacy and Safety of Radiotherapy Combined With Immunotherapy and Chemotherapy for Pre-treated Patients With Small Cell Lung Cancer and Liver Metastases","Inclusion Criteria:\n\n1. Aged 18 to 75 years, with an ECOG Performance Status of 0-2.\n2. Histologically confirmed stage IV non-small cell lung cancer (NSCLC) or extensive-stage small cell lung cancer, with radiologically confirmed liver metastases (at least one measurable lesion with the longest diameter ≥ 1 cm).\n3. Prior failure (due to progression or intolerance) to platinum-based doublet chemotherapy and PD-1\u002FPD-L1 inhibitor therapy.\n4. Adequate liver function reserve (Child-Pugh class A or B, ALT\u002FAST ≤ 5 × ULN, total bilirubin ≤ 1.5 × ULN).\n5. Life expectancy of at least 3 months.\n6. Normal function of major organs and no severe dysfunction of the hematopoietic, cardiac, pulmonary, hepatic, renal, or bone marrow systems, or immunodeficiency diseases.\n7. Within one week prior to enrollment, bone marrow and organ function meet the following criteria:Hemoglobin ≥ 80 g\u002FL, neutrophil count ≥ 1.5 × 10⁹\u002FL, and platelet count ≥ 70 × 10⁹\u002FL. Renal function: Serum creatinine ≤ 1.5 × ULN, and endogenous creatinine clearance rate ≥ 55 ml\u002Fmin.Liver function: Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN (if liver metastases are present, total bilirubin ≤ 3 × ULN and transaminases ≤ 5 × ULN are acceptable).\n8. Voluntarily participates and provides written informed consent.\n9. Good compliance and willingness to adhere to the study visit schedule and other protocol requirements.\n10. Willingness to provide blood and tissue samples for biomarker testing.\n11. Judged by the radiation oncologist to have no contraindications to liver radiotherapy. Patients who agree to receive immunotherapy, chemotherapy, and radiotherapy.\n12. For patients of childbearing potential: agreement to use effective contraception during the study period and for at least 6 months after the last study treatment; negative serum or urine pregnancy test within 7 days prior to study entry; and not breastfeeding. Male patients with partners of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Presence of any active autoimmune disease or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism \\[may be included if controlled with hormone replacement therapy\\]); prior liver radiotherapy or liver transplantation; history of liver cirrhosis (Fibroscan ≥ F3), portal hypertension, or hepatic encephalopathy.\n2. Congenital or acquired immunodeficiency, such as Human Immunodeficiency Virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU\u002Fml), hepatitis C (positive HCV antibody and HCV RNA above the lower limit of detection of the assay), or co-infection with both hepatitis B and C.\n3. Uncontrolled or significant cardiac disease, including: (a) NYHA Class II or higher heart failure; (b) Unstable angina; (c) Myocardial infarction within the past 1 year; (d) Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.\n4. Severe infection or serious comorbidities within 4 weeks prior to the first dose of study treatment.\n5. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n6. History of other primary malignancies within the past 5 years.\n7. Known allergy to any of the trial drugs or their excipients.\n8. Pregnant or lactating women, or subjects of childbearing potential unwilling to use effective contraception during the study period.\n9. Patients with Child-Pugh class B or C liver insufficiency.\n10. Any other contraindication as determined by the investigator to preclude participation in the study.",{"count":342,"type":22},30,[25],"This is clinical trial evaluating the safety and efficacy of radiotherapy combined with immunotherapy and chemotherapy in patients with extensive-stage small-cell lung cancer (ES-SCLC) and liver metastases.",[346],"Lung Cancer (SCLC)",[348,349,350,351],"SCLC","Radiotherapy","Immunotherapy","Chemotherapy","2026-05-04",{"date":354,"type":33},"2026-05-05",{"date":356,"type":22},"2026-10-31",{"date":358,"type":22},"2028-12-30",{"name":360,"class":40},"Sichuan University",{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":368,"enrollmentInfo":369,"targetDuration":4,"studyType":23,"phases":371,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":91},"100597712","phase-2-bits-to-hcc-study-haiciparomlimabtuvonralimab--bevacizumab--sbrt-for-bclc-c-hcc-with-pvtt-andor-oligometastases-100597712","NCT07062055","BITS-TO-HCC Study: HAIC+Iparomlimab\u002FTuvonralimab + Bevacizumab + SBRT for BCLC-C HCC With PVTT and\u002For Oligometastases","Bevacizumab Plus Iparomlimab\u002FTuvonralimab With Hepatic Artery Infusion Chemotherapy Followed by Stereotactic Body Radiotherapy in Patients With BCLC Stage C Hepatocellular Carcinoma With Thrombus and\u002For Extrahepatic Oligometastases (BITS-TO-HCC): Study Protocol of a Prospective, Single- Center, Single-Arm, Phase II Study","Inclusion Criteria:\n\n1. Male or female patients aged between 18 and 70 years.\n2. Unresectable HCC, BCLC Stage C according to the BCLC strategy-2025 update, with staging established via biopsy pathology and\u002For clinical diagnosis.\n3. Child-Pugh class A without clinically significant hepatic decompensation; Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n4. Metastatic burden and SBRT eligibility\n\n   * Extrahepatic oligometastatic disease defined as ≤3 involved organs with ≤5 total metastatic lesions\n   * All intended intrahepatic and\u002For extrahepatic SBRT targets must satisfy protocol-specified target-coverage, liver reserve, and organ-at-risk (OAR) constraints within a composite 5-fraction plan\n5. Prognosis \\& measurable disease\n\n   * Life expectancy ≥3 months\n   * ≥1 measurable lesion (per RECIST 1.1):\n   * Tumor: ≥10 mm (CT long axis)\n   * Lymph node: ≥15 mm (CT short axis)\n6. Prior therapy\n\n   * Prior locoregional therapy permitted：radiofrequency ablation (RFA), TACE, or HAIC, provided that:\n   * Documented radiographic progression or intolerance after the prior therapy\n   * Washout ≥28 days\n   * Treatment-related toxicities recovered to ≤Grade 1 (alopecia and peripheral neuropathy ≤Grade 2 allowed)\n7. Laboratory and virologic requirements\n\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤5 × upper limit of normal (ULN); total bilirubin ≤3 × ULN; serum albumin ≥28 g\u002FL\n   * Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL\u002Fmin\n   * Urine dipstick protein \\\u003C2+; if baseline dipstick proteinuria is ≥2+, 24-hour urinary protein must be \\\u003C1 g\n   * International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN\n\nExclusion Criteria:\n\n1. Histopathological exclusions\n\n   * Mixed HCC subtypes: Fibrolamellar HCC or sarcomatoid HCC or cholangiocarcinoma components\n2. Curative local therapy candidacy\n\n   * Current candidacy for resection, liver transplant, or RFA\n3. RT infeasibility\n\n   * Prior radioembolization\n   * Single liver tumor ≥15 cm or total intrahepatic tumor diameter ≥20 cm\n   * more than 5 discrete intrahepatic parenchymal foci are present\n   * direct tumor extension into the stomach, duodenum, small bowel, or large bowel\n   * measurable common or main-branch biliary duct involvement\n   * Prior liver radiotherapy that would result in excessive overlap with the planned treatment fields\n4. Prior systemic therapies\n\n   * Received targeted-immunotherapy for HCC (e.g., PD-(L)1 inhibitors + tyrosine kinase inhibitors (TKIs))\n   * Prior immunotherapy: anti-PD-(L)1\u002FCTLA-4 or chimeric antigen receptor T-cell therapy\n5. Hemorrhage\u002Fportal hypertension and hepatic decompensation risk\n\n   * Variceal bleeding within 6 months.