[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cancer Institute and Hospital, Chinese Academy of Medical Sciences\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":595},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,223,0,25,[9,43,66,88,112,139,169,189,209,234,257,289,317,342,367,386,407,431,449,469,497,518,537,559,577],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100652503","establishment-of-a-multi-omics-prediction-model-for-early-triple-negative-breast-cancer-based-on-upgrade-tnbc-study-100652503",false,"NCT07773818","Establishment of a Multi-omics Prediction Model for Early Triple-negative Breast Cancer Based on UPGRADE-TNBC Study","Inclusion Criteria:\n\n* The UPGRADE-TNBC Study Population\n\nExclusion Criteria:\n\n* Populations outside the UPGRADE-TNBC study","FEMALE","18 Years","75 Years",{"count":20,"type":21},32,"ESTIMATED","2 Years","OBSERVATIONAL","Based on the UPGRADE-TNBC study, a high-quality TNBC sample repository was established. By integrating multi-source data-including clinical information, radiomics, pathological images, and molecular sequencing-and innovatively incorporating a meta-learning strategy, a treatment response prediction model based on multimodal small-sample learning was developed. This approach aims to optimize drug combinations and precisely identify patient subgroups likely to benefit from treatment, thereby providing a new paradigm for personalized therapy in early-stage TNBC.",[26,27,28,29],"Triple -Negative Breast Cancertriple","Meta-Learning","Predictive Models","Multimodal","RECRUITING","2026-08-16",{"date":33,"type":34},"2026-08-19","ACTUAL",{"date":36,"type":34},"2026-08-06",{"date":38,"type":21},"2029-09-01",{"name":40,"class":41},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100592444","real-world-study-of-skb264-monotherapy-or-combination-therapy-in-recurrent-or-metastatic-her2-negative-breast-cancer-100592444","NCT06993506","Real-world Study of SKB264 Monotherapy or Combination Therapy in Recurrent or Metastatic HER2-negative Breast Cancer","Sacituzumab Tirumotecan Monotherapy or Combination Therapy in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HER2-Negative Breast Cancer: A Real-World Study","Inclusion Criteria:\n\n1. Aged ≥ 18 years old at the time of signing the informed consent form, regardless of gender;\n2. Patient must meet one of the following pathological diagnoses and classifications:\n\n   2.1) For TNBC Cohort: -Histological\u002Fcytological confirmed of triple-negative breast cancer (TNBC) from the most recent pre-SKB264 biopsy\u002Fpathological report, with: HER2 negative: immunohistochemistry (IHC) of 0 or 1+; if is 2+ by IHC, negative HER2 expression must be confirmed by fluorescence in situ hybridization (FISH); Estrogen and progesterone receptor negative means that less than 1% of the cells express hormone receptors as indicated by IHC; -Locally advanced, recurrent, or metastatic disease (locally advanced disease should be confirmed by investigators as ineligible for curative resection); 2.2) For HR+\u002FHER2- BC Cohort: -Histological\u002Fcytological confirmed of HR+\u002FHER2- breast cancer from the most recent pre-SKB264 biopsy\u002Fpathological report, with: HER2 negative: IHC of 0 or 1+; if is 2+ by IHC, negative HER2 expression must be confirmed by FISH; HR positive: Hormone receptor-positive (HR, ER, or PR status) was defined as ≥1% expression by IHC.-Locally advanced, recurrent, or metastatic disease (locally advanced disease should be confirmed by investigators as ineligible for curative resection);\n3. Plan to receive SKB264 monotherapy or combination therapy;\n4. Prior treatment lines: -For TNBC Cohort: ≤2 lines of systemic antitumor therapy for unresectable locally advanced, recurrent, or metastatic disease; -For HR+\u002FHER2- BC Cohort: ≤2 lines of systemic antitumor therapy (excluding endocrine therapy) for unresectable locally advanced, recurrent, or metastatic disease;\n5. Voluntarily participate in the study, sign the informed consent form and demonstrate good compliance.\n\nExclusion Criteria:\n\n1. Patients with other malignancies, except cured basal or squamous cell skin cancer or in situ cancer of cervix; and patients with other malignancies must have a tumor-free period of at least 5 years;\n2. Patients who are currently participating in other interventional clinical studies;\n3. Known allergy to the investigational drug or any of its components;\n4. Pregnant or lactating women;\n5. Any situation that the researchers consider to interfere with the evaluation of the study drug or the safety of the subjects or the analysis of the study results, or any other situation that the researchers consider inappropriate to participate in this study.","ALL",{"count":52,"type":21},500,"This study is a multi-center observational real-world study, with a total of 500 patients planned to be enrolled. This study is divided into two cohorts: the triple-negative breast cancer (TNBC) cohort and the hormone receptor-positive\u002Fhuman epidermal growth factor receptor 2-negative breast cancer (HR+\u002F HER2-BC) cohort. The aim of this study is to assess the efficacy and safety of Sacituzumab Tirumotecan (SKB264) monotherapy or combination therapy in patients with unresectable locally advanced, recurrent or metastatic HER2-negative breast cancer in the real-world setting.",[55,56,57],"HER2-negative Breast Cancer","Recurrence","Metastasis",{"date":59,"type":34},"2026-08-18",{"date":61,"type":34},"2026-05-28",{"date":63,"type":21},"2027-10-31",{"name":40,"class":41},19,{"id":67,"slug":68,"hasResults":12,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":4},"100651484","colors-validate-study-of-decision-support-software-for-surgical-sequencing-in-colorectal-liver-metastases-100651484","NCT07760558","COLORS-Validate Study of Decision-Support Software for Surgical Sequencing in Colorectal Liver Metastases","Clinical Utility Evaluation of a Surgical Sequencing Decision-Support Software in Simulated Cases of Colorectal Liver Metastases: A Multicenter Prospective Study (COLORS-Validate Study)","Inclusion Criteria:\n\n* Licensed physicians specializing in hepatobiliary surgery or colorectal surgery\n* At least 1 year of clinical experience after graduation\n* Willing to participate in the simulation-based decision-making study\n* Practicing at one of the participating tertiary academic hospitals\n\nExclusion Criteria:\n\n* Not actively involved in clinical surgical decision-making\n* Unable to complete all required simulation sessions\n* Prior involvement in the development of the decision-support software",true,{"count":75,"type":21},12,"This study evaluates a surgical decision-support software designed to assist physicians in selecting the optimal surgical sequence for patients with colorectal cancer liver metastases.\n\nIn this multicenter prospective simulation study, participating surgeons from multiple centers will review standardized clinical case scenarios. For each case, physicians will first make a surgical sequencing decision based on their own clinical judgment. They will then review the recommendation provided by the decision-support software and make a second decision if they choose to revise their initial plan.\n\nThe study will assess whether the software influences clinical decision-making, including changes in surgical strategy, decision confidence, decision time, and agreement with software recommendations. Physician user experience will also be evaluated using standardized questionnaires, including system usability and cognitive workload scales.\n\nThe goal of this study is to determine the clinical utility and usability of the decision-support software in improving surgical decision-making consistency and supporting clinical reasoning in colorectal liver metastases cases.",[78],"Colorectal Liver Metastases","NOT_YET_RECRUITING","2026-08-10",{"date":82,"type":34},"2026-08-12",{"date":84,"type":21},"2026-09-01",{"date":86,"type":21},"2026-10-30",{"name":40,"class":41},{"id":89,"slug":90,"hasResults":12,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":18,"enrollmentInfo":95,"targetDuration":4,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":42},"100650528","phase-2-shr-1701-plus-apatinib-for-second-line-treatment-in-targeted-immune-pretreated-advanced-hepatocellular-carcinoma-100650528","NCT07749859","SHR-1701 Plus Apatinib for Second-Line Treatment in Targeted-Immune Pretreated Advanced Hepatocellular Carcinoma","An Exploratory Clinical Study of SHR-1701 Combined With Apatinib as Second-Line Therapy in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Targeted and Immune Therapies","Inclusion Criteria:\n\n1. Aged 18-75 years, male or female; signed informed consent form with good compliance;\n2. Patients with histologically confirmed hepatocellular carcinoma or meeting clinical diagnostic criteria, currently unresectable or metastatic;\n3. Prior receipt of first-line combined targeted and immunotherapy with subsequent disease progression or intolerance;\n4. At least one measurable lesion meeting the criteria of RECIST v1.1;\n5. ECOG performance status of 0 or 1;\n6. Expected survival ≥ 12 weeks;\n7. Child-Pugh Class A (score 5-6);\n8. Adequate organ and bone marrow function as defined below (tested within 14 days prior to initiation of study treatment):\n\n1)Hematology laboratory values (no blood transfusion, granulocyte colony-stimulating factor \\[G-CSF\\], or corrective hematologic agents administered within 14 days before screening): A. Hemoglobin (Hb) ≥ 90 g\u002FL; B. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; C. Platelet count (PLT) ≥ 75 × 10⁹\u002FL; 2)Serum chemistry laboratory values (no albumin transfusion within 14 days before screening): A. Total serum bilirubin (BIL) ≤ 2 × ULN (≤ 3 × ULN for patients with Gilbert syndrome); B. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN;\n\nC. For patients with liver metastases, ALT and AST ≤ 5 × ULN; serum creatinine (Cr) ≤ 1.5 × ULN OR endogenous creatinine clearance ≥ 50 mL\u002Fmin (calculated via the Cockcroft-Gault formula):\n\nMale: Creatinine clearance = \\[(140 - age) × body weight\\] \u002F (72 × serum Cr); Female: Creatinine clearance = \\[(140 - age) × body weight\\] \u002F (72 × serum Cr) × 0.85(Body weight in kg; serum Cr in mg\u002FdL) 9.Controllable proteinuria and blood pressure: urine protein \\\u003C2+ (or 24-hour urinary protein \\\u003C1.0 g, or urine protein\u002Fcreatinine ratio \\[UPC\\] \\\u003C1.0); systolic blood pressure ≤140 mmHg and diastolic blood pressure ≤90 mmHg (achievable with antihypertensive medications); 10.Evaluation of portal hypertension and varices: esophagogastroduodenoscopy (EGD) performed within 6 months prior to enrollment; patients with medium-to-high risk esophageal and gastric varices must have completed prophylactic treatment per guidelines (e.g., endoscopic variceal ligation \\[EVL\\]\u002Fnon-selective beta-blockers \\[NSBB\\]), and study treatment shall be initiated no earlier than 14 days after EVL; 11.Hepatitis B and C criteria: For subjects with positive HBsAg or HBcAb, HBV-DNA shall be below the lower limit of quantification, and nucleos(t)ide antiviral therapy shall be initiated and administered throughout the study period. Subjects with HCV infection shall have stable virological status (either receiving DAA therapy or previously cured); 12.Fertility requirements: Fertile subjects agree to use reliable contraception from enrollment until 6 months after the last study drug administration, with a negative pregnancy test prior to enrollment; 13.Recovery from prior therapies: All toxicities related to previous anti-tumor therapies have recovered to Grade 1 or baseline levels (except acceptable alopecia, stable hypoendocrine function, etc.). At least 3 weeks have elapsed since the last systemic anti-tumor therapy, at least 4 weeks since major surgery, and at least 4 weeks since local therapy (TACE, RFA, etc.) with stable recovery.\n\nExclusion Criteria:\n\n1. History of severe hypersensitivity or irreversible toxic reactions to similar PD-L1 agents or VEGFR-2 TKIs;\n2. Child-Pugh Class B or C, refractory ascites requiring paracentesis at least weekly, Grade ≥2 hepatic encephalopathy, or MELD score \\>12 (optional, subject to institutional SOPs);\n3. High bleeding risk: Grade ≥3 gastrointestinal hemorrhage, perforation, active ulcer or uncontrolled bleeding diathesis within the past 6 months; untreated medium-to-large varices or high-risk signs identified on EGD without completed prophylactic intervention; clinical indication for potent anticoagulants or dual antiplatelet therapy that cannot be discontinued or substituted (aspirin ≤100 mg daily may be permitted at the Investigator's discretion);\n4. Prior treatment with apatinib or PD-L1 monoclonal antibody immune checkpoint inhibitors;\n5. Uncontrolled hypertension (persistent blood pressure ≥140\u002F90 mmHg despite medical treatment), persistent proteinuria ≥2+ or uncorrected 24-hour urinary protein ≥1.0 g;\n6. Severe cardiovascular diseases: myocardial infarction (MI), unstable angina, NYHA Class III-IV heart failure, clinically significant arrhythmia, QTcF interval ≥470 ms within the preceding 6 months, or recent arterial\u002Fvenous thromboembolic events;\n7. Recent surgical procedures or unhealed wounds: major surgery performed within 4 weeks prior to enrollment with unhealed incision; gastrointestinal perforation or fistula occurring within 6 months prior to enrollment;\n8. Active infections: bacterial or fungal infections requiring intravenous antibiotics, active tuberculosis; high HBV-DNA replication without antiviral therapy initiated; uncontrolled HIV infection (e.g., CD4 count \\\u003C200\u002FμL or detectable viral load) or history of opportunistic infections;\n9. Active autoimmune disease or immunodeficiency requiring systemic immunosuppressive therapy (prednisone equivalent \\>10 mg daily). The following subjects may be eligible: stable hypothyroidism on replacement therapy, type 1 diabetes mellitus, localized cutaneous vitiligo\u002Fpsoriasis, and inflammatory bowel disease in remission without need for systemic immunosuppression (at the Investigator's discretion);\n10. Prior severe immune-related adverse events (irAEs ≥ Grade 3, such as severe pneumonitis, colitis, hepatitis, neuromuscular disorders, myocarditis, etc.) or recurrent irAEs requiring long-term immunosuppression.