[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-positive-advanced-gastric-cancer-or-gastroesophageal-junction-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-positive-advanced-gastric-cancer-or-gastroesophageal-junction-adenocarcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100630693","phase-2-disitamab-vedotin-combined-with-sintilimab-and-multimodal-radiotherapy-for-her2-positive-advanced-gastric-cancer-after-second-line-treatment-failure-a-prospective-single-arm-phase-ii-clinical-trial-100630693",false,"NCT07490990","Disitamab Vedotin Combined With Sintilimab and Multimodal Radiotherapy for HER2-Positive Advanced Gastric Cancer After Second-Line Treatment Failure: A Prospective, Single-Arm Phase II Clinical Trial","Inclusion criteria\n\n1. Age: 18-75 years.\n2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n3. Liver function: Child-Pugh class A.\n4. Histopathologically confirmed advanced gastric cancer with HER2-positive status, defined as HER2 IHC 2+ or 3+, as determined by central laboratory testing.\n5. Failure of or intolerance to standard first-line and second-line treatments.\n6. At least one measurable lesion based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). If a lesion has previously received local therapy, it may be considered measurable only when unequivocal disease progression has been confirmed. In addition, patients should have at least two measurable lesions suitable for radiotherapy, separate from the RECIST target lesions whenever feasible.\n7. Patients with controlled hepatitis B virus (HBV) infection are eligible if they have received anti-HBV therapy for at least 1 month before the first dose of study medication, and have an HBV viral load \\\u003C 2000 IU\u002FmL (10 000 copies\u002FmL) before the first dose. Patients receiving ongoing anti-HBV therapy must maintain the same regimen throughout the study treatment period.\n8. Major organ function must meet the following criteria within 28 days before treatment initiation:\n\n1)Hematological parameters, without blood transfusion within the preceding 14 days: hemoglobin (HB) ≥ 80 g\u002FL; absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; platelet count (PLT) ≥ 80 × 10⁹\u002FL.\n\n2)Biochemical parameters: Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, or ≤ 5 × ULN in subjects with liver metastasis; Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL\u002Fmin.\n\n3)Coagulation parameters: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. For subjects on anticoagulant therapy, PT and APTT within the therapeutic range are acceptable.\n\n4)