\n   * Untreated or high-risk esophagogastric varices (e.g., grade ≥2 on endoscopy within 3 months) or other clinical evidence of portal hypertension with high bleeding risk per investigator.\n   * Moderate or severe ascites\n   * History of or active hepatic encephalopathy\n   * History of hemoptysis (≥2.5 mL of bright red blood per episode) within 28 days before study treatment\n   * Evidence of bleeding diathesis or significant coagulopathy\n   * Current or recent (within 10 days before study treatment) use of aspirin (≥325 mg\u002Fday), dipyridamole, ticlopidine, clopidogrel, cilostazol, or therapeutic-dose oral\u002Fparenteral anticoagulants or thrombolytic agents\n6. Allergy to any component of iparomlimab\u002Ftuvonralimab or bevacizumab\n7. Comorbidities\n\n   * Active autoimmune disease or a history of autoimmune or inflammatory disease that may relapse; exceptions include hypothyroidism controlled with hormone replacement only, controlled celiac disease, and skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia)\n   * Any condition requiring systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive medication within 14 days before study treatment\n   * Active or uncontrolled infection, including tuberculosis, or known HIV infection\n   * Prior allogeneic stem cell transplantation or organ transplantation\n   * Inadequately controlled hypertension, defined as systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure \\>90 mmHg despite optimal medical management, or a history of hypertensive crisis or hypertensive encephalopathy\n   * History within 6 months before study treatment of myocardial infarction, unstable angina, symptomatic heart failure (New York Heart Association class ≥II), cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other serious thromboembolic events\n   * Major surgical procedure within 28 days before study treatment, or serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture\n   * History within 6 months before study treatment of gastrointestinal perforation, abdominal or tracheoesophageal fistula, or intra-abdominal abscess","70 Years",{"count":370,"type":22},54,[25],"This single-center, prospective, single-arm Phase II clinical trial is designed to evaluate the efficacy and safety of combining hepatic artery infusion chemotherapy (HAIC, for up to 4 cycles) with iparomlimab\u002Ftuvonralimab plus bevacizumab followed by stereotactic body radiotherapy (SBRT) in patients with Barcelona Clinic Liver Cancer (BCLC) stage C hepatocellular carcinoma (HCC) who present with portal vein tumor thrombus (PVTT) or extrahepatic oligometastatic disease. The study aims to determine whether this combination strategy can prolong progression-free survival (PFS), while also improving overall survival (OS), objective response rate (ORR), disease control rate (DCR), and local control rate (LCR), as well as maintaining quality of life (QoL). In addition, the trial will systematically evaluate the safety profile and treatment-related toxicities associated with this regimen.",[374,375,376,349,350,377],"Hepatocellular Carcinoma","Portal Vein Tumor Thrombus","Oligometastases","Hepatic Artery Infusion Chemotherapy",{"date":379,"type":33},"2026-05-08",{"date":381,"type":33},"2025-07-25",{"date":383,"type":22},"2029-07-25",{"name":385,"class":40},"Shandong Cancer Hospital and Institute",{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":23,"phases":396,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":141},"100592962","phase-2-timing-of-minimally-invasive-local-treatment-after-first-line-systemic-therapy-in-oligometastatic-esophageal-or-gastric-adenocarcinoma-100592962","NCT07000253","Timing of Minimally Invasive Local Treatment After First-Line Systemic Therapy in Oligometastatic Esophageal or Gastric Adenocarcinoma","Timing of Minimally Invasive Local Treatment After First-Line Systemic Therapy in Oligometastatic Esophageal or Gastric Adenocarcinoma: A Randomized Prospective Clinical Study (OMEC-5)","OMEC-5","Inclusion Criteria:\n\n* Age ≥18 years\n* Ability to provide written informed consent\n* Histologically confirmed esophageal, gastric or gastroesophageal junction tumor with oligometastatic (M1) disease defined according to the OMEC consensus statement:\n\n  * One organ with ≤3 metastases or 1 involved extra-regional lymph node station (based on the TNM 8 classification)\n  * ≤3 unilobar liver metastases or ≤2 bilobar liver metastases\n  * ≤ 3 unilateral lung metastases\n  * Unilateral adrenal gland involvement\n  * Metastasis confined to 1 bone structure or 1 soft tissue compartment\n* Synchronous oligometastatic disease with a resectable primary tumor or metachronous oligometastatic disease (in the event of a locoregional recurrence this should be resectable)\n* Metastases should be deemed amenable by the international multidisciplinary expert team for radical local treatment\n* WHO performance status 0-2\n* Indication for checkpoint inhibition and\u002For targeted therapy\n\n  * PD-L1 with a CPS of 1 or higher as per local clinical practice for immunotherapy use\n  * HER2 overexpression as per local clinical practice for trastuzumab use\n  * Claudin 18.2 overexpression as per local clinical practice for zolbetuximab use.\n  * Any other biomarker that allows targeted therapy in first line approved by EMA\n* No prior systemic therapy for metastatic disease\n* CT-scan ≤8 weeks prior to inclusion\n* Ability to undergo local treatment and start systemic treatment beyond 18 weeks of total systemic treatment.\n\nExclusion Criteria:\n\n* Squamous cell carcinoma\n* Brain metastases\n* Peritoneal or pleural carcinomatosis\n* Patients with MSI dMMR\n* Uncontrolled immunodeficiency (e.g. AIDS)\n* Peripheral neuropathy \\>CTCAE grade 1, precluding start of full dose oxaliplatin treatment\n* Both organ metastasis and extra-regional lymph node metastasis\n* Conditions precluding local treatment or systemic therapy for oligometastatic disease:\n\n  * Serious medical comorbidities precluding local treatment (e.g., interstitial lung disease in patients with pulmonary metastasis)\n  * Clinical or radiological evidence of spinal cord compression or epidural tumor within 2 mm of the spinal cord\n  * Simultaneous other malignancy or previous other malignancy with a disease-free period of \\\u003C5 years, except adequately treated non-melanoma skin cancer or in-situ cancers\n  * Uncontrolled (bacterial) infections\n  * Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments\n  * Uncontrolled angina pectoris, cardiac failure or clinically significant arrhythmias\n  * Continuous use of immunosuppressive agents equivalent to \\>10 mg daily prednisone\n  * Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine\n  * Pregnancy or breast feeding\n  * Patients (M\u002FF) with reproductive potential not implementing adequate contraceptive measures",{"count":395,"type":22},290,[25,248],"Purpose of the Study:\n\nThis clinical study investigates whether a shorter or longer duration of systemic therapy before local treatment (surgery or radiation) results in better disease control in patients with esophageal or gastric cancer with a limited number of metastases, also known as oligometastases.