\n11. Symptomatic central nervous system metastases or metastases requiring glucocorticoid control; asymptomatic lesions stable for ≥4 weeks may be considered for enrollment (per institutional policy).\n12. History of other malignant tumors within the past 3 years, excluding cured basal\u002Fsquamous cell skin carcinoma, cervical carcinoma in situ, or other cured low-risk malignancies.\n13. Pregnancy or breastfeeding; hypersensitivity to any component of the study drugs.",{"count":96,"type":21},80,"INTERVENTIONAL",[99],"PHASE2","This clinical study aims to evaluate the efficacy and safety of Retlirafusp alfa Injection (SHR-1701) combined with apatinib in patients with advanced hepatocellular carcinoma (HCC) who have experienced disease progression after first-line targeted combined immunotherapy, and provide clinical evidence for the second-line treatment of advanced HCC. A total of 80 patients with radiologically or pathologically confirmed advanced\u002Funresectable hepatocellular carcinoma with disease progression after prior first-line targeted-immunotherapy will be enrolled within 2.5 years. All enrolled patients will receive intravenous infusion of SHR-1701 at 30 mg\u002Fkg every 3 weeks in combination with oral apatinib 250 mg once daily; treatment will be maintained until disease progression or intolerable adverse toxicity occurs. The primary study endpoint is objective response rate (ORR).",[102],"Advanced Unresectable Hepatocellular Carcinoma",[104],"Hepatocellular carcinoma, SHR-1701, Apatinib, Second-line therapy","2026-08-03",{"date":36,"type":34},{"date":108,"type":21},"2026-08",{"date":110,"type":21},"2028-12",{"name":40,"class":41},{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":18,"enrollmentInfo":119,"targetDuration":4,"studyType":97,"phases":121,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100527375","safety-of-mid-and-low-rectal-cancer-surgery-without-dissection-of-the-no253-lymph-node-s-m-o-o-t-h-100527375","NCT06146946","Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node (S-M-O-O-T-H)","Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node, a Prospective, Multicenter, Non-inferior Randomized Controlled Trial","Inclusion Criteria:\n\n1. Patient age between 18-75 years.\n2. Colonic biopsy pathology confirms adenocarcinoma.\n3. At initial treatment, colonoscopy and imaging diagnose the tumor's lower edge as less than or equal to 7cm from the anus.\n4. At initial treatment, imaging diagnoses the tumor T stage as less than or equal to 3.\n5. At initial treatment, imaging diagnoses no enlarged lymph nodes at the root of the inferior mesenteric artery.\n6. At initial treatment, imaging diagnoses the number of mesenteric metastatic lymph nodes as less than or equal to three.\n7. Strong willingness for surgery and signed informed consent.\n\nExclusion Criteria:\n\n1. Previous history of malignant colorectal tumors.\n2. Colonic biopsy pathology reveals mucinous adenocarcinoma or signet ring cell carcinoma.\n3. Imaging diagnosis of distant metastasis.\n4. Patients who have undergone multiple abdominal-pelvic surgeries or have extensive abdominal adhesions.\n5. Patients with complications such as intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery.\n6. Extensive lesions not amenable to R0 resection.\n7. Diagnosed with other malignancies within the past five years.\n8. ASA (American Society of Anesthesiologists) classification ≥ IV and\u002For ECOG (Eastern Cooperative Oncology Group) performance status score ≥ 2.\n9. Patients with severe liver, kidney, cardiac, pulmonary, coagulation dysfunctions, or serious underlying diseases that cannot tolerate surgery.\n10. History of severe mental illness.\n11. Pregnant or breastfeeding women.",{"count":120,"type":21},1384,[122],"NA","The goal of this clinical trial is to learn about whether it is safe to omit dissection of the No.253 lymph nodes in mid and low rectal cancer surgery. The main question it aims to answer is that if it is possible to achieve the same long-term survival with and without the dissection of the No.253 lymph node in mid and low rectal cancer surgery. Participants will underwent laparoscopic rectal radical resection with or without the dissection of the No.253 lymph node.",[125],"Rectal Cancer",[127,128,129],"Rectal cancer","Lymph node dissection","No.253 lymph node","2026-07-30",{"date":132,"type":34},"2026-07-31",{"date":134,"type":34},"2023-12-01",{"date":136,"type":21},"2029-12-01",{"name":40,"class":41},8,{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":147,"conditions":148,"keywords":151,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":42},"100650270","an-mri-based-study-of-intelligent-pathological-subtyping-and-grading-of-renal-tumors-100650270","NCT07743749","An MRI-Based Study of Intelligent Pathological Subtyping and Grading of Renal Tumors","Inclusion Criteria:\n\n* Patients aged 18 years or older.\n* Patients diagnosed with a renal tumor.\n* Availability of preoperative renal magnetic resonance imaging examinations.\n* Availability of a corresponding pathological diagnosis, including pathological subtype and, where applicable, histological grade.\n* Magnetic resonance images that can be successfully retrieved and are of - - sufficient quality for image analysis.\n\nExclusion Criteria:\n\n* Absence of renal magnetic resonance imaging data.\n* Absence of a corresponding pathological diagnosis or insufficient pathological subtype or grading information.\n* Magnetic resonance images that cannot be retrieved, opened, or read.\n* Poor image quality that precludes reliable image annotation or artificial intelligence analysis.",{"count":146,"type":21},900,"This retrospective + prospective, non-interventional study aims to develop and evaluate artificial intelligence methods for the detection, pathological subtyping, and histological grading of renal tumors using magnetic resonance imaging (MRI). Approximately 900 adult patients with available preoperative renal MRI examinations and postoperative pathological results will be included. The pathological findings will be used as the reference standard for model development and evaluation. In addition to MRI data, selected demographic, clinical, and laboratory information may be incorporated to improve model performance. The study will not change participants' diagnosis, treatment, or follow-up, and no additional examinations or interventions will be required. All study data will be de-identified before analysis. The ultimate goal is to develop an MRI-based intelligent diagnostic approach that may assist clinicians in the preoperative assessment and individualized management of patients with renal tumors.",[149,150],"Renal Tumor","Kidney Neoplasm",[152,153,154,149,155,156,157,158,159,160],"Magnetic Resonance Imaging","Artificial Intelligence","Deep Learning","Pathological Subtyping","Histological Grading","Multimodal Learning","Computer-Aided Diagnosis","Tumor Segmentation","Rare Renal Tumor Subtypes","2026-07-29",{"date":163,"type":34},"2026-08-04",{"date":165,"type":34},"2021-01-01",{"date":167,"type":21},"2026-12-31",{"name":40,"class":41},{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":42},"100548199","fruquintinib-and-albumin-paclitaxel-combined-with-or-without-pd-1-antibody-in-2nd-line-treatment-of-ggej-adenocarcinoma-100548199","NCT06417892","Fruquintinib and Albumin-paclitaxel Combined With or Without PD-1 Antibody in 2nd-line Treatment of G\u002FGEJ Adenocarcinoma","A Randomized Controlled Study of 2nd-line Treatment of Advanced G\u002FGEJ Adenocarcinoma With Fruquintinib and Albumin-paclitaxel in Combination With or Without PD-1 Antibody in Patients Who Have Failed Treatment With PD-1 Antibody","Inclusion Criteria:\n\n1. Have fully understood the study and voluntarily signed the informed consent;\n2. Age ≥18 years old;\n3. Pathologically confirmed advanced gastric\u002Fgastroesophageal junction adenocarcinoma with at least one systemic treatment;\n4. Frontline experienced exposure to immune drugs (including exposure to PD-1 drugs in the neoadjuvant, adjuvant, and systemic treatment stages; For patients with metastasis and recurrence within 6 months after the end of adjuvant\u002Fneoadjuvant system treatment, the above-mentioned treatment is first-line treatment);\n5. ECOG's physical condition was 0-1, and did not deteriorate within 7 days;\n6. BMI≥18;\n7. Expected survival ≥3 months;\n8. The functions of vital organs meet the following requirements (the use of any blood components and cell growth factors is not allowed within the first 14 days of enrollment) a) Absolute neutrophil count ≥1.5×109\u002FL, white blood cell ≥4.0×109\u002FL; b) Platelet ≥100×109\u002FL; c) Hemoglobin ≥90g\u002FL; d) Total bilirubin TBIL≤1.5 times ULN; e)ALT and AST≤2.5 times ULN (up to 5 times in patients with liver metastasis); f) Urea\u002Furea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN (and creatinine clearance (CCr) ≥ 50mL\u002Fmin); g) Left ventricular ejection fraction (LVEF) ≥50%; h)Fridericia's corrected QT interval (QTcF) \\\u003C470 ms. i) INR≤1.5 x ULN, APTT≤1.5 x ULN.\n9. Women of childbearing age need to take effective contraceptive measures;\n10. Good compliance, cooperate with follow-up;\n\nExclusion Criteria:\n\n1. Failure to comply with the study protocol or study procedure;\n2. Previous treatment with VEGFR inhibitors;\n3. Previously received paclitaxel therapy (except for those who received paclitaxel therapy in neoadjuvant or adjuvant therapy, and the treatment ended more than 6 months after the progression of the disease);\n4. Known HER-2 positive patients;\n5. Receive live vaccine within 4 weeks prior to enrollment or possibly during the study period;\n6. Had other malignancies within 5 years prior to enrollment, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;\n7. Had active autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment;\n8. Previously received allogeneic bone marrow transplantation or organ transplantation;\n9. Subjects who are allergic to the investigational drug or any of its adjuncts;\n10. Electrolyte abnormalities identified by the investigator as clinically significant;\n11. Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥90 mmHg;\n12. Had any disease or condition affecting drug absorption before enrollment, or the patient could not take the drug orally;\n13. Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unresectable tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by researchers before enrollment;\n14. Patients with significant evidence or history of bleeding tendency (hemorrhage \\>30 mL within 3 months, accompanied by hematemesis, stool, and blood in the stool), hemoptysis (\\>5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke events and\u002For transient ischemic attacks) within 12 months prior to enlistment;\n15. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe\u002Funstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; Congestive heart failure New York Heart Association (NYHA) Grade \\>2; Ventricular arrhythmias requiring medical treatment; LVEF (left ventricular ejection fraction) \\\u003C50%;\n16. Active or uncontrolled severe infection (≥CTCAE v5.0 grade 2 infection);\n17. Known human immunodeficiency virus (HIV) infection. A known history of clinically significant liver disease, including viral hepatitis \\[active HBV infection, i.e., positive HBV DNA (\\>1×104 copies \u002FmL or \\>2000 IU\u002Fml) must be excluded for a known hepatitis B virus (HBV) carrier; Known hepatitis C virus infection (HCV) and HCV RNA positive (\\>1×103 copies \u002FmL);\n18. Unmitigated toxicity higher than CTCAE v5.0 grade 1 due to any previous anticancer therapy, excluding alopecia, lymphocytopenia, and oxaliplatin grade ≤2 neurotoxicity;\n19. Women who are pregnant (positive pregnancy test before medication) or breastfeeding;\n20. Received blood transfusion therapy, blood products and hematopoietic factors, such as albumin and granulocyte colony-stimulating factor (G-CSF), within 28 days before enrollment;\n21. Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, which, in the investigator's judgment, reasonably suspects that the patient has a medical condition or condition that is not suitable for the use of the investigational drug (such as having seizures and requiring treatment), or which would affect the interpretation of the study results or place the patient at high risk;\n22. Urine routine indicated urinary protein ≥2+, and 24-hour urinary protein volume \\>1.0g;\n23. The patients considered by the investigators to be unsuitable for inclusion in this study.",{"count":177,"type":21},60,"To explore the efficacy and safety of fruquintinib and albumin-paclitaxel combined with or without PD-1 antibody in the second-line treatment of advanced gastric\u002Fgastroesophageal junction adenocarcinoma that failed to be treated by anti-PD-1 \u002FPD-L1 regimen",[180],"Gastric Cancer","2026-07-24",{"date":183,"type":34},"2026-07-28",{"date":185,"type":34},"2024-04-15",{"date":187,"type":21},"2027-12-30",{"name":40,"class":41},{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":97,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":4},"100648970","phase-2-multimodal-ablation-combined-with-perioperative-tislelizumab-and-chemotherapy-for-resectable-ii-iiib-nsclc-100648970","NCT07729670","Multimodal Ablation Combined With Perioperative Tislelizumab and Chemotherapy for Resectable II-IIIB NSCLC","Inclusion Criteria:\n\n* Age \\>= 18 years, either gender;\n* Pathologically confirmed stage II-IIIB (N2) squamous or non-squamous non-small cell lung cancer (NSCLC) according to the 9th edition of the AJCC\u002FUICC NSCLC staging system;\n* Presence of lesions suitable for ablation therapy confirmed by imaging evaluation;\n* Evaluated as resectable with R0 resection before enrollment, and consent to undergo radical surgical resection;\n* ECOG performance status score of 0-1;\n* Eligible for platinum-based doublet chemotherapy;\n* Adequate cardiopulmonary function to meet the requirements of curative surgical resection;\n* Sufficient organ function confirmed by laboratory tests within 28 days before enrollment:\n\n  * Blood routine: WBC \\>= 3.0×10\\^9\u002FL; ANC \\>= 1.5×10\\^9\u002FL; PLT \\>= 100×10\\^9\u002FL; HGB \\>= 90 g\u002FL.