\n\nBackground:\n\nIn about 25% of patients with advanced esophageal or gastric cancer, the disease spreads to only a few sites (oligometastatic disease). Prior studies suggest that local treatment after systemic therapy may extend survival in this subgroup. However, it is unclear how long systemic therapy should last before initiating local treatment. The OMEC-5 study aims to clarify this and identify potential biomarkers for treatment response.\n\nStudy Design:\n\nInitiated by Amsterdam UMC and UMCU and conducted in multiple hospitals across Europe.\n\nTotal of 414 patients to be enrolled.\n\nDuration: \\~53 months (35 months enrollment + 18 months follow-up).\n\nApproved by the medical ethics committee at Amsterdam UMC.\n\nProcedure:\n\nEligibility screening: Includes physical exam, blood tests (incl. circulating tumor cells), medical history review, and confirmation of oligometastases by an expert panel.\n\nInitial treatment: All participants receive 4 months of standard systemic therapy (chemotherapy + immunotherapy and\u002For targeted therapy depending on tumor markers like HER2 or Claudin 18.2).\n\nResponse assessment (Review 1): Imaging and\u002For laparoscopic examination.\n\nIf oligometastases persist and tumors have not progressed, participants are randomized into two groups:\n\nGroup A (longer systemic therapy): 4 more months of systemic therapy, then local treatment if disease is stable, followed by 4 months of immunotherapy ± targeted therapy.\n\nGroup B (shorter systemic therapy): Immediate local treatment followed by 4 months of systemic therapy, then reassessment and potentially 4 months of immunotherapy ± targeted therapy.\n\nFollow-up: Regular scans and quality-of-life questionnaires (5 times), and periodic blood sampling (4 times).\n\nTreatments Involved:\n\nChemotherapy: CapOx or FOLFOX\n\nImmunotherapy: nivolumab or pembrolizumab\n\nTargeted therapy: trastuzumab (HER2-positive) or zolbetuximab (Claudin 18.2-positive)\n\nPotential Benefits and Risks:\n\nPatients may benefit from better disease control and a personalized treatment strategy.\n\nKnown side effects relate to the standard treatments used (chemo, immuno, targeted therapies), and no extra medical risk is expected beyond routine care.\n\nPossible inconveniences include blood draws, scans, minor surgery (laparoscopy), and time investment.\n\nData and Sample Handling:\n\nPersonal data and tumor\u002Fblood samples are coded and securely stored.\n\nData may be used for future cancer research if the patient consents.\n\nParticipants can withdraw at any time.\n\nConfidentiality and Privacy:\n\nPatient data are kept confidential, and participants have rights to access or delete their data. Privacy measures comply with GDPR and Dutch law.\n\nCompensation and Insurance:\n\nParticipation is voluntary, with no financial compensation. Standard treatment costs are covered by healthcare insurance. No extra insurance is required, as the treatment aligns with standard care practices.",[301,399,400,401,402,403],"Gastric (Stomach) Cancer","Gastric Adenocarcinoma","Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma","Esophageal Carcinoma","Gastric (Cardia, Body) Cancer","2026-05-03",{"date":406,"type":33},"2026-05-07",{"date":408,"type":33},"2026-04-29",{"date":410,"type":22},"2034-01",{"name":412,"class":40},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":91},"100353008","gastroparesis-outcome-longitudinal-database-enrolled-numerically-100353008","NCT03876288","Gastroparesis Outcome Longitudinal Database Enrolled Numerically","GOLDEN","Inclusion:\n\n* Patients with the symptoms (Sx) of drug refractory gastroparesis\n* Disordered nutrition by standardized assessment\n* Ability to assess current symptom status\n* Ability to measure other medical conditions\n\nExclusion:\n\n* Anatomic obstruction of the GI Tract\n* Pregnancy\n* Inability of patient or guardian to sign informed consent, if needed\n* Psychiatric disorders precluding assessment and treatment of the patient's GI condition",{"count":421,"type":22},3000,"GOLDEN is a longitudinal database of patients with the symptoms (Sx) of gastroparesis (Gp) who were seen and recorded at the University of Louisville from 2012 and is ongoing. Patients are enrolled and followed by sequential numbers and may include legacy patients seen at other centers by some of the same team and who are reported as part of the series. Outcome relate to patients Sx, survival, quality of life and other measures as detailed below, over time. The study tracks patients regardless of treatment but specifically focuses on GI Neuromodulation (gastric electrical stimulation - GES), Immunotherapy (IVIG), and Pyloric therapies (pyloroplasty, endoscopic). If treatments were administered GOLDEN allows for examination and stratification of outcome by groups both at baseline and at follow up.",[424],"Gastroparesis","2026-04-17",{"date":427,"type":33},"2026-04-20",{"date":429,"type":33},"2013-01-01",{"date":431,"type":22},"2028-01-01",{"name":433,"class":40},"University of Louisville",{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":208,"enrollmentInfo":441,"targetDuration":4,"studyType":23,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":226,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":4},"100633109","phase-1-sequential-folfox-haic-tace-plus-sintilimab-bevacizumab-neoadjuvant-therapy-versus-direct-resection-in-resectable-high-risk-recurrence-hepatocellular-carcinoma-100633109","NCT07522411","Sequential FOLFOX-HAIC-TACE Plus Sintilimab-Bevacizumab Neoadjuvant Therapy Versus Direct Resection in Resectable High-Risk Recurrence Hepatocellular Carcinoma","Efficacy and Safety of Sequential FOLFOX-HAIC Followed by TACE Combined With Sintilimab Plus Bevacizumab as Neoadjuvant Therapy, Followed by Surgical Resection, Versus Direct Surgical Resection in Patients With Resectable Hepatocellular Carcinoma and High-Risk Recurrence Factors: A Single-Center, Open-Label, Two-Arm, Randomized Study","Inclusion Criteria:\n\n1.Fully understanding and voluntarily signing the informed consent form, complying with the requirements and evaluation schedule of this study; 2.18 to 75 years old; 3.Hepatocellular carcinoma diagnosed by histopathology; 4.Imaging examination results meeting the definition of high-risk recurrence risk factors in this study: 2-4 multiple tumors; the size of the dominant tumor was \\>=5 cm; CNLC-Ⅲa incorporated with portal vein tumor thrombus \\[Vp1\u002F2\u002F3\\]; 5.Surgical evalution with a radically resectable tumor; 6.Child-Pugh class A; 7.ECOG PS： 0\\~1; 8.hepatocellular carcinoma who had never received previous form of systemic therapy; 9.At least one measurable lesion that can be accurately assessed by computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for assessment per mRECIST 1.1; 10.The main organ functions are normal, including the following criteria: (1) sufficient bone marrow function, defined as neutrophils ≥ 1.5 × 10 \\^ 9\u002FL, hemoglobin (Hb) ≥ 90 g\u002FdL, platelets ≥ 50 × 10 \\^ 9\u002FL; (2) good liver function, defined as serum total bilirubin ≤ 1.5 × ULN, aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN, albumin ≥ 28 g\u002FL; (3) good coagulation function, defined as international normalized ratio (INR) ≤ 2.3 or prothrombin time (PT) exceeding the normal control range ≤ 3 seconds; (4) Adequate