\n  * Liver function: AST \\\u003C= 5.0×ULN; ALT \\\u003C= 5.0×ULN; TBIL \\\u003C= 1.5×ULN;\n  * Renal function: Cr \\\u003C= 1.5×ULN;\n  * For patients receiving cisplatin: creatinine clearance \\>= 60 mL\u002Fmin.\n  * For patients receiving carboplatin: creatinine clearance \\>= 45 mL\u002Fmin.\n  * Coagulation function: INR \\\u003C= 1.5×ULN (\\\u003C=3×ULN for patients on anticoagulants; anticoagulants must be discontinued for one week before ablation); APTT \\\u003C= 1.5×ULN;\n* Fully understand the study and voluntarily sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n* Tumor is adjacent to the hilum, invades major blood vessels, or has contraindications for surgery;\n* History of interstitial lung disease, non-infectious pneumonia, or uncontrolled pulmonary diseases including pulmonary fibrosis and acute lung disease;\n* Previous allogeneic stem cell transplantation or organ transplantation;\n* Previous radiotherapy or chemotherapy;\n* Previous local treatment (e.g., radioactive seed implantation, ablation) for the target ablation lesion;\n* Previous treatment with immune checkpoint inhibitors, including but not limited to anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies;\n* Complicated with severe cardiac, pulmonary, hepatic, renal insufficiency, or coagulation disorders;\n* Clinically significant cardio-cerebrovascular diseases, including but not limited to acute myocardial infarction within 6 months before enrollment, heart failure of NYHA class III or IV, ventricular arrhythmia ≥ grade 2, any history of cerebrovascular accident;\n* Underwent any major surgical procedure requiring general anesthesia within 28 days before enrollment;\n* Previous severe immune system diseases or active infection;\n* Pregnant or lactating female;\n* Complicated with other malignancies (un cured within 5 years);\n* Confirmed positive EGFR or ALK driver genes by genetic testing;\n* Any condition requiring systemic therapy with corticosteroids (\\>10 mg prednisone per day or equivalent) or other immunosuppressive drugs before enrollment;\n* Severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis;\n* Known history of HIV infection;\n* Untreated chronic hepatitis B patients, chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU\u002FmL, or active hepatitis C virus (HCV) patients; (Note: Inactive hepatitis B surface antigen carriers, treated and stable hepatitis B patients (HBV DNA \\\u003C 500 IU\u002FmL), and cured hepatitis C patients are eligible.);\n* Received live vaccine within 28 days before enrollment;\n* Simultaneously participating in another therapeutic clinical study;\n* Other conditions considered unsuitable for participation in this study by the investigator.",{"count":196,"type":21},42,[99],"This is a prospective, open-label, single-center, single-arm phase II clinical trial evaluating the efficacy and safety of multimodal ablation in combination with perioperative tislelizumab and chemotherapy in patients with pathologically confirmed resectable stage II-IIIB (N2) non-small cell lung cancer (NSCLC).",[200],"NSCLC","2026-07-23",{"date":203,"type":34},"2026-07-27",{"date":205,"type":21},"2026-06",{"date":207,"type":21},"2031-06",{"name":40,"class":41},{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":18,"enrollmentInfo":216,"targetDuration":4,"studyType":97,"phases":218,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":42},"100648795","phase-2-fruquintinib-plus-anti-egfr-antibody-for-third-line-treatment-of-ras-wild-type-mcrc-100648795","NCT07724223","Fruquintinib Plus Anti-EGFR Antibody for Third-Line Treatment of RAS Wild-Type mCRC","A Phase II Study of Fruquintinib Combined With Anti-EGFR Monoclonal Antibody in Third-Line Treatment of RAS Wild-Type Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Age 18-75 years, inclusive.\n2. Fully informed about the study and willing to sign written informed consent.\n3. Histologically confirmed metastatic or advanced colorectal adenocarcinoma.\n4. Tumor confirmed as NRAS, KRAS, and BRAF wild-type.\n5. At least one measurable lesion according to RECIST 1.1 criteria.\n6. ECOG performance status of 0-1.\n7. Estimated life expectancy ≥ 12 weeks.\n8. Prior treatment with oxaliplatin- and irinotecan-based therapy, or failure of at least two prior standard regimens.\n9. Prior treatments must have included fluoropyrimidine, oxaliplatin, and irinotecan (with or without bevacizumab or cetuximab).\n10. Treatment failure defined as disease progression during therapy or within 3 months after last treatment, or intolerance to toxicity.\n11. Recurrence within 6 months after adjuvant\u002Fneoadjuvant therapy is considered as first-line failure.\n12. Adequate organ function within 7 days prior to enrollment:\n\n    * ANC ≥ 1.5 × 10⁹\u002FL\n    * Platelets ≥ 80 × 10⁹\u002FL\n    * Hemoglobin ≥ 8 g\u002FdL\n    * Total bilirubin ≤ 1.5 × ULN\n    * AST\u002FALT ≤ 2.5 × ULN (≤ 5 × ULN in liver metastasis)\n    * Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL\u002Fmin\n    * INR ≤ 1.5 or APTT ≤ 1.5 × ULN\n13. No receipt of blood products or growth factors within 14 days prior to enrollment.\n14. Able and willing to comply with study procedures and follow-up.\n\nExclusion Criteria:\n\n1. Unable or unwilling to comply with the study protocol.\n2. Prior treatment with VEGFR tyrosine kinase inhibitors (e.g., regorafenib).\n3. Participation in another clinical trial within 4 weeks.\n4. Systemic anticancer therapy within 4 weeks before enrollment.\n5. Uncontrolled hypertension (SBP \\> 140 mmHg or DBP \\> 90 mmHg).\n6. Any condition that affects drug absorption or inability to take oral medication.\n7. Active gastric or duodenal ulcer, ulcerative colitis, or tumor-related active bleeding.\n8. Positive fecal occult blood (≥ ++) without endoscopic exclusion of bleeding.\n9. Arterial or deep venous thrombosis within 6 months.\n10. Significant bleeding within 2 months (melena, hematemesis, hemoptysis).\n11. Stroke or transient ischemic attack within 12 months.\n12. Significant cardiovascular disease:\n\n    * Acute myocardial infarction within 6 months\n    * Severe or unstable angina\n    * Heart failure NYHA class \\> II\n    * Clinically significant arrhythmia requiring treatment\n    * LVEF \\\u003C 50%\n13. History of other malignancies within 5 years (except adequately treated in-situ cancers or early non-invasive cancers).\n14. Uncontrolled active infection, including HBV or HCV (HBV DNA ≥ 1×10⁴ copies\u002FmL or \\>2000 IU\u002FmL).\n15. Pregnant or breastfeeding women.\n16. Urine protein ≥ 2+ or 24-hour urine protein \\> 1.0 g.\n17. HIV-positive individuals.\n18. Any condition that, in the investigator's judgment, makes the patient unsuitable for the study.",{"count":217,"type":21},46,[99],"This study aims to evaluate the effectiveness and safety of combining fruquintinib (an oral anti-angiogenesis drug) with cetuximab-beta (an anti-EGFR antibody) in patients with RAS wild-type metastatic colorectal cancer who have already failed at least two lines of standard treatments.\n\nStandard therapies for metastatic colorectal cancer often include fluorouracil, oxaliplatin, and irinotecan. However, many patients eventually experience disease progression, and treatment options become limited. Fruquintinib and cetuximab-beta work through different mechanisms: fruquintinib blocks tumor blood vessel growth, while cetuximab-beta blocks EGFR-related cancer cell growth signals. Using these two drugs together may provide additional benefit for patients whose cancer no longer responds to other treatments.\n\nThis study will enroll 46 patients who meet the eligibility criteria. All participants will take fruquintinib by mouth once daily (3 weeks on and 1 week off) and receive cetuximab-beta by intravenous infusion every 2 weeks. Treatment will continue until the cancer progresses or side effects become intolerable.\n\nDoctors will monitor tumor changes every 8 weeks using CT or MRI scans and will also collect blood samples over time to measure circulating tumor DNA (ctDNA), which may help track how the cancer responds to treatment. Safety will be assessed through physical exams, lab tests, and monitoring of side effects.\n\nThe main goal of the study is to determine the objective response rate (ORR)-how many patients experience measurable tumor shrinkage. Secondary goals include progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety outcomes.",[221],"Metastatic Colorectal Cancer (CRC)",[223,224,225,226,227],"Metastatic Colorectal Cancer","RAS Wild-Type","Fruquintinib","Cetuximab-beta","Targeted Therapy",{"date":181,"type":34},{"date":230,"type":34},"2026-01-16",{"date":232,"type":21},"2029-01-31",{"name":40,"class":41},{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":18,"enrollmentInfo":240,"targetDuration":4,"studyType":97,"phases":242,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":42},"100519047","phase-1-an-open-single-center-clinical-study-of-surufatinib-combined-with-temozolomide-and-s-1-in-the-first-line-treatment-of-advanced-neuroendocrine-tumors-100519047","NCT06038461","An Open, Single-center Clinical Study of Surufatinib Combined With Temozolomide and S-1 in the First-line Treatment of Advanced Neuroendocrine Tumors","Inclusion Criteria:\n\n* Aged 18-75years (inclusive);\n* Histopathologically confirmed diagnosis of advanced MGMT0\u002F1+ (G1, G2 or G3) neuroendocrine tumor (locally advanced, unresectable or distant metastasis);\n* Previously untreated with systemic therapy;\n* Have at least one measurable lesion according to RECIST v1.1;\n* ECOG performance status: 0-2(determined by investigator);\n* Expected survival time \\> 3 months;\n* Adequate hepatic, renal, heart, and hematologic functions;\n* Urine protein \\\u003C ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g;\n* Before the first dose, serum HCG examination of potential childbearing-women must be negative; Men\u002FWomen of childbearing potential must agree to use a highly effective contraceptive method (such as double barrier contraceptive method, condom, oral or injectable contraceptives and intrauterine device) throughout treatment and for at least 90 days after study completion.\n\nExclusion Criteria:\n\n* Neuroendocrine cancer, adenocarcinoid, goblet cell carcinoid,\n* Functional NETs which need to control symptoms by long-acting somatostatin analogues;\n* Received a major surgery which requires at least 3 weeks after recovery time, to undergo surgery on treatment of this research within 4 weeks prior to treatment;\n* Have uncontrolled hypertension, defined as systolic blood pressure \\>140 mmHg or diastolic blood pressure \\>90 mm Hg, while under anti-hypertension treatment;\n* Patients with active ulcer, intestinal perforation and intestinal obstruction;\n* With active bleeding or bleeding tendency;\n* Severe history of cardiovascular and cerebrovascular diseases;\n* Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.",{"count":241,"type":21},40,[243,99],"PHASE1","This is a prospective, open, single-center study evaluating the efficacy and safety of surufatinib Combined With Temozolomide and S-1 as the first-line treatment of advanced neuroendocrine tumors",[246],"Neuroendocrine Tumors",[248,249,250],"Surufatinib","Temozolomide and S-1","First-line treatment",{"date":181,"type":34},{"date":253,"type":34},"2023-09-15",{"date":255,"type":21},"2028-09-15",{"name":40,"class":41},{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":18,"enrollmentInfo":264,"targetDuration":4,"studyType":97,"phases":265,"briefSummary":266,"conditions":267,"keywords":270,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":288},"100646545","phase-2-chemoradiotherapy-and-shr-1701-in-patients-with-unresectable-gastric-cancer-100646545","NCT07689851","Chemoradiotherapy and SHR-1701 in Patients With Unresectable Gastric Cancer","Safety and Efficacy of Radiotherapy Combined With Chemotherapy and SHR-1701, a PD-L1(Programmed Death-Ligand 1)\u002FTGF-β(Transforming Growth Factor-beta) Bispecific Antibody, in the Treatment of Unresectable Locally Advanced or Metastatic Gastric Cancer","Inclusion Criteria:\n\n1. Male or female participants aged 18 to 75 years.\n2. Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.\n3. Unresectable locally advanced or metastatic gastric cancer, with primary and metastatic lesions amenable to radiotherapy (excluding patients with brain metastases or extensive metastatic disease).\n4. HER2-negative disease.\n5. ECOG performance status of 0-1.\n6. At least one measurable lesion according to RECIST version 1.1.\n7. Adequate organ function, including:\n\n   * Hemoglobin ≥90 g\u002FL;\n   * White blood cell count ≥3.5 × 10⁹\u002FL;\n   * Absolute neutrophil count ≥1.5 × 10⁹\u002FL;\n   * Platelet count ≥100 × 10⁹\u002FL;\n   * Serum creatinine ≤1.0 × upper limit of normal (ULN);\n   * Blood urea nitrogen (BUN) ≤1.0 × ULN;\n   * Alanine aminotransferase (ALT) ≤1.5 × ULN;\n   * Aspartate aminotransferase (AST) ≤1.5 × ULN;\n   * Alkaline phosphatase (ALP) ≤1.5 × ULN;\n   * Total bilirubin (TBIL) ≤1.5 × ULN;\n   * Negative urine protein;\n   * Normal coagulation function.\n8. No contraindications to immunotherapy.\n9. No history of hypersensitivity to fluoropyrimidines or platinum-based agents.\n10. No prior surgery, chemotherapy, immunotherapy, or other antitumor therapy for gastric or gastroesophageal junction cancer since diagnosis.\n11. No previous radiotherapy to the intended irradiation sites.\n12. Ability to understand and willingness to sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Brain metastases or extensive metastatic disease.\n2. Prior treatment with PD-1, PD-L1, TGF-β, CTLA-4 inhibitors, or other investigational immunotherapies.\n3. Severe autoimmune diseases, including but not limited to active inflammatory bowel disease (Crohn's disease or ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, or autoimmune vasculitis (e.g., Wegener's granulomatosis).\n4. Symptomatic interstitial lung disease or active infectious\u002Fnon-infectious pneumonitis.\n5. Conditions associated with an increased risk of gastrointestinal perforation, including active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, abdominal carcinomatosis, or other known risk factors.\n6. History of another malignancy, except adequately treated early-stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or carcinoma in situ of the cervix.\n7. Active infection, heart failure, myocardial infarction within 6 months, unstable angina, or unstable cardiac arrhythmia.\n8. Any physical examination findings, laboratory abnormalities, or uncontrolled medical conditions that, in the investigator's judgment, may interfere with study outcomes or increase the risk of treatment-related complications.\n9. Pregnant or breastfeeding women.\n10. Congenital or acquired immunodeficiency, including HIV infection, or a history of organ transplantation or allogeneic hematopoietic stem cell transplantation.\n11. Active hepatitis B infection (HBV DNA ≥2,000 IU\u002FmL), active hepatitis C infection, or active tuberculosis.\n12. Receipt of any live or other prohibited vaccines within 4 weeks before study treatment. Seasonal inactivated influenza vaccines are permitted, whereas intranasal live attenuated influenza vaccines are not permitted.\n13. Concurrent treatment with other immunosuppressive agents, chemotherapy, investigational drugs, or long-term systemic corticosteroids.\n14. Psychiatric disorders, substance abuse, or social conditions that may compromise treatment compliance, as determined by the investigator.\n15. Known hypersensitivity or contraindication to any study treatment.",{"count":177,"type":21},[99],"Gastric Cancer is one of the leading causes of cancer-related death worldwide, and patients with unresectable locally advanced or metastatic disease have a poor prognosis. This study aims to evaluate the safety and efficacy of radiotherapy combined with CAPOX and SHR-1701, a PD-L1\u002FTGF-β bispecific antibody, in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. By improving local tumor control and enhancing systemic antitumor activity, this study seeks to increase the opportunity for curative-intent resection and improve survival outcomes in patients with advance gastric cancer.",[268,269],"Gastric Cancer (GC)","Gastroesophageal Junction Adenocarcinoma",[271,272,273,274,275,276,277,278,279],"Radiotherapy","CAPOX","SHR-1701","Immunotherapy","Chemotherapy","Unresectable gastric cancer","Metastatic gastric cancer","Locally advanced gastric cancer","PD-L1\u002FTGF-β bispecific antibody","2026-07-05",{"date":282,"type":34},"2026-07-08",{"date":284,"type":21},"2026-07-01",{"date":286,"type":21},"2029-07-30",{"name":40,"class":41},3,{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":18,"enrollmentInfo":296,"targetDuration":4,"studyType":97,"phases":298,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":316},"100646324","phase-3-sintilimab-versus-mitomycin-in-combination-with-capecitabine-and-imrt-for-limited-stage-anal-squamous-cell-carcinoma-100646324","NCT07692152","Sintilimab Versus Mitomycin in Combination With Capecitabine and IMRT for Limited-stage Anal Squamous Cell Carcinoma","A Multicenter, Phase III, Randomized Controlled Clinical Trial of Sintilimab Versus Mitomycin in Combination With Capecitabine and Intensity-Modulated Radiotherapy in the Treatment of Limited-stage Anal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Histopathologically confirmed primary anal squamous cell carcinoma, including a subset of rectal squamous cell carcinomas. Definition for inclusion of rectal squamous cell carcinomas: According to Williams' criteria (1979) and WHO classification (2019), rectal squamous cell carcinomas included in this study must meet all of the following criteria: (1) Histopathologically confirmed as pure squamous cell carcinoma, excluding adenosquamous carcinoma; (2) Digital examination\u002Fendoscopy\u002FMRI confirmation that the tumor mass is entirely located in the rectum (above the dentate line), with no evidence of primary origin in the anal canal or upward spread. If the inferior border of the tumor is within 5-6 cm from the anal verge, and the patient is scheduled to undergo radical radiotherapy and chemotherapy, the rectal squamous cell carcinoma can be diagnosed and screened for inclusion (When the primary epicenter cannot be determined, regardless of which side the tumor mass is biased towards, the diagnosis shall be considered for screening and inclusion as anal squamous cell carcinoma); (3) Female patients must be excluded for rectal metastasis from cervical squamous cell carcinoma (baseline gynecological examination is recommended).\n2. Staged as cT2-T4N0M0 or cTanyN+M0 by imaging (AJCC 9th).\n3. No prior tumor resection surgery (other than biopsy) or chemotherapy or other anti-tumor therapy.\n4. Aged 18-75 years old.\n5. ECOG performance status of 0-1.\n6. Adequate organ function reserve: white blood cell (WBC) count ≥3 × 10\\^9\u002FL, absolute neutrophil count (ANC) ≥1.5 × 10\\^9\u002FL, hemoglobin (Hb) level \\>90 g\u002FL, platelet (PLT) count \\>100 × 10\\^9\u002FL; serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels \\\u003C2.5 times the upper limit of normal (ULN); serum bilirubin level ≤1.5 × ULN; serum creatinine (Cr) level \\\u003C1.5 × ULN; international normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤1.5 × ULN.\n7. No known history of allergy to the study drugs.\n8. No prior radiotherapy to the planned radiation site.\n9. Non-pregnant and non-lactating women.\n10. For HIV-positive patients: at the initiation of the study, a stable combined antiretroviral therapy (CART) regimen must be used, with an HIV viral load of \\\u003C50 copies\u002FmL or below the limit of detection, and a CD4+ T-cell count \\>300\u002FµL. Patients will be closely monitored during the study, and CART management will follow antiviral treatment guideline recommendations.\n11. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Perianal squamous cell carcinoma originating from the perianal skin without invasion of the anal canal or anal sphincter. (For tumors with an ill-defined primary site, if clinical judgment indicates the main tumor mass involves the anal canal or is associated with anal sphincter invasion requiring sphincter-preserving chemoradiotherapy, the patient is eligible for inclusion.)\n2. Perianal Paget's disease.\n3. Pregnant or lactating women.\n4. Severe comorbidities or any medical\u002Fpsychiatric condition deemed unsuitable for participation in this study.\n5. Patients with prior antitumor immunotherapy (e.g., anti-CTLA-4, anti-PD-1, or anti-PD-L1 monoclonal antibodies, etc.), with the exception of anti-HPV vaccination.\n6. History of other malignancies diagnosed within the past 3 years, except for curatively treated basal cell carcinoma of the skin and\u002For completely resected carcinoma in situ of the cervix, breast, or thyroid.\n7. Requires chronic use of immunosuppressive medications.\n8. Patients with severe autoimmune diseases, including but not limited to: symptomatic interstitial lung disease, or active infectious\u002Fnon-infectious pneumonia; active inflammatory bowel disease (including Crohn's disease, ulcerative colitis); rheumatoid arthritis; scleroderma; systemic lupus erythematosus; autoimmune vasculitis; myasthenia gravis; myositis; autoimmune hepatitis; antiphospholipid syndrome; Wegener's granulomatosis; Sjögren's syndrome; Guillain-Barré syndrome; or multiple sclerosis, etc.\n9. History of organ transplantation or allogeneic stem cell transplantation.\n10. Patients with laboratory test values not meeting the relevant criteria within 7 days prior to enrollment.\n11. Patients with significantly impaired cardiac, hepatic, pulmonary, renal, or bone marrow function.\n12. Patients with severe, uncontrolled medical conditions or infections. Examples include: severe myocardial infarction, heart failure, unstable angina, or unstable arrhythmia within the past 6 months; respiratory failure and chronic obstructive pulmonary disease; active hepatitis B virus (HBV) infection (HBV-DNA ≥2000 U\u002FmL); hepatitis C virus (HCV) infection; active tuberculosis infection, etc.\n13. Concurrent use of other investigational drugs or participation in other clinical trials.\n14. Patients who refuse or are unable to sign the informed consent form for participation in the trial.\n15. Patients with known allergies or contraindications to the investigational anti-tumor drug or any of its excipients.\n16. Patients deemed by the investigator to be unsuitable for participation in the study and unlikely to comply with the study procedures, restrictions, and requirements.",{"count":297,"type":21},350,[299],"PHASE3","This is a prospective, multicenter, open-label, phase III randomized controlled clinical trial designed to evaluate the efficacy and safety of replacing the traditional chemotherapeutic drug mitomycin with the PD-1 inhibitor sintilimab in definitive chemoradiotherapy for limited-stage anal squamous cell carcinoma. The study plans to enroll 350 previously untreated patients with limited-stage anal squamous cell carcinoma and randomize them in a 1:1 ratio into two groups: the control group will receive the current standard treatment, namely intensity-modulated radiotherapy (IMRT) concurrent with capecitabine and mitomycin; the experimental group will receive an innovative \"immunotherapy replacement\" regimen, namely IMRT of the same technique concurrent with capecitabine and sintilimab. The study adopts a dual primary endpoint design, aiming to verify that the experimental group is non-inferior to the control group in the clinical complete response rate at 6 months after radiotherapy, and is significantly superior to the control group in the incidence of grade 3 or higher treatment-related acute toxicities.",[302],"Anal Squamous Cell Carcinoma, Limited-stage",[304,305,306,307],"anal squamous cell carcinoma","intensity-modulated radiotherapy","immune checkpoint inhibitors","immunotherapy","2026-07-02",{"date":310,"type":34},"2026-07-09",{"date":312,"type":34},"2026-03-17",{"date":314,"type":21},"2029-03",{"name":40,"class":41},2,{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":323,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":18,"enrollmentInfo":325,"targetDuration":4,"studyType":97,"phases":327,"briefSummary":328,"conditions":329,"keywords":331,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":42},"100621133","phase-1-safety-tolerability-and-preliminary-efficacy-of-neuk203-13-in-refractory-neuroendocrine-tumor-patients-100621133","NCT07366658","Safety, Tolerability and Preliminary Efficacy of NEUK203-13 in Refractory Neuroendocrine Tumor Patients","A Study to Explore the Safety, Tolerability, and Preliminary Efficacy of NEUK203-13 Injection in Patients With Neuroendocrine Tumors Who Have Failed Systemic Therapy","NEUK203-13","Inclusion Criteria:\n\n* 1\\. Understand and voluntarily sign the Informed Consent Form (ICF);\n* 2\\. Aged ≥ 18 years and \\\u003C 75 years at the time of signing the ICF, regardless of gender;\n* 3\\. Pathologically confirmed neuroendocrine tumors, including small cell lung cancer (SCLC), etc.;\n* 4\\. Previous failure or intolerance to systemic therapy, or recurrence after remission: among them, patients with small cell lung cancer must have received at least platinum-based chemotherapy with or without PD-1\u002FPD-L1 inhibitors in previous treatments, with imaging evidence of disease progression after treatment;\n* 5\\. Must provide tissue samples for biomarker analysis, preferably newly obtained tissues. For patients unable to provide newly obtained tissues, 4 unstained sections of archived formalin-fixed, paraffin-embedded (FFPE) tissues can be provided (at least 1 patient with high DLL3 expression shall be enrolled in each dose group: high expression is defined as positive staining in ≥ 50% of tumor cells; preference is given to enrolling DLL3-positive patients);\n* 6\\. Have at least one measurable lesion as the target lesion (per RECIST v1.1 criteria);\n* 7\\. Expected survival ≥ 3 months;\n* 8\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n* 9\\. Have adequate bone marrow reserve and organ function within 7 days before the first administration of NEUK203-13 Injection:\n* 10\\. Sufficient bone marrow function (no supportive therapy within 14 days before the first administration): hemoglobin (Hb) ≥ 90 g\u002FL, platelets (PLT) ≥ 75 × 10⁹\u002FL, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL;\n* 11\\. Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN), total bilirubin (TBIL) \\\u003C 1.5 × ULN;\n* 12\\. Renal function: serum creatinine (Scr) ≤ 1.5 × ULN and creatinine clearance rate (Ccr) ≥ 60 mL\u002Fmin (calculated according to the Cockcroft-Gault formula); Coagulation function: prothrombin time (PT) ≤ 1.5 × ULN, international normalized ratio (INR) ≤ 2.0;\n* 13\\. Female patients of childbearing potential or male patients whose partners are of childbearing potential agree to use highly effective contraceptive measures from any dose administration in the study until 6 months after the last dose of the study.