renal function， defined as glomerular filtration rate (GFR)\\>90mL\u002Fmin; 11.Female participants of childbearing potential have negative results on a pregancy test in 3 days before the first utilization of medicine and male or female participants with partners of child-bearing potential had to use a medically acceptable method of contraception through 180 days after taking study drug\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Patients with a history of other malignancies within the past 5 years, excluding basal cell carcinoma of the skin， cervical carcinoma in situ and\u002For thyroid papillary carcinoma have been cured;\n3. Patients who are known to be allergic to the trial drugs, finolizumab and bevacizumab；\n4. Previous history of upper gastrointestinal bleeding or current presence of a clear bleeding risk disease;\n5. Patients with uncontrolled cardiac clinical symptoms or diseases；\n6. Uncontrolled cardiac symptoms or diseases, including but not limited to (1) heart failure above NYHA class II, (2) unstable angina, (3) myocardial infarction within 1 year, and (4) clinically important significant supraventricular or ventricular arrhythmias requiring clinical intervention；\n7. Patients with any active autoimmune disease or history of autoimmune disease；\n8. Have a history of immune deficiency, including HIV-positive test results, or suffer from other acquired or congenital immune deficiency diseases, or have a history of organ transplantation and bone marrow transplantation;\n9. History of mental illness, and abuse of psychiatric drugs and narcotics;\n10. Severe uncontrolled recurrent infections or other serious uncontrolled concomitant diseases;\n11. Situations that researchers assessed as unsuitable for inclusion in this study.",{"count":442,"type":22},100,[152,25],"This study is designed to evaluate the efficacy and safety of sintilimab-bevacizumab doublet combined with FOLFOX-HAIC and TACE as the perioperative adjuvant therapy in surgical resection to hepatocellular carcinoma with high-risk features. (1) Evaluate for some high-risk patients with resectable tumours, whether or not sintilimab-bevacizumab doublet combined with FOLFOX-HAIC and TACE reduces the risk of recurrence and improves the survival of patients. (2) Evaluate the safety of sintilimab-bevacizumab doublet combined with FOLFOX-HAIC and TACE for the neoadjuvant therapy of resectable hepatocellular carcinoma.",[374],"2026-04-09",{"date":448,"type":33},"2026-04-13",{"date":450,"type":22},"2026-04-30",{"date":452,"type":22},"2028-02",{"name":454,"class":40},"BinYong Liang",{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":23,"phases":464,"briefSummary":465,"conditions":466,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":91},"100566840","phase-2-grid-radiation-therapy-for-the-treatment-of-stage-iv-non-small-cell-lung-cancer-100566840","NCT06660407","Grid Radiation Therapy for the Treatment of Stage IV Non-Small Cell Lung Cancer","Grid Radiotherapy for Advanced Non-Small Cell Lung Cancer at the Time of Progression on Immune Checkpoint Inhibition","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2\n* Stage IV non-small cell lung cancer progressing after immunotherapy or chemoimmunotherapy\n* Extracranial lesion ≥ 3 cm amenable to grid therapy\n\n  * Patients with brain metastases are permitted to enroll if all of the following are true:\n\n    * They are stable (without evidence of progression by imaging ≤ 30 days prior to enrollment and any neurologic symptoms have returned to baseline)\n    * Have no evidence of new or enlarging brain metastases, and\n    * Are not using steroids ≤ 14 days prior to enrollment\n* Patients may receive conventional palliative radiation or stereotactic body radiotherapy (SBRT) to other metastatic sites (provided there is at least one non-irradiated lesion evaluable for response)\n* Negative pregnancy test done ≤ 7 days prior to radiation therapy for females of childbearing potential only\n* Provide written informed consent\n* Willing to provide mandatory blood specimens for correlative research\n* Willing to either return to Mayo Clinic for follow-up (during the Active Monitoring Phase of the study) or willing to have virtual visits and blood draws done locally\n* Estimated by investigator to have a life expectancy \\> 3 months\n\nExclusion Criteria:\n\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Active autoimmune disease requiring systemic treatment, documented history of severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents\n\n  * NOTE: Exceptions are allowed for:\n\n    * Vitiligo\n    * Resolved childhood asthma\u002Fatopy\n    * Intermittent use of bronchodilators or inhaled steroids\n    * Daily steroids at dose of ≤ 10mg of prednisone (or equivalent)\n    * Local steroid injections\n    * Stable hypothyroidism on replacement therapy\n    * Stable diabetes mellitus on non-insulin therapy\n    * Sjogren's syndrome\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection requiring systemic therapy\n  * Interstitial lung disease\n  * Serious, chronic gastrointestinal conditions associated with diarrhea (e.g., Crohn's disease or others)\n  * Known active hepatitis B (i.e., known positive hepatitis B virus \\[HBV\\] surface antigen \\[HBsAg\\] reactive)\n\n    • Known active hepatitis C (i.e., positive for hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] detected by polymerase chain reaction \\[PCR\\])\n  * Known active tuberculosis (TB)\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Unstable cardiac arrhythmia\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements (e.g., substance abuse)\n* History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Hypersensitivity to immunotherapy\n* Previous adverse event attributed to immunotherapy that led to drug discontinuation\n* History of grade 3+ immune-related adverse event or any grade of immune-related neurologic or ocular adverse event while receiving immunotherapy\n\n  * Note: Patients who had endocrine adverse events ≤ grade 2 are allowed to enroll if they are stable on appropriate replacement therapy and asymptomatic\n* Other active malignancy \\\u003C 6 months prior to registration\n\n  * EXCEPTIONS: Non-melanotic skin cancer, papillary thyroid cancer, prostate cancer, or carcinoma-in-situ of the cervix, or others curatively treated and now considered to be at less than 30% risk of relapse\n* History of allogenic organ transplantation\n* History of active primary immunodeficiency\n* Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice)\n* Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of anti-HBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA",{"count":463,"type":22},20,[25],"This phase II trial tests the safety and effectiveness of the combination of grid radiation therapy and standard of care (SOC) immunotherapy in treating patients with stage IV non-small lung cancer (NSCLC). Conventional radiation therapy treatments typically deliver the same radiation dose to the entire tumor. Spatially fractionated radiation therapy or grid therapy is approved and a technique which permits the delivery of high doses of radiation to small regions of the tumor which can lead to enhanced tumor cell killing. Grid therapy has been shown to produce dramatic relief of severe symptoms, significant tumor regression (decrease in the size of a tumor), and above average local control