\n\nExclusion Criteria:\n\n* 1\\. Mixed carcinoma with non-neuroendocrine tumor components;\n* 2\\. Active brain metastases (patients with stable disease for 3 months after treatment without the need for continued glucocorticoid therapy are eligible for enrollment); known leptomeningeal metastases; isolated central nervous system (CNS) disease progression without evidence of progression outside the CNS;\n* 3\\. A history of hypersensitivity to interleukin-2 (IL-2), fludarabine, cyclophosphamide, tocilizumab, or any component of the infusion product formulation; or patients with a history of specific allergic disorders (asthma, rubella, eczematous dermatitis);\n* 4\\. Prior receipt of any of the following treatments:\n* 5\\. Any systemic antineoplastic therapy within 4 weeks or 5 half-lives prior to the first administration of NEUK203-13 Injection, whichever is shorter;\n* 6\\. Radiotherapy not involving the thoracic cavity within 2 weeks prior to the first administration of NEUK203-13 Injection, or radiotherapy involving the thoracic cavity within 4 weeks prior to the first administration of the study drug, whichever is longer;\n* 7\\. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study;\n* 8\\. Prior vaccination with an antineoplastic vaccine, or receipt of a live vaccine within 4 weeks prior to the first administration of NEUK203-13 Injection;\n* 9\\. Major surgery or severe trauma within 4 weeks prior to the first administration of NEUK203-13 Injection;\n* 10\\. Failure of toxicities from prior antineoplastic therapy to resolve to ≤ Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) (except alopecia) or to the level specified in the inclusion\u002Fexclusion criteria, whichever is more stringent;\n* 11\\. Active autoimmune disease or a history of autoimmune disease (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); exceptions include patients with vitiligo, patients with a history of childhood asthma\u002Fallergies that have resolved completely and require no intervention in adulthood, patients with autoimmune-mediated hypothyroidism receiving a stable dose of thyroid replacement hormone, and patients with type 1 diabetes receiving a stable dose of insulin;\n* 12\\. A history of immunodeficiency, including positive HIV test results, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation;\n* 13\\. Severe infection (CTCAE \\> Grade 2) within 4 weeks prior to the first administration of NEUK203-13 Injection, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging indicating active pulmonary inflammation; or presence of signs and symptoms of infection requiring oral or intravenous antibiotic therapy within 2 weeks prior to the first administration of the study drug (except for prophylactic antibiotic use);\n* 14\\. Tuberculosis infection identified by medical history or CT examination; Active hepatitis B (HBV DNA ≥ 500 IU\u002FmL), hepatitis C (positive anti-HCV antibodies and HCV-RNA above the lower limit of detection of the assay), or positive syphilis test results (including positive RPR or TPPA);\n* 15\\. Prior diagnosis of any other malignant tumor, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or breast cancer, or adequately treated localized prostate cancer;\n* 16\\. Pregnant or lactating women;\n* 17\\. Uncontrolled concurrent diseases, including but not limited to: documented cerebrovascular events (stroke or transient ischemic attack) within 6 months prior to the first administration of the study drug, symptomatic congestive heart failure, left ventricular ejection fraction (LVEF) \\\u003C 50%, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmias, severe chronic gastrointestinal disease with diarrhea, or severe dyspnea requiring oxygen therapy;\n* 18\\. A definite history of neurological or psychiatric disorders that, in the investigator's judgment, may affect the patient's cognitive function or compliance, including unstable epilepsy, dementia, schizophrenia, etc.; or psychiatric illnesses\u002Fsocial conditions that may affect study compliance, significantly increase the risk of adverse events, or impair the patient's ability to provide written informed consent;\n* 19\\. Other factors judged by the investigator that may force the patient to terminate the study prematurely, such as severely abnormal laboratory test results, and\u002For family or social factors that may affect patient safety or the collection of trial data.",{"count":326,"type":21},9,[243],"This is a Phase I clinical trial being conducted in humans for the first time, aiming to evaluate a novel cell therapy called NEUK203-13 Injection for the treatment of patients with advanced small cell lung cancer (SCLC) who have failed systematic therapy or late stage neuroendocrine tumors(NETs). The primary goal of the study is to determine the safety and tolerability of this new therapy and to preliminarily observe its anti-tumor effects.\n\nNEUK203-13 Injection is an \"off-the-shelf\" CAR-NK cell therapy developed based on induced pluripotent stem cell (iPSC) technology, targeting the DLL3 protein highly expressed in SCLC or other neuroendocrine tumors(NETs) .\n\nPrimary Objective Primary Endpoint aims to evaluate safety and tolerability Secondary Endpoints aim to preliminarily observe efficacy and investigate the pharmacokinetics of the drug in the body.\n\nTwo pre-set dose levels are planned, with an enrollment of 7-9 patients. Treatment Regimen\n\n1. Lymphodepletion Conditioning: Chemotherapy (Cyclophosphamide + Fludarabine) before cell infusion to clear lymphocytes in the body.\n2. Cell Infusion: NEUK203-13 is administered via intravenous infusion, d1，d4 and d7 for three doses.\n3. Supportive Medication: Concurrent use of IL-2 (Interleukin-2) d1, d4, d7 and d10 to support NK cell persistence.\n\nTarget Patient Population Patients with advanced SCLC who have progressed after prior platinum-based chemotherapy or late stage neuroendocrine tumors(NETs) and have a relatively good performance status.\n\nKey Monitoring Focus Close monitoring of risks specific to cell therapy, such as Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).\n\nIn short, this study represents the first clinical exploration of NEUK203-13 Injection in patients with advanced small cell lung cancer or other neuroendocrine tumors(NETs). Its primary focus is on safety, while simultaneously gathering preliminary signals on whether the therapy can control tumors, thereby laying the foundation for subsequent clinical development.",[330,246],"SCLC, Extensive Stage",[332,333],"Car-NK cells","iPSC","2026-06-23",{"date":336,"type":34},"2026-06-25",{"date":338,"type":34},"2026-02-20",{"date":340,"type":21},"2027-01-20",{"name":40,"class":41},{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":349,"targetDuration":4,"studyType":97,"phases":351,"briefSummary":352,"conditions":353,"keywords":355,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":42},"100644748","a-phase-ii-study-of-radiation-therapy-to-treat-refractory-breast-cancer-100644748","NCT07672743","A Phase II Study of Radiation Therapy to Treat Refractory Breast Cancer","A Prospective Phase II Study of Radiation Therapy to Treat Refractory Breast Cancer","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;\n* Locally advanced or recurrent metastatic breast cancer, pathologically confirmed;\n* At least one extracranial measurable lesion suitable for radiotherapy;\n* Signature of informed consent form.\n\nExclusion Criteria:\n\n* Pregnant or lactation women;\n* Severe concomitant conditions, including persistent or active infections, symptomatic congestive heart failure, unstable angina pectoris, and serious arrhythmias et al.",{"count":350,"type":21},29,[122],"For locally advanced or recurrent metastatic breast cancer that is resistant to systemic therapy, radiotherapy (RT) may be considered as the preferred treatment option when the lesion is unresectable, or the patient is not suitable for surgery. This study aim to evelatuate the local control of radical dose RT or new RT technique (such as patially fractionated radiation therapy, SFRT) for the locally advanced or recurrent metastatic breast cancer.",[354],"Breast Cancer",[356,357,358],"breast cancer","radiotherapy","spatially fractionated radiation therapy","2026-06-22",{"date":361,"type":34},"2026-06-29",{"date":363,"type":21},"2026-06-30",{"date":365,"type":21},"2027-12-31",{"name":40,"class":41},{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":376,"conditions":377,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":42},"100644063","characterization-of-multi-omics-landscapes-and-ai-pathological-prediction-model-for-long-term-survival-in-nsclc-immunotherapy-100644063","NCT07668037","Characterization of Multi-Omics Landscapes and AI Pathological Prediction Model for Long-Term Survival in NSCLC Immunotherapy","Characterization of Multi-Omics Landscapes in Long-Term Survival Following Immunotherapy and Development of an AI Pathological Prediction Model for Long-Term Survival Based on H&E-Stained Images in Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Patients with pathologically confirmed advanced or locally advanced non-small cell lung cancer (NSCLC).\n* Patients derived from real-world data of multiple centers (including Cancer Hospital, Chinese Academy of Medical Sciences; Cancer Hospital of Shanxi, Chinese Academy of Medical Sciences \\[Shanxi Cancer Hospital\\]; and other participating centers) or from completed phase III clinical trials (e.g., Choice-01, Rationale-307, Rationale-304).\n* Patients who received first-line or later-line immune checkpoint inhibitor (ICI) monotherapy or ICI-based combination therapy.\n* Patients with complete clinical information and available follow-up data.\n\nExclusion Criteria:\n\n* Patients whose systemic therapy did not include an immunotherapy regimen.\n* Patients lost to follow-up.",{"count":375,"type":21},600,"This study is a retrospective, multicenter, observational cohort study in patients with advanced or locally advanced non-small cell lung cancer (NSCLC). The aim of this study was to establish a long-term survival (LTS) versus short-term survival (STS) real-world cohort, to systematically characterize the multi-omics landscapes, and to develop and validate an artificial intelligence (AI) pathological prediction model based on routine H\\&E-stained images for predicting immune microenvironment features and long-term survival outcomes following immunotherapy.",[378,274,379],"Non-Small Cell Carcinoma of Lung","Advanced Non-Small Cell Lung Cancer",{"date":336,"type":34},{"date":382,"type":34},"2026-05-01",{"date":384,"type":21},"2030-05-01",{"name":40,"class":41},{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":392,"enrollmentInfo":393,"targetDuration":4,"studyType":97,"phases":395,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":42},"100642039","phase-2-efficacy-and-safety-of-postoperative-concurrent-chemoradiotherapy-for-extrahepatic-cholangiocarcinoma-and-gallbladder-carcinoma-a-multicenter-prospective-phase-ii-study-100642039","NCT07636824","Efficacy and Safety of Postoperative Concurrent Chemoradiotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma: A Multicenter Prospective Phase II Study","Inclusion Criteria:\n\n* Aged 18-80 years\n* Underwent curative resection for newly diagnosed disease, with postoperative pathology confirming extrahepatic cholangiocarcinoma or gallbladder adenocarcinoma\n* Postoperative pathology with ≥1 high-risk factor for recurrence\n\n  1. Narrow resection margin (\\\u003C1 cm), including R1 resection\n  2. Positive circumferential resection margin\n  3. T stage ≥ T3-4\n  4. Positive regional lymph nodes\n* Postoperative liver function: Child-Pugh grade A5-B7\n* No recurrence or metastasis before postoperative radiotherapy\n* ECOG performance status 0-2\n* Expected survival \\>3 months\n* Routine blood tests: Neutrophils ≥1.0×10⁹\u002FL, hemoglobin ≥80 g\u002FL, platelets ≥100×10⁹\u002FL\n* Liver function: Total bilirubin \\\u003C1.5×upper limit of normal (ULN), plus one of the following:\n\n  1. ALT and AST ≤2.5×ULN\n  2. ALT ≤1.5×ULN and AST ≤6×ULN (excluding AST elevation due to myocardial infarction)\n* Renal function: Creatinine and blood urea nitrogen ≤2.5×ULN\n* Voluntary participation and signed informed consent\n\nExclusion Criteria:\n\n* History of other malignant tumors (except papillary thyroid carcinoma, basal cell carcinoma of the skin, and cervical carcinoma in situ)\n* Severe comorbidities (e.g., myocardial infarction, arrhythmia, psychiatric disorders)\n* Prior abdominal radiotherapy\n* Post-organ transplantation\n* Symptomatic moderate-severe ascites within 4 months postoperatively\n* ≥4 months since surgery","80 Years",{"count":394,"type":21},92,[99],"This is a multicenter, open-label, single-arm, prospective Phase II clinical trial. The study enrolls patients with extrahepatic cholangiocarcinoma or gallbladder carcinoma who have undergone curative resection and harbor high-risk recurrence factors, including: 1) narrow resection margin (including R1 resection); 2) positive circumferential resection margin; 3) T stage ≥ T3-4; 4）positive regional lymph nodes. All patients will receive postoperative concurrent chemoradiotherapy (CCRT) with intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT). The high-risk volumes of the primary tumor bed and metastatic lymph node beds will be irradiated to 48-60 Gy in 20-25 fractions. Retroperitoneal and intra-abdominal lymph nodes will receive 50-57.5 Gy in 20-25 fractions, and lymphatic drainage regions will be treated to 40-45 Gy in 20-25 fractions. During radiotherapy, concurrent oral capecitabine will be administered at a dose of 1,600 mg\u002Fm² on Days 1-14, every 21 days for 2 cycles. Following the completion of radiotherapy, maintenance oral capecitabine will be continued at 2,000 mg\u002Fm² on Days 1-14, every 21 days for 6 cycles. For patients intolerant to capecitabine, S-1 will be substituted: concurrent S-1 40-50 mg twice daily on Days 1-28, every 42 days for 1 cycle, followed by maintenance S-1 40-60 mg twice daily on Days 1-28, every 42 days for 3 cycles.\n\nThe primary study endpoint is the 2-year recurrence-free survival (RFS) rate. Secondary study endpoints include the 2-year overall survival (OS) rate, locoregional control rate, and incidence of grade ≥3 adverse events.\n\nA total of 92 patients are planned for enrollment in this trial.",[398],"Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma","2026-06-21",{"date":401,"type":34},"2026-06-24",{"date":403,"type":34},"2026-06-16",{"date":405,"type":21},"2029-05-30",{"name":40,"class":41},{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":414,"targetDuration":4,"studyType":97,"phases":416,"briefSummary":417,"conditions":418,"keywords":421,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":42},"100599440","phase-3-hypofractionated-vs-conventional-rt-after-prosthetic-breast-reconstruction-100599440","NCT07084519","Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction","Randomized Controlled Trial of Postmastectomy Hypofractionated Radiotherapy Versus Conventional Fractionated Radiotherapy in Breast Cancer Patients Undergoing Prosthetic Breast Reconstruction","Inclusion Criteria:\n\n* Female, aged 18-75 years\n* Karnofsky Performance Status ≥60\n* Histopathologically confirmed invasive breast adenocarcinoma\n* Total mastectomy \\[with or without nipple-areolar complex preservation\\] + axillary dissection\u002Fsentinel lymph node biopsy + implant\u002Fexpander placement R0 resection with negative margins\n* pT3 or N2-3 disease; or pT1-2N1\n* No distant metastasis\n* Completed standard neoadjuvant\u002Fadjuvant chemotherapy cycles\n* ≤8 weeks post-chemotherapy or ≤12 weeks post-surgery if no chemotherapy\n* Signed informed consent\n\nExclusion Criteria:\n\n* Prior radiotherapy to chest wall or nodal regions\n* Pregnancy or lactation\n* T4 stage disease\n* Autologous breast reconstruction of the irradiated breast\n* Pre-radiotherapy local\u002Fregional\u002Fdistant metastasis\n* Grade ≥3 implant-related adverse events irreversible before radiotherapy\n* Bilateral breast cancer requiring bilateral radiotherapy\n* Concurrent\u002Fsecondary malignancy with disease-free interval \\\u003C5 years \\[except non-melanoma skin cancer, papillary\u002Ffollicular thyroid cancer, or cervical carcinoma in situ\\]\n* Active collagen vascular disease, e.g., SLE, scleroderma\n* Uncontrolled comorbidities: acute cardiovascular disease, substance abuse, or psychiatric disorders",{"count":415,"type":21},506,[299],"This study investigates the safety and efficacy of hypofractionated radiotherapy (HFRT) versus conventional fractionated radiotherapy (CFRT) in breast cancer patients undergoing total mastectomy with prosthetic reconstruction.\n\nStudy Design Population: Patients with high-risk breast cancer after mastectomy and immediate implant reconstruction.\n\nIntervention:\n\nHFRT Arm: 43.5 Gy in 15 fractions (2.9 Gy\u002Ffraction, 3 weeks). Control Arm: CFRT (50 Gy in 25 fractions, 2 Gy\u002Ffraction, 5 weeks). Endpoints Primary: Reconstruction failure rate (e.g., implant removal, capsular contracture)",[354,419,420],"Breast Reconstruction","Radiation Oncology",[356,422,423],"prosthetic breast reconstruction","hypofractionated radiotherapy","2026-06-17",{"date":359,"type":34},{"date":427,"type":34},"2026-03-27",{"date":429,"type":21},"2030-12-31",{"name":40,"class":41},{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":97,"phases":439,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":448,"locationsCount":4},"100642582","phase-2-ovv-01-injection-combined-with-ak112-injection-for-the-treatment-of-patients-with-advanced-soft-tissue-sarcoma-sts-100642582","NCT07650838","OVV-01 Injection Combined With AK112 Injection for the Treatment of Patients With Advanced Soft Tissue Sarcoma (STS)","A Single-Arm, Open-Label, Multicenter Clinical Study Evaluating the Safety and Efficacy of OVV-01 Injection Combined With AK112 Injection in Patients With Advanced Soft Tissue Sarcoma (STS)","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form, understand this study, and agree to comply with the protocol and complete all trial procedures;\n2. Be at least 18 years of age at the time of signing the ICF, with no gender restrictions.\n3. Histologically\u002Fcytologically confirmed metastatic or recurrent unresectable soft tissue sarcoma, currently failing standard therapy (disease progression, recurrence, or intolerance to treatments such as chemotherapy, radiotherapy, or targeted therapy) or lacking standard treatment options. Participants must have progressed after receiving at least two standard therapies (including but not limited to targeted therapies). Subjects must have demonstrated failure or intolerance to anthracycline-based standard chemotherapy regimens. For specific histologic subtypes lacking standard effective chemotherapy options (e.g., alveolar soft part sarcoma), subjects may have previously received targeted therapy (e.g., anti-angiogenic agents such as anlotinib, pazopanib) with failure or intolerance.\n4. Subjects must have at least one measurable lesion as defined by RECIST 1.1 criteria, i.e., non-lymph node lesions with a longest diameter ≥10 mm and lymph node lesions with a shortest diameter ≥15 mm on CT or MRI. Injectable tumor lesions must be present, including superficial lesions and deep lesions amenable to injection under ultrasound\u002FCT\u002For endoscopic guidance.\n5. ECOG performance status of 0-2, with an estimated survival of at least 12 weeks.\n6. Sufficient organ and hematopoietic function:Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet count ≥ 75 × 10⁹\u002FL (no platelet transfusion or thrombopoietin (TPO) therapy within 2 weeks prior to first dose); Hemoglobin ≥ 90 g\u002FL (no blood transfusion within 2 weeks); Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (CCr) ≥ 50 mL\u002Fmin; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN; for patients with liver metastases, AST and ALT \\\u003C 5 × ULN; Serum total bilirubin (TBIL) ≤ 2 × ULN; International Normalized Ratio (INR) ≤ 1.5 × ULN, or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN;\n7. Women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation.\n8. Male and female subjects of childbearing potential must agree to use reliable contraception during the trial and for at least six months after the last dose.\n\nExclusion Criteria:\n\n1. Patients with known brain metastases and\u002For clinically suspected brain metastases (however, patients with asymptomatic brain metastases or those clinically stable for over 3 months following local treatment may be enrolled);\n2. Subjects who received radiotherapy to the target lesion within the past 2 months;\n3. Subjects with other active malignancies within the past 5 years. Exceptions include subjects who have achieved complete remission and require no follow-up treatment, or subjects with malignancies within the scope of the indication;\n4. Lesions intended for injection with a maximum diameter \\>100 mm;\n5. Participants who have participated in or are currently participating in other drug or medical device clinical trials within the past 4 weeks;\n6. Participants scheduled for or who have previously undergone tissue\u002Forgan transplantation;\n7. Participants with Human Immunodeficiency Virus (HIV) infection who have experienced AIDS-related opportunistic infections within the past 12 months, or who have a CD4+ T-cell (CD4+) count \\\u003C 350 cells\u002FuL; Patients with positive hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) at screening, and HBV-DNA above the lower limit of detection; patients with positive HCV antibody at screening and HCV-RNA above the lower limit of detection; subjects with positive syphilis serology;\n8. Subjects requiring antiviral therapy during the study period or within 5 half-lives of the first dose of antiviral therapy.\n9. Subjects requiring therapeutic anticoagulant therapy during the study period.\n10. Subjects with uncontrolled active infection of ≥Grade 3 severity according to CTCAE v5.0 that is clinically significant;\n11. Received antineoplastic therapy (chemotherapy, radiotherapy, biologic therapy, endocrine therapy, immunotherapy, etc.) within 4 weeks prior to first dose; received small-molecule targeted therapy or oral fluorouracil-based agents within 2 weeks prior to first dose or within 5 half-lives (whichever is longer); Received Chinese herbal medicine or proprietary Chinese medicine with antitumor indications within 2 weeks prior to first dose; received nitrosourea or mitomycin C within 6 weeks prior to first dose; palliative radiotherapy for non-target lesions is permitted (≥2 weeks prior to first dose);\n12. Uncontrolled hypertension, pulmonary hypertension, or unstable angina; myocardial infarction, coronary artery bypass grafting, or stent placement within 6 months prior to dosing; history of chronic heart failure at New York Heart Association (NYHA) functional class III-IV; Severe arrhythmias requiring treatment (excluding atrial fibrillation or paroxysmal supraventricular tachycardia deemed by the investigator as not affecting the trial), including QTcF ≥450 ms in males or ≥470 ms in females (calculated using Fridericia's formula); cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to enrollment;\n13. Active autoimmune disease or history of autoimmune disease with potential for recurrence;\n14. Requirement for systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive therapy within 14 days prior to first dose or during the study period;\n15. Tumors located in high-risk areas (including mucosal regions, proximity to airways, major vessels, or spinal cord) that may cause obstruction or compression due to tumor enlargement, erode major vessels due to necrosis, encase major vascular structures (e.g., carotid artery), tumors adjacent to critical neurovascular structures, or other tumors deemed unsuitable for intratumoral injection;\n16. Subjects requiring administration of any live vaccine during the screening or treatment period;\n17. Subjects with a history of allergy to the study drug, immunotherapy, or any component of related medications;\n18. Subjects with psychiatric disorders, alcoholism, inability to abstain from smoking, drug addiction, or substance abuse;\n19. Pregnant or lactating women;\n20. Adverse reactions to prior antitumor therapy not yet recovered to Grade 1 (CTCAE 5.0) (excluding alopecia);\n21. Severe uncontrolled medical conditions, or other circumstances deemed by the investigator to potentially interfere with study treatment, rendering the subject unsuitable for participation;\n22. Other conditions deemed by the investigator to preclude eligibility.",{"count":241,"type":21},[99],"The efficacy of OVV-01 injection in combination with AK112 injection in subjects with advanced soft tissue sarcoma was evaluated using ORR as the primary endpoint.",[442],"Soft Tissue Sarcoma (STS)","2026-06-14",{"date":403,"type":34},{"date":446,"type":21},"2026-08-01",{"date":365,"type":21},{"name":40,"class":41},{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":456,"targetDuration":4,"studyType":97,"phases":458,"briefSummary":459,"conditions":460,"keywords":462,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":464,"startDateStruct":465,"completionDateStruct":466,"leadSponsor":468,"locationsCount":42},"100641775","phase-1-ovv-01-intravenous-and-intratumoral-injection-combined-with-ak112-for-the-treatment-of-advanced-solid-tumors-100641775","NCT07650825","OVV-01 Intravenous and Intratumoral Injection Combined With AK112 for the Treatment of Advanced Solid Tumors","A Single-Arm, Open-Label Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of OVV-01 Administered Intravenously and Intratumorally in Combination With AK112 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. At least 18 years of age at the time of signing the ICF; gender is not restricted.\n2. Patients with advanced solid tumors confirmed by histopathological\u002Fcytological examination of the primary and\u002For metastatic lesions, including but not limited to: melanoma, head and neck squamous cell carcinoma, cervical cancer, osteosarcoma, nasopharyngeal carcinoma, breast cancer, lung cancer, colorectal cancer, hepatocellular carcinoma, gastric cancer, etc.\n3. Patients with advanced disease who have failed standard therapy, lack standard treatment options, or are medically ineligible for standard therapy. Patients must have progressed after receiving at least two standard therapies (including but not limited to targeted therapies).\n4. Subjects must have at least one measurable lesion as defined by RECIST 1.1 criteria, i.e., non-lymph node lesions ≥10 mm in longest diameter and lymph node lesions ≥15 mm in shortest diameter on CT or MRI. Injectable tumor lesions must be present, including superficial lesions and deep lesions amenable to injection under ultrasound\u002FCT\u002For endoscopic guidance.\n5. ECOG performance status of 0-1, with an estimated survival of at least 12 weeks.\n6. Sufficient organ and hematopoietic function.\n7. Women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation.\n8. Male and female subjects of childbearing potential must agree to use reliable contraception during the trial and for at least 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Patients with known brain metastases and\u002For clinically suspected brain metastases (however, patients with asymptomatic brain metastases or those clinically stable for over 3 months following local treatment may be enrolled);\n2. Subjects who underwent radiotherapy to the target lesion within the past 2 months (may be enrolled if the radiotherapy site progressed);\n3. Subjects with other active malignancies within the past 5 years. Exceptions include subjects who have achieved complete remission and require no follow-up treatment, or subjects with malignancies within the scope of the indication;\n4. Largest diameter of lesions for injection \\>100 mm;\n5. Subjects who have participated in or are currently participating in other drug or medical device clinical trials within the past 4 weeks;\n6. Subjects scheduled for or who have previously undergone tissue\u002Forgan transplantation;\n7. Subjects with Human Immunodeficiency Virus (HIV) infection who have experienced AIDS-related opportunistic infections within the past 12 months, or who have a CD4+ T-cell (CD4+) count \\\u003C 350 cells\u002FuL; Patients screening positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) with HBV-DNA above the lower limit of detection, or screening positive for HCV antibody with HCV-RNA above the lower limit of detection; subjects with positive syphilis serology;\n8. Subjects requiring antiviral therapy during the study period or within 5 half-lives of the first dose of antiviral therapy.