rates often exceeding those expected with conventionally delivered radiation treatments, all with minimal associated toxicity. Immunotherapy has become combined into treating patients, which has led improvements in survival and quality of life. Immunotherapy is now the cornerstone of SOC therapy for stage IV NSCLC. Grid radiation therapy combined with immunotherapy may be safe and effective in treating patients with stage IV NSCLC.",[54,80],{"date":448,"type":33},{"date":469,"type":33},"2024-11-14",{"date":471,"type":22},"2027-01-10",{"name":473,"class":40},"Mayo Clinic",{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":483,"briefSummary":484,"conditions":485,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":91},"100452973","vertebroplasty-with-radiation-therapy-for-spine-metastatic-cancer-patients-with-indeterminate-lesion-sins-criteria-100452973","NCT05178472","Vertebroplasty With Radiation Therapy for Spine Metastatic Cancer Patients With Indeterminate Lesion (SINS Criteria)","Part A: Effect of Prophylactic Vertebroplasty Combined With Radiation Therapy for Spine Metastatic Cancer Patients With Indeterminate Lesion (SINS Criteria)","Inclusion Criteria:\n\n* At least 18 years of age and older with indeterminate Spine Metastasis.\n* All patients with histology that requires stereotactic RT as a part of their treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Disease visualized by CT or MRI\n* Prior radiation therapy will be allowed at the discretion of the Radiation Oncologist based on current standard operating procedures.\n* Tumor tissue from the core biopsy or resected site of disease will be collected, if available for biomarker analyses.\n* Four or less consecutive spinal segments involved by tumor. Or four or less separate spinal tumor targets with a minimum of one vertebral body separation\n* Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaire in either English or Spanish. The baseline assessment must be completed within required timelines. Inability (illiteracy in English or Spanish, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible\n\nExclusion Criteria:\n\n* Patients \\\u003C 18 years of age\n* Inability to get a standard MRI or CT myelogram for radiation treatment target delineation\n* Patients with prior radiation to the spinal segment to be treated may be included if the radiation dose can be delivered safely, per the treating radiation oncologist.\n* Patients with symptomatic spinal cord compression requiring emergent surgery\n* Pregnant or lactating women\n* Systemic therapy or immunosuppressive medications, excluding immunotherapy, within 3-14 days of radiation treatment, at the discretion of the treating radiation oncologist .\n* Patients with stable or unstable lesions based on SINS criteria",{"count":482,"type":22},200,[75],"This clinical trial studies the side effects of stereotactic radiosurgery and how well it works with or without vertebroplasty, separation surgery, or immunotherapy in patients with cancer that is radiation resistant and has spread to the spine (spinal metastases). Spinal metastases are rapidly progressive, have poor prognosis, are extremely difficult to treat, and can effect patient quality of life and overall health. Immunotherapy is a type of standard of care therapy to boost or restore the ability of the immune system to fight cancer. Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. A vertebroplasty is a procedure used to repair a bone in the spine that has a break caused by cancer, osteoporosis, or trauma. The purpose of this trial is to test different combinations of immunotherapy, stereotactic radiosurgery, and surgery to improve overall survival and quality of life in patients with spinal metastases.",[486,487,488],"Hematopoietic and Lymphoid Cell Neoplasm","Malignant Solid Neoplasm","Metastatic Malignant Neoplasm in the Spine","2026-04-03",{"date":446,"type":33},{"date":492,"type":33},"2023-03-27",{"date":494,"type":22},"2026-12-31",{"name":496,"class":40},"Ohio State University Comprehensive Cancer Center",{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":4,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":208,"enrollmentInfo":504,"targetDuration":4,"studyType":23,"phases":506,"briefSummary":507,"conditions":508,"keywords":513,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":91},"100571395","phase-2-concurrent-chemoradiotherapy-combined-with-toripalimab-and-surufatinib-in-the-treatment-of-limited-stage-small-cell-lung-cancer-100571395","NCT06719700","Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer","A Prospective Phase II Study of Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Informed Consent: An informed consent form, signed and dated, must be provided before any steps in the study are performed.\n* Age: Males or females aged 18 to 75 years.\n* Diagnosis: Histologically or cytologically confirmed small cell lung cancer (SCLC).\n* Stage: Stage I-III (AJCC\u002FUICC 8th edition TNM staging), where all lesions can be included in a single radical radiotherapy plan (i.e., limited-stage disease). Stage I-II must be inoperable.\n* Life Expectancy: ≥12 weeks.\n* Performance Status (PS): WHO PS score of 0 or 1.\n* Postmenopausal women or those with a negative urine or serum pregnancy test (HCG sensitivity ≥25 IU\u002FL or equivalent) within 7 days before starting study treatment.\n* Female participants must not be breastfeeding.\n* Women of childbearing potential (WOCBP) must agree to use contraception during study treatment and for 3 months after the last dose of study drug (i.e., 30 days for an ovulation cycle plus approximately 5 half-lives of the investigational drug).\n* Male participants engaging in sexual activity with WOCBP must agree to use contraception during study treatment and for 5 months after the last dose of study drug (i.e., 90 days for sperm regeneration cycle plus approximately 5 half-lives of the investigational drug).\n* Males with azoospermia do not need to follow contraception requirements.\n* WOCBP who are not sexually active do not need to follow contraception requirements but must still undergo pregnancy testing as outlined.\n* Organ and Bone Marrow Function:\n\nPulmonary Function: FEV1 ≥800 mL. Absolute neutrophil count ≥1.5 × 10⁹\u002FL. Platelet count ≥100 × 10⁹\u002FL. Hemoglobin ≥9.0 g\u002FdL. Renal Function: Calculated creatinine clearance ≥50 mL\u002Fmin using the Cockcroft-Gault formula.\n\nSerum bilirubin ≤1.5 × upper limit of normal (ULN). AST and ALT ≤2.5 × ULN.\n\nExclusion Criteria:\n\n* Participation in Another Clinical Trial: Simultaneous participation in another clinical trial, unless it is an observational (non-interventional) study.\n* Mixed Histology: Histological subtype of mixed small cell and non-small cell lung cancer (SCLC).\n* Extensive-Stage SCLC: Diagnosis of extensive-stage SCLC.\n* Malignant Effusions: Pathologically confirmed malignant pleural effusion or pericardial effusion.\n* Hemoptysis: Central cavitary SCLC with hemoptysis (hemoptysis volume \\>50 ml\u002Fday).\n* Immunosuppressive Treatment: Use of immunosuppressive drugs within 28 days prior to the first dose of toripalimab. Physiological doses of intranasal corticosteroids and systemic corticosteroids ≤10 mg daily of prednisone (or equivalent) are exceptions. Steroids used to manage chemoradiotherapy-related toxicities are allowed.\n* Previous Anti-PD-1\u002FPD-L1 Therapy: Prior use of any anti-PD-1 or anti-PD-L1 antibodies.