\n9. Subjects requiring therapeutic anticoagulant therapy during the study period.\n10. Subjects with uncontrolled active infection ≥ Grade 3 according to CTCAE v5.0 that is clinically significant;\n11. Received antineoplastic therapy (chemotherapy, radiotherapy, biologic therapy, endocrine therapy, immunotherapy, etc.) within 4 weeks prior to first dose; Received small-molecule targeted therapy or oral fluorouracil-based agents within 2 weeks prior to first dose or within 5 half-lives (whichever is longer); Received Chinese herbal medicine or proprietary Chinese medicine with antitumor indications within 2 weeks prior to the first dose; Received nitrosourea or mitomycin C within 6 weeks prior to the first dose; Palliative radiotherapy for non-target lesions is permitted (≥2 weeks prior to the first dose);",{"count":457,"type":21},30,[243],"This study is an open-label, multiple-route-of-administration dose-escalation clinical trial designed to evaluate the safety and preliminary efficacy of OVV-01 injection administered intravenously or intravenously plus intratumorally, either as monotherapy or in combination with AK112 injection, in subjects with advanced solid tumors.",[461],"Advanced Solid Tumors",[463,307],"oncolytic virus",{"date":403,"type":34},{"date":446,"type":21},{"date":467,"type":21},"2027-01-31",{"name":40,"class":41},{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":97,"phases":478,"briefSummary":480,"conditions":481,"keywords":485,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":42},"100641388","early-phase-1-qh101-cell-injection-in-patients-with-brain-brain-spinal-meninges-and-spinal-cord-metastatic-malignant-solid-tumors-100641388","NCT07656103","QH101 Cell Injection in Patients With Brain, Brain (Spinal) Meninges, and Spinal Cord Metastatic Malignant Solid Tumors","Exploratory Clinical Study of Dose Escalation for QH101 Cell Injection in Patients With Brain, Brain (Spinal) Meninges, and Spinal Cord Metastatic Malignant Solid Tumors Three Dose Groups Are Established: 1×10⁷ enTCR Vδ2T Cells Per Infusion (Low Dose), 3×10⁷ enTCR Vδ2T Cells Per Infusion (Medium Dose), and 6×10⁷ enTCR Vδ2T Cells Per Infusion (High Dose). The Dose Escalation Rules Are as Follows: The First Enrolled Subject Receives Low-dose Cell Infusion. If no Dose-limiting Toxicity (DLT) Events Occur After Infusion, the Second Enrolled Subject Receives Medium-dose Infusion; the Medium and Hig","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. ECOG ≤2 or KPS ≥60;\n3. Life expectancy ≥8 weeks as assessed by the investigator;\n4. Pathologically and\u002For histologically confirmed malignant tumors with brain, meningeal, and spinal cord metastases that have failed standard therapy or lack standard treatment options may be considered for enrollment;\n5. Intracranial metastases must meet the following characteristics:\n\n   Unresectable by craniotomy for solitary\u002Ffocal (≤3 lesions)\u002Fmultiple (\\>3 lesions) intracranial metastases; or inoperable leptomeningeal or spinal cord metastases; Inclusion Criteria Intracranial lesions that progressed after standard treatment, including whole-brain radiotherapy\u002Fstereotactic radiosurgery (WBRT\u002FSRS), and are not suitable for repeat radiotherapy;\n6. For brain\u002Fspinal cord parenchymal metastases, contrast-enhanced MRI must show at least one measurable lesion (according to iRANO criteria); for patients with meningeal lesions only, those deemed likely to benefit from this study by investigator judgment may also be considered for inclusion (efficacy assessed using RANO-LM criteria);\n7. Basic normal bone marrow reserve function and normal hepatic and renal function (laboratory tests must meet the following criteria prior to first QH101 administration):\n\n   White blood cell count (WBC) ≥ 3 × 10⁹\u002FL; Lymphocyte count (LY) ≥ 0.8 × 10⁹\u002FL; Hemoglobin (Hb) ≥ 90 g\u002FL; Platelet count (PLT) ≥ 90 × 10⁹\u002FL; Alanine aminotransferase (ALT) \\& aspartate aminotransferase (AST) \\\u003C 1.5×ULN; Serum creatinine (Cr) \\\u003C 1.5×ULN; Total bilirubin \\\u003C 1.5×ULN; PT \\& APTT ≤ 1.25×ULN.\n8. Pregnancy test must be negative for women of childbearing potential; both male and female subjects must agree to use effective contraception during treatment and for 1 year thereafter;\n9. Ability to understand trial requirements and procedures, and willingness to participate in the clinical study as required;\n10. Signing of the trial informed consent form.\n\nExclusion Criteria:\n\n1. Received central nervous system-directed radiation within 7 days prior to the first infusion of QH101;\n2. Patients with hematologic malignancies (such as lymphoma, leukemia, etc.) with central nervous system metastases;\n3. Patients with metastases in the brainstem and high cervical spinal cord, including midbrain, pons, medulla oblongata, and C1\u002F2 segments of the cervical spinal cord;\n4. Patients with significant mass effect from intracranial lesions and signs of increased intracranial pressure (such as severe headache, projectile vomiting, papilledema, altered consciousness, or imaging showing significant edema, midline shift ≥1 cm, compression of peribrain cisterns such as suprasellar cistern, quadrigeminal cistern, interpeduncular cistern, or ambient cistern);\n5. Patients with primary or secondary epilepsy\u002Fepileptic syndrome that is difficult to control with medication;\n6. Uncontrolled comorbidities, including but not limited to: ongoing or active infections, symptomatic congestive heart failure, unstable angina, arrhythmias, or psychiatric\u002Fsocial conditions limiting patient compliance with study requirements;\n7. Known psychiatric disorders or substance abuse disorders that may affect compliance with trial requirements;\n8. Currently receiving any other investigational treatments;\n9. Diagnosed with an immunodeficiency;\n10. Patients with active infections requiring systemic treatment;\n11. Inability to undergo magnetic resonance imaging (MRI);\n12. Severe cardiovascular damage: history of New York Heart Association (NYHA) class II or higher congestive heart failure, unstable angina, myocardial infarction or stroke within 6 months after first dosing, or clinically significant arrhythmias requiring treatment at screening;\n13. Allergic to immunotherapy or related cellular therapies;\n14. Previously received CAR-T or other cellular immunotherapies;\n15. Other reasons that the investigator considers make the patient unsuitable for participation in this study.",{"count":477,"type":21},7,[479],"EARLY_PHASE1","QH101 is an allogeneic TCR-enhanced Vδ2 T cell therapy product engineered to express BTN protein-specific binding elements on the cell surface. This innovative approach harnesses the natural cytotoxic capabilities of Vδ2 T cells while augmenting their ability to recognize BTN proteins, thereby significantly improving tumor cell elimination efficiency. Notably, QH101 is designed without co-stimulatory signal domains or the CD3ζ domain, which prevents T cell exhaustion from overactivation and effectively enhances in vivo persistence.",[482,483,484],"Brain Metastasis","Meningeal Metastasis","Spinal Cord Metastasis",[486,487,488,489],"TCR","BTN","γδT","allogeneic cell therapy",{"date":491,"type":34},"2026-06-18",{"date":493,"type":21},"2026-05-31",{"date":495,"type":21},"2027-05-31",{"name":40,"class":41},{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":505,"targetDuration":4,"studyType":97,"phases":506,"briefSummary":507,"conditions":508,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":512,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":4},"100641305","early-phase-1-inhaled-mrna-immunotherapy-for-patients-with-advanced-lung-cancer-or-pulmonary-metastatic-solid-tumors-100641305","NCT07657611","Inhaled mRNA Immunotherapy for Patients With Advanced Lung Cancer or Pulmonary Metastatic Solid Tumors","A Platform Study of In Vivo Inhaled mRNA Technology for Multi-Target Immunotherapy Against Solid Tumors","BMD-PLAT","Inclusion Criteria:\n\n1. Male or female patients aged ≥ 18 years.\n2. Confirmed diagnosis of advanced lung cancer (driver gene negative or targeted therapy failed) or pulmonary metastatic solid tumors, with no standard treatment options available or who have failed prior standard therapies.\n3. Presence of at least one measurable lesion according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Adequate organ function, including hematologic, hepatic, and renal function.\n6. Ability to understand and sign the informed consent form.\n7. Expected survival of at least 12 weeks.\n\nExclusion Criteria:\n\n1. History of severe hypersensitivity to mRNA-based therapies or components of the study drug.\n2. Uncontrolled active infection or severe underlying respiratory disease (e.g., severe COPD, asthma requiring high-dose steroids).\n3. Prior allogeneic stem cell or solid organ transplantation.\n4. Current use of other investigational agents within 4 weeks before the first dose of study treatment.\n5. Active autoimmune disease requiring systemic immunosuppressive therapy.\n6. Pregnant or breastfeeding women.\n7. Any condition that, in the investigator's opinion, would interfere with study compliance or safety.",{"count":177,"type":21},[479],"This is an open-label phase I master platform study to evaluate the safety, tolerability and preliminary anti-tumor efficacy of multiple inhaled in-vivo mRNA immunotherapies in adult patients with advanced solid tumors. Subjects will receive inhalation mRNA formulations at ascending dose levels following a 3+3 dose-escalation design to determine maximum tolerated dose and recommended phase II dose.",[509,510,511],"Neoplasms","Solid Tumors","Neoplasm Metastasis",{"date":491,"type":34},{"date":514,"type":21},"2026-06-10",{"date":516,"type":21},"2029-12",{"name":40,"class":41},{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":525,"targetDuration":4,"studyType":97,"phases":527,"briefSummary":528,"conditions":529,"keywords":531,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":532,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":536,"locationsCount":42},"100641261","phase-1-platform-study-of-vsv-based-recombinant-oncolytic-viruses-for-the-treatment-of-advanced-malignant-tumors-100641261","NCT07656116","Platform Study of VSV-Based Recombinant Oncolytic Viruses for the Treatment of Advanced Malignant Tumors","A Phase I Platform Study of VSV-Based Recombinant Oncolytic Viruses for the Treatment of Advanced Malignant Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form, understand this study, and agree to comply with the protocol and complete all trial procedures\n2. Be at least 18 years of age at the time of signing the ICF, with no gender restrictions.\n3. Patients with advanced solid tumors confirmed by histopathological\u002Fcytological examination of primary and\u002For metastatic lesions.\n4. Patients who have failed standard therapy, lack a standard last-line treatment option, or are medically ineligible for standard therapy.\n5. Subjects with an ECOG performance status of 0-2 and an estimated survival of ≥12 weeks.\n6. Adequate organ and hematopoietic function: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FLPlatelet count ≥ 75 × 10⁹\u002FL (no platelet transfusion or thrombopoietin (TPO) therapy within 2 weeks prior to first dose)Hemoglobin ≥ 90 g\u002FL (no blood transfusion within 2 weeks)Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (CCr) ≥ 50 mL\u002Fmin Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN for patients with liver metastases, AST and ALT \\\u003C 5 × ULN， Serum total bilirubin (TBIL) ≤ 2 × ULN， International Normalized Ratio (INR) ≤ 1.5 × ULN, or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN\n7. Women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation.\n8. Male and female subjects of reproductive potential must agree to use reliable contraception during the trial and for at least 6 months after the last dose. Translated with DeepL.com (free version)\n\nExclusion Criteria:\n\n1. Subjects with other active malignancies within the past 5 years. Exceptions include subjects who have achieved complete remission and require no follow-up treatment, and subjects with malignancies within the scope of the indication.\n2. Lesions intended for injection with a maximum diameter \\>100 mm；\n3. Subjects who have participated in or are currently participating in other drug or medical device clinical trials within the past 4 weeks；\n4. Subjects scheduled for or who have previously undergone tissue\u002Forgan transplantation；\n5. Subjects with Human Immunodeficiency Virus (HIV) infection who have experienced AIDS-related opportunistic infections within the past 12 months, or who have a CD4+ T-cell (CD4+) count \\\u003C 350 cells\u002FuL Patients with positive hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) at screening, with HBV-DNA above the lower limit of detection patients with positive HCV antibody at screening and HCV-RNA above the lower limit of detection subjects with positive syphilis serology\n6. Subjects requiring antiviral medication during the study period or within 5 half-lives of antiviral medication at the time of first dosing.\n7. Subjects requiring therapeutic anticoagulant medication during the study period.\n8. Subjects with uncontrolled active infection of ≥Grade 3 severity according to CTCAE v5.0 that is clinically significant\n9. Received antineoplastic therapy (chemotherapy, radiotherapy, biologic therapy, endocrine therapy, immunotherapy, etc.) within 4 weeks prior to first dose Received small-molecule targeted therapy or oral fluorouracil-based agents within 2 weeks prior to first dose or within 5 half-lives (whichever is longer) Received Chinese herbal medicine or proprietary Chinese medicine with antitumor indications within 2 weeks prior to first dose Received Chinese herbal medicine or proprietary Chinese medicine with antitumor indications within 2 weeks prior to first dose Received nitrosourea or mitomycin C within 6 weeks prior to first dose Palliative radiotherapy for non-target lesions is permitted (≥2 weeks prior to first dose)\n10. Uncontrolled hypertension, pulmonary hypertension, or unstable angina myocardial infarction, coronary artery bypass grafting, or stenting within 6 months prior to dosing history of chronic heart failure at New York Heart Association (NYHA) functional class III-IV Severe arrhythmias requiring treatment (excluding atrial fibrillation or paroxysmal supraventricular tachycardia deemed by the investigator to have no impact on the trial), including QTcF ≥ 450 ms in males or ≥ 470 ms in females (calculated using Fridericia's formula) cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to enrollment",{"count":526,"type":21},27,[243],"To evaluate the safety and tolerability of combined administration of VSV injection solutions carrying different targets via multiple routes for treating advanced malignant solid tumors.",[530],"Advanced Solid Tumor",[463,307],{"date":491,"type":34},{"date":534,"type":34},"2026-01-29",{"date":467,"type":21},{"name":40,"class":41},{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":18,"enrollmentInfo":544,"targetDuration":4,"studyType":97,"phases":546,"briefSummary":547,"conditions":548,"keywords":550,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":554,"startDateStruct":555,"completionDateStruct":556,"leadSponsor":558,"locationsCount":42},"100641219","phase-1-cib-in-vivo-car-t-lentiviral-injection-in-patients-with-advanced-malignant-tumors-100641219","NCT07657585","CIB In Vivo CAR-T Lentiviral Injection in Patients With Advanced Malignant Tumors","A Phase 1, Open-Label, Single-Arm, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CIB In Vivo CAR-T Lentiviral Injection in Patients With Advanced Malignant Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 75 years.\n2. At least one measurable target lesion according to RECIST version 1.1 at screening.\n3. Histologically or cytologically confirmed advanced or metastatic malignant tumor, with positive target expression confirmed by validated assay methods.\n4. Patients who have failed prior standard systemic therapy (including but not limited to VEGF-targeted tyrosine kinase inhibitors and\u002For immune checkpoint inhibitors), or are intolerant to standard therapy.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Expected survival time ≥ 3 months as assessed by the investigator.\n7. Adequate organ function at baseline (no growth factor support or transfusion within 14 days prior to screening):\n\n   a. Bone marrow function: i. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; ii. Hemoglobin (Hb) ≥ 90 g\u002FL; iii. Platelet count (PLT) ≥ 75 × 10⁹\u002FL. b. Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN); if liver metastases are present, ALT and AST ≤ 5 × ULN; total bilirubin (TBIL) ≤ 1.5 × ULN.\n\n   c. Renal function: Serum creatinine ≤ ULN or creatinine clearance rate ≥ 80 mL\u002Fmin.\n8. For female patients of childbearing potential, serum β-HCG test result must be negative within 7 days prior to enrollment.\n9. Patients must agree to use effective contraception from the signing of the informed consent form (ICF) until at least 90 days after the end of the study.\n10. Voluntarily sign the informed consent form (ICF) and be able to understand and comply with the requirements of the study protocol.\n\nExclusion Criteria:\n\n1. Asymptomatic untreated brain metastases; symptomatic central nervous system (CNS) metastases or carcinomatous meningitis; or other evidence of uncontrolled CNS\u002Fmeningeal metastases that are considered unsuitable for enrollment by the investigator.\n2. Presence of clinically significant cardiovascular, pulmonary, neurological, or systemic disease at baseline that may increase study participation risk or interfere with safety assessments.\n3. Presence of severe chronic or active infection at baseline, including:\n\n   1. Active hepatitis B (HBsAg positive with HBV DNA \\> ULN);\n   2. Active hepatitis C (anti-HCV positive with detectable HCV RNA);\n   3. Known history of or positive test for human immunodeficiency virus (HIV);\n   4. Systemic anti-infective therapy required within 4 weeks prior to first administration, including hospitalization for infectious complications, bacteremia, severe pneumonia, or active tuberculosis.\n4. History of active autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis) or receipt of long-term systemic corticosteroids (prednisone \\> 10 mg\u002Fday or equivalent) or other immunosuppressive agents within 4 weeks prior to first administration.\n5. Prior allogeneic tissue or solid organ transplantation.\n6. Evidence of severe immunodeficiency, such as primary immunodeficiency (e.g., severe combined immunodeficiency, SCID) or concurrent opportunistic infections.\n7. Prior gene therapy using lentiviral or retroviral vectors.\n8. Prior treatment with drugs targeting the same antigen.\n9. Requiring therapeutic anticoagulation that cannot be discontinued prior to administration.\n10. History of severe cardiovascular disease, including:\n\n    1. NYHA class ≥ II congestive heart failure;\n    2. Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n    3. Corrected QT interval (QTcF) \\> 470 ms or long QT syndrome;\n    4. Acute coronary syndrome, aortic dissection, severe arrhythmia, stroke, or other grade ≥ 3 cardiovascular events within 6 months prior to first administration;\n    5. Uncontrolled hypertension.\n11. Prior anti-tumor therapy within 4 weeks or 5 half-lives (whichever is longer) prior to first administration, including chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy; prior oral small-molecule targeted therapy within 2 weeks or 5 half-lives (whichever is longer); prior palliative radiotherapy within 14 days; prior participation in other anti-tumor clinical trials within 4 weeks; prior use of any anti-tumor traditional Chinese medicine within 2 weeks.\n12. Pregnant or breastfeeding women, or women of childbearing potential who refuse to use effective contraception during the study period.\n13. Any other disease or laboratory abnormality that, in the investigator's opinion, makes the patient unsuitable for participation in this study.",{"count":545,"type":21},91,[243],"This is an open-label, single-arm, phase 1 dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CIB in vivo CAR-T lentiviral injection in patients with advanced malignant tumors.\n\nThe study will enroll patients with histologically or cytologically confirmed advanced solid tumors that have progressed on or are intolerant to standard therapies. A \"3+3\" dose-escalation design will be used, with planned dose levels including 1×10⁵ TU\u002Fkg, 3×10⁵ TU\u002Fkg, 1×10⁶ TU\u002Fkg, 3×10⁶ TU\u002Fkg, 1×10⁷ TU\u002Fkg, and 3×10⁷ TU\u002Fkg. The primary objective is to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) based on dose-limiting toxicities (DLTs) observed within 28 days after administration. Secondary objectives include evaluating adverse events, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and pharmacokinetic parameters of the study drug.",[549],"Advanced Malignant Solid Tumors",[461,551,552,553],"In Vivo CAR-T","Phase 1 Study","Dose Escalation",{"date":491,"type":34},{"date":284,"type":21},{"date":557,"type":21},"2028-05-31",{"name":40,"class":41},{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":97,"phases":568,"briefSummary":569,"conditions":570,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":572,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":576,"locationsCount":42},"100641209","phase-1-prospective-randomized-controlled-clinical-study-of-acupoint-application-with-gutong-plaster-in-the-treatment-of-moderate-to-severe-cancer-pain-100641209","NCT07657390","Prospective Randomized Controlled Clinical Study of Acupoint Application With Gutong Plaster in the Treatment of Moderate to Severe Cancer Pain","A Prospective Randomized Controlled Clinical Trial of Acupoint Application With Gutong Plaster for Moderate to Severe Cancer Pain","Inclusion Criteria:\n\n1. The subject has signed the informed consent form.\n2. Age ≥ 18 years, including males and females.\n3. According to the investigator's assessment, the subject has relatively stable cancer pain and requires continuous analgesic medication (estimated treatment duration ≥ 2 weeks).\n4. Estimated life expectancy ≥ 3 months.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3.\n6. Adequate organ function.\n7. Patients with moderate to severe cancer pain, defined as 4 ≤ NRS (Numeric Rating Scale) score ≤ 8.\n\nExclusion Criteria:\n\n1. Known allergy to any active ingredient or excipient of the study drug, or a history of allergy to other opioids and their related components.\n2. Persistent pain caused by other diseases or unknown causes.\n3. Subjects presenting with urgent symptoms such as intestinal obstruction\u002Fperforation, spinal cord compression, or pathological fracture.\n4. History of severe psychiatric disorders, such as schizophrenia and depression.\n5. Patients currently receiving chemotherapy or still in the chemotherapy reaction period (patients in the chemotherapy interval may be included. That is, patients who have completed chemotherapy for more than 1 week can be enrolled, or patients who have just finished chemotherapy may be enrolled at the investigator's discretion).\n6. Patients who have received radiotherapy to the pain area within 4 weeks before enrollment (those who have received radiotherapy to areas other than the pain area may be included), or those who plan to receive radiotherapy to the pain area during the study.\n7. Other conditions deemed unsuitable for participation in this study by the investigator, such as poor compliance.",{"count":567,"type":21},198,[243,99],"This clinical trial aims to evaluate the efficacy and safety of acupoint application with Gutong Plaster for treating moderate to severe cancer pain in patients aged ≥18 years with moderate to severe cancer pain (NRS 4-8), ECOG 0-3, life expectancy ≥3 months. The main questions it aims to answer are:\n\nDoes acupoint application with Gutong Plaster improve the response rate (CR + PR) in patients with moderate to severe cancer pain? Does Gutong Plaster reduce pain intensity (NRS score) and opioid consumption in cancer pain patients? Researchers will compare patients receiving oxycodone plus Gutong Plaster to patients receiving oxycodone plus placebo simulant to see if Gutong Plaster provides better pain relief and lower opioid use.\n\nParticipants will:\n\nReceive standard treatment with oxycodone prolonged-release tablets Be randomly assigned to receive Gutong Plaster or placebo simulant via acupoint application twice daily for 14 days Undergo pain assessment, quality of life evaluation, safety laboratory tests, and follow-up at specified time points",[571],"Cancer Pains",{"date":491,"type":34},{"date":574,"type":34},"2025-12-25",{"date":167,"type":21},{"name":40,"class":41},{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":97,"phases":586,"briefSummary":587,"conditions":588,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":590,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":594,"locationsCount":42},"100641182","predictive-value-of-tumor-microenvironment-petct-for-response-and-prognosis-in-aggressive-lymphoma-a-multicenter-study-100641182","NCT07657494","Predictive Value of Tumor Microenvironment PET\u002FCT for Response and Prognosis in Aggressive Lymphoma: A Multicenter Study","The Predictive Value of Tumor Microenvironment PET\u002FCT Imaging for Treatment Response and Prognosis in Aggressive Lymphoma: A Multicenter Clinical Study","Inclusion Criteria:\n\n* Histologically confirmed aggressive lymphoma.\n* Baseline PET\u002FCT showing moderate to high FDG uptake in lymphoma lesions.\n* No previous history of malignant tumors.\n* No significant cardiac, hepatic, or renal dysfunction.\n* Expected survival of at least 6 months and ability to complete follow-up.\n\nExclusion Criteria:\n\n* Low FDG uptake on baseline PET\u002FCT.\n* Lymphoma lesions have been surgically removed, with no positive lesions available for evaluation.\n* Active or uncontrolled chronic inflammation or infection.\n* Uncontrolled diabetes mellitus.\n* Incomplete clinical data or loss to follow-up.\n* Refusal to sign the informed consent form.\n* Inability to lie supine for 30 minutes.",{"count":585,"type":21},94,[122],"This multicenter study aims to evaluate the predictive value of tumor microenvironment PET\u002FCT imaging for treatment response and prognosis in patients with aggressive lymphoma. Eligible patients with histologically confirmed aggressive lymphoma will undergo FAPI PET\u002FCT imaging, and selected patients who are candidates for immunotherapy will undergo Grazytracer PET\u002FCT imaging. These imaging methods are intended to assess fibroblast activation protein expression and granzyme B activity in lymphoma lesions, reflecting cancer-associated fibroblasts and cytotoxic T-cell activity in the tumor microenvironment. The study will explore optimal imaging assessment criteria and develop clinical-pathological-imaging models to predict treatment response, prognosis, and the relationship between tumor heterogeneity and refractory or relapsed disease.",[589],"Aggressive Lymphoma",{"date":491,"type":34},{"date":592,"type":34},"2024-07-11",{"date":167,"type":21},{"name":40,"class":41},""]