\n* Major Surgery: Underwent major surgery (excluding vascular access) within 4 weeks before study entry.\n* Autoimmune Disease History: History of autoimmune diseases within the last 2 years, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis.\n* Primary Immunodeficiency: History of primary immunodeficiency.\n* Organ Transplant History: History of organ transplantation requiring immunosuppressive treatment.\n* QT Interval Prolongation: QTc interval (corrected by Bazett's formula) \\>470 ms, calculated from three ECG measurements.\n* Uncontrolled Comorbidities: Uncontrolled comorbid conditions, including but not limited to persistent or active infections, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, arrhythmias, active peptic ulcer disease or gastritis, active bleeding disorders, chronic hepatitis C, HIV infection, HBsAg-positive patients with DNA \\>500 IU\u002Fml, or any psychiatric or social conditions that may interfere with study requirements or the patient's ability to provide informed consent.\n* Tuberculosis History: Known history of tuberculosis.\n* Live Vaccination: Received a live attenuated vaccine within 30 days prior to study initiation.\n* Previous Primary Malignancy: History of another primary malignancy within 5 years prior to study entry, except for adequately treated basal or squamous cell carcinoma of the skin, in situ cervical cancer, ductal carcinoma in situ of the breast, or localized prostate cancer.\n* Pregnancy and Breastfeeding: Pregnant or breastfeeding women, or men and women of reproductive potential who are not using effective contraception.\n* Interference with Study Assessment: Any condition that may interfere with the evaluation of toripalimab's efficacy or safety.\n* Investigator's Discretion: Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.",{"count":505,"type":22},47,[25],"Based on the preclinical rationale for combining surufatinib with immunotherapy, and the clinical efficacy observed with surufatinib in extensive-stage small cell lung cancer (ES-SCLC), the investigators hypothesize that incorporating surufatinib into the ADRIATIC regimen could further enhance survival in LS-SCLC. To evaluate this approach, the investigators plan to conduct a single-arm Phase II study to explore the safety and efficacy of concurrent chemoradiotherapy combined with toripalimab and surufatinib in treating LS-SCLC.",[509,510,511,512],"Toripalimab","Surufatinib","Chemoradiotherapy","Limited-stage Small Cell Lung Cancer (LS-SCLC)",[509,510,511,514,515],"Limited-stage small cell lung cancer (LS-SCLC)","Immunotherapy consolidation","2026-02-28",{"date":518,"type":33},"2026-03-03",{"date":520,"type":33},"2024-11-30",{"date":522,"type":22},"2028-11-29",{"name":524,"class":40},"Sun Yat-sen University",{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":23,"phases":533,"briefSummary":534,"conditions":535,"keywords":537,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":545,"locationsCount":91},"100624248","efficacy-of-first-line-immunotherapy-in-metastatic-melanoma-in-slovenia-and-identification-of-predictive-biomarkers-100624248","NCT07407166","Efficacy of First-Line Immunotherapy in Metastatic Melanoma in Slovenia and Identification of Predictive Biomarkers","Efficacy of Immunotherapy in the First Line of Treatment of Diffuse Melanoma in Slovenia and Recognition of Prognostic and Predictive Biomarkers From Primary Tumor, Faeces and Body Fluids","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Metastatic (diffuse) melanoma\n* Planned first-line immunotherapy treatment\n* Signed informed consent for participation in the study\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Inability to provide informed consent\n* Any condition preventing participation or sample collection according to investigator judgment",{"count":319,"type":22},[75],"This study evaluates the effectiveness of first-line immunotherapy in patients with metastatic melanoma treated at the Institute of Oncology Ljubljana in Slovenia. The main objectives are to assess treatment response rates, progression-free survival, and treatment safety, and to identify prognostic and predictive biomarkers associated with response to immunotherapy.\n\nBiological samples including blood, stool, and body fluids (if available) will be collected at predefined time points and analyzed for molecular tumor markers. Imaging assessments (CT or PET\u002FCT) will be performed before treatment initiation and during follow-up to evaluate response.\n\nThe study aims to improve identification of patient subgroups who benefit from immunotherapy and those who do not, supporting better personalized treatment strategies.",[536,28],"Metastatic Melanoma",[350,538],"First-Line Treatment","2026-02-12",{"date":541,"type":33},"2026-02-17",{"date":543,"type":33},"2021-05-01",{"date":37,"type":22},{"name":546,"class":40},"Institute of Oncology Ljubljana",{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":244,"enrollmentInfo":554,"targetDuration":4,"studyType":23,"phases":555,"briefSummary":556,"conditions":557,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":91},"100588579","phase-2-study-of-probiotics-combined-with-concurrent-hyperfractionated-chemoradiotherapy-and-adebrelimab-immunomaintenance-in-the-treatment-of-limited-stage-small-cell-lung-cancer-ls-sclc-100588579","NCT06943235","Study of Probiotics Combined With Concurrent Hyperfractionated ChemoRadiotherapy and Adebrelimab Immunomaintenance in the Treatment of Limited-stage Small Cell Lung Cancer (LS-SCLC)","A Prospective, Multicenter, Randomized Controlled, Phase II Study of Probiotics Combined With Concurrent Hyperfractionated ChemoRadiotherapy and Adebrelimab Immunomaintenance in the Treatment of Limited-stage Small Cell Lung Cancer (LS-SCLC)","Inclusion Criteria:\n\n1. Sign written informed consent before implementing any experimental procedures;\n2. Age range: 18-80 years old;\n3. Pathological diagnosis of small cell lung cancer;\n4. Limited stage;\n5. ECOG PS 0-1；\n6. Receive ≤ 2 rounds of chemotherapy or chemotherapy plus immunotherapy;\n7. Expected survival time\\>3 months;\n\nExclusion Criteria:\n\n1. Progress after 2 induction treatments;\n2. Severe emphysema, interstitial changes in the lungs, COPD patients;\n3. Resting blood oxygen\\\u003C93;\n4. Have a history of other malignant tumors and have received chemotherapy in the past 3 years;\n5. History of chest radiotherapy;",{"count":277,"type":22},[25],"ADRIATIC study explored the benefits of immune maintenance therapy after LS-SCLC radiotherapy and chemotherapy. In the presence of immunotherapy, is it necessary to increase the dosage of radiotherapy and can it further improve the efficacy? This study aims to explore the efficacy and safety of simultaneous integrated boost hyperfractionation radiotherapy combined with probiotics and Adalberg monoclonal antibody consolidation therapy for small cell lung cancer.",[558],"Limited Stage Small Cell Lung Cancer","2026-02-08",{"date":561,"type":33},"2026-02-11",{"date":563,"type":33},"2025-04-25",{"date":565,"type":22},"2027-12-30",{"name":567,"class":40},"Fudan University",{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":576,"enrollmentInfo":577,"targetDuration":4,"studyType":23,"phases":579,"briefSummary":580,"conditions":581,"keywords":583,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":598},"100578385","phase-2-immunochemotherapy-surgery-or-chemoradiation-and-durvalumab-for-stage-iiiab-nsclc-100578385","NCT06810609","Immunochemotherapy, Surgery or Chemoradiation, and Durvalumab for Stage IIIA\u002FB NSCLC","Prospective Randomized Phase II Trial on Induction Immunochemotherapy Followed by Surgery or Definitive Chemoradiation and Consolidation Durvalumab (MEDI4736) in Resectable and Borderline Resectable Stage IIIA\u002FB NSCLC","InDuRanS","Inclusion Criteria:\n\n1\\. Patient is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (European Union \\[EU\\] Data Privacy Directive in the EU) obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations.\n\n2\\. Patient is willing and able to comply with the protocol for the duration of the study 3. Age ≥ 18 years and \\\u003C 75 years. 4. All sex and gender. 5. Female patients of childbearing potential as well as male patients with partners of childbearing potential must agree to always use a highly effective form of contraception according to the Clinical Trials Facilitation and Coordination Group (CTFG) during the course of this study and for at least 90 days after the last dose of durvalumab or 6 months after the last dose of chemotherapy, whichever occurs last.\n\n6\\. Evidence of post-menopausal status or negative serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause.\n\n7\\. Histologically and \u002F or cytologically proven NSCLC (EGFRm-, ALK-). 8.\n\nSelected patients with NSCLC stage IIIA\u002FB:\n\n1. IIIA: one or more lymph node levels involved at EBUS\u002Fmediastinoscopy T1\u002FT2 N2.\n2. IIIB: one or more lymph node levels involved at EBUS\u002Fmediastinoscopy T3\u002FT4 N2. 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 10. Given technical\u002Foncologic complete resectability (R0) at the time of inclusion. 11. Sufficient functional reserves for the planned surgery 12. Fulfilment of adequate criteria for functional and medical resectability as described in the European Respiratory Society (ERS)\u002F European Society of Thoracic Surgeons (ESTS) guidelines (Brunelli et al. 2009) and acceptable general clinical condition for multimodality treatment (interdisciplinary committee).\n\n   13\\. Life expectancy of \\> 12 weeks. 14. Body weight \\> 30 kg. 15.\n\n   Adequate normal organ and bone marrow function as defined below:\n\na. Hemoglobin ≥ 9.0 g\u002FdL. b. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL. c. Platelet count ≥ 100 × 109\u002FL. d. Serum bilirubin ≤ 1.5 × institutional upper limit of normal (ULN). (This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\n\ne. Alanine aminotransferase (ALT\u002FSGPT) and aspartate aminotransferase (AST\u002FSGOT) ≤ 2.5 × institutional ULN.\n\nf. Measured creatinine clearance (CL) ≥ 60 mL\u002Fmin or calculated creatinine CL ≥ 60 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance.\n\n16\\. Stable cardiac function (no myocardial infarction (MI) within 6 months, no heart failure NYHA III-IV).\n\n17\\. Discussion in a multidisciplinary tumor board which supports participation in this clinical trial, indicating that both chemoradiotherapy and surgery are possible local treatments.\n\nPatients should only be randomized if all of the following inclusion criteria are fulfilled at the time of randomization:\n\n1. Given technical\u002Foncologic complete resectability (R0) at the time of randomization.\n2. Sufficient functional reserves for the planned surgery\n3. Adequate normal organ and bone marrow function as defined before\n\n   Exclusion Criteria:\n\n1\\. Unresectable disease. 2. Mixed histology with areas of small cell carcinoma (neuroendocrine markers). 3. ALK+\u002F EGFRm disease. 4. Clinically symptomatic vena cava superior syndrome. 5. Diffuse mediastinal involvement. 6. Patients with N3 tumors (IASLC\u002FUICC 8). 7. Invasion of the thoracic aorta (T4 - aorta) or the heart (except left atrium - T4 - heart) or the esophagus (T4 - esophagus), or invasion of spine (T4 - spine) NOTE: T4 with invasion of diaphragm are eligible. 8. Pancoast-syndrome in tumors of the superior sulcus (T3-4 Nx). 9. Metastatic disease (M1). 10. Endobronchial tumor extension to the contralateral main stem bronchus. 11. Lung or heart function not allowing the intended surgical procedure at the time of inclusion.\n\n12\\. Prior treatments including prior mediastinal irradiation. 13. Insufficient patients' compliance (e.g., symptomatic psychiatric disorder) or missing written informed consent or definitive refusal for participation.\n\n14\\. Prior randomization of treatment in a previous durvalumab clinical study regardless of treatment arm assignment.\n\n15\\.\n\nPatients who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4:\n\n1. Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n2. All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.\n3. Must not have experienced a ≥ Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy.\n\n   NOTE: Patients with endocrine AE of ≤ Grade 2 are permitted to be enrolled if they are stably maintained on appropriate replacement therapy and are asymptomatic.\n4. Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of \\> 10 mg prednisone or equivalent per day.\n\n   16\\. Participation in another clinical study with an investigational product during the last 12 months.\n\n   17\\. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n\n   18\\. History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest CT scan.\n\n   19\\. Any concurrent chemotherapy (other than study therapy), Investigational Product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n\n   20\\. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of durvalumab.\n\n   21\\. History of allogenic organ transplantation or a stem cell transplantation. 22.\n\n   Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). The following are exceptions to this criterion:\n\na. Vitiligo or alopecia b. Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement c. Any chronic skin condition that does not require systemic therapy d. Celiac disease controlled by diet alone e. Patients without active disease in the last 5 years may be included but only after consultation with the study physician 23. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n\n24\\. History of another primary malignancy except for\n\na. Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of durvalumab and of low potential risk for recurrence b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease c. Adequately treated carcinoma in situ without evidence of disease 25. History of active primary immunodeficiency. 26. History of leptomeningeal carcinomatosis. 27. Known active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B, hepatitis C, or human immunodeficiency virus (positive HIV-1 or HIV-2). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n\n28\\.\n\nCurrent or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:\n\n1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n2. Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) 29. Current or prior use of immunostimulatory agents within 14 days before the first dose of durvalumab 30. Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab. Note: Patients, if enrolled, should not receive live vaccine whilst receiving study treatment and up to 90 days after the last dose of study treatment.\n\n   31\\. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab or 6 months after the last dose of chemotherapy, whichever occurs last.\n\n   32\\. Known allergy or hypersensitivity to any of the study drugs or any of the study drugs excipient.\n\n   33\\. Any medical contraindication to treatment with platin-based doublet chemotherapy as listed in the applying SmPCs.\n\n   34\\. Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.\n\n   Patients should not be randomized if any of the following exclusion criteria are fulfilled at the time of randomization:\n\n   1\\. Complete remission after induction immunochemotherapy. 2.\n\n   Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous immunochemotherapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria:\n\na. Patients with Grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.\n\nb. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician (exception: alopecia).\n\n3\\. Allergy or hypersensitivity to durvalumab or concurrent chemotherapy drugs or any excipient appearing for the first time during previous immunochemotherapy.","74 Years",{"count":578,"type":22},176,[25],"The hypothesis of the study is that induction immunochemotherapy, followed by surgery or chemoradiation and consolidation Durvalumab immunotherapy, can significantly improve event-free survival in patients with resectable or borderline resectable NSCLC at stage IIIA\u002FB compared to existing treatment methods.",[582],"Lung Cancer Non-Small Cell Cancer (NSCLC)",[574,584,585,586,587,588],"Non-Small Cell Lung Cancer","Chemoradiation","Resectable NSCLC","Durvalumab","Induction Immunochemotherapy","2026-01-25",{"date":591,"type":33},"2026-01-27",{"date":593,"type":33},"2025-04-20",{"date":595,"type":22},"2030-09-30",{"name":597,"class":40},"University Hospital, Bonn",5,{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":605,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":607,"targetDuration":4,"studyType":23,"phases":608,"briefSummary":609,"conditions":610,"keywords":613,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":623,"locationsCount":141},"100514415","phase-2-radiotherapy-combined-with-immunochemotherapy-in-metastatic-esophageal-squamous-cell-carcinoma-100514415","NCT05978193","Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma","First-line Anti-PD-1 Therapy Plus Chemotherapy With or Without Radiotherapy in Metastatic Esophageal Squamous Cell Carcinoma: A Phase II Multi-center Trial (SCR-ESCC-01)","SCR-ESCC-01","Inclusion Criteria:\n\n1. Age ≥18;\n2. Metastatic esophageal squamous cell carcinoma (stage IVB, M1) confirmed by pathology;\n3. ECOG performance status: 0-1 point;\n4. No prior anti-tumor treatment;\n5. Adequate hematologic, renal, hepatic, and cardiac functions that meet the requirements for chemotherapy and immunotherapy assessed by investigators.\n\nExclusion Criteria:\n\n1. Non-squamous cell esophageal carcinoma or ESCC mixed with other pathological types of esophageal cancer;\n2. Patients who are potentially curable with surgery as assessed by investigators;\n3. Pleural metastasis or malignant pleural effusion, pericardial effusion;\n4. Any prior anti-tumor therapy for esophageal cancer, i.e., surgery, radiotherapy, chemotherapy, or immunotherapy;\n5. High risk of gastrointestinal bleeding, esophageal fistula, or perforation;\n6. Patients with Patient-Generated Subjective Globe Assessment (PG-SGA) score≥9;\n7. Unstable cardiac diseases or symptoms;\n8. History of interstitial pulmonary disease, non-infectious pneumonitis; pulmonary fibrosis, or other uncontrolled acute pulmonary disease;\n9. Active autoimmune disease or history of autoimmune disease;\n10. Conditions of immunodeficiency or active infection requiring systemic therapy;\n11. Pregnant or breastfeeding;\n12. Patients with synchronous second primary cancer and a history of malignancy within the past 5 years (excluding completely cured cervical carcinoma in situ or basal cell or squamous cell skin carcinoma).",{"count":442,"type":22},[25],"SCR-ESCC-01 is a multicenter, randomized, phase II study aiming to investigate the benefit of early involvement of low-dose radiotherapy(LDRT) and conventionally fractionated radiotherapy(CFRT) in the first-line anti-PD-1 based treatment of metastatic ESCC. It begins with a safety run-in phase, followed by a randomized controlled comparison against standard immunochemotherapy.",[611,301,612],"Esophageal Squamous Cell Carcinoma","Metastatic Esophageal Squamous Cell Carcinoma",[350,614,615,616],"low-dose radiotherapy","Esophageal squamous cell carcinoma","Immunoradiotherapy","2026-01-20",{"date":619,"type":33},"2026-01-22",{"date":621,"type":33},"2023-01-01",{"date":431,"type":22},{"name":624,"class":40},"Shanghai Chest Hospital",{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":4,"eligibilityCriteria":631,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":632,"targetDuration":4,"studyType":23,"phases":634,"briefSummary":635,"conditions":636,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":647,"locationsCount":91},"100425581","phase-3-neoadjuvant-treatment-modalities-in-esophageal-cancer-100425581","NCT04821843","Neoadjuvant Treatment Modalities in Esophageal Cancer","Cohort Study of Neoadjuvant Treatment Modalities for Esophageal Cancer","Inclusion Criteria:\n\n* ≥18 years；\n* Esophageal or Esophagogastric cancer；\n* Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as I-IVa (AJCC 8th)；\n* Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences；\n* ECOG PS score: 0\\~1；\n* Estimated survival time ≥3 months；\n* Normal organ and marrow function as defined below:Hemoglobin: greater than or equal to 100g\u002FL ;Leukocytes: greater than or equal to 4,000 G\u002FL; Neutrophil: greater than or equal to 2,000 G\u002FL; Platelets: greater than or equal to 100,000\u002Fmm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml\u002Fmin; AST\u002FALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit；\n* Informed consent；\n\nExclusion Criteria:\n\n* With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc；\n* Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer；\n* Existing active infection such as active tuberculosis and hepatitis；\n* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia；\n* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness History of allergic reactions attributed to paclitaxel, albumin or cisplatin；\n* Participation in other clinical trials currently or within 4 weeks of selection；\n* Pregnant or lactating females；\n* Absence of medical records.",{"count":633,"type":22},2000,[248],"Esophageal cancer is the most prevalent cancer globally with poor survival outcome. The prognosis with surgery alone is poor, accounting for 30-40% of overall survival at 5 year. Either neoadjuvant chemotherapy (nCT) or chemoradiotherapy (nCRT) has been shown as efficatious therapy to improve patients outcomes in esophageal or esophagogastric junction cancer as compared with surgery alone. The purpose of this study was to explore the optimal neoadjuvant treatment modalities including PD-1\u002FPD-L1 antibody or targeted drug for patients with esophageal or esophagogastric junction cancer.",[301,637,585,638,639,350,640],"Chemotherapy Effect","Surgery","Targeted Therapy","Esophagogastric Juction Cancer","2026-01-18",{"date":643,"type":33},"2026-01-21",{"date":645,"type":33},"2002-01-01",{"date":266,"type":22},{"name":648,"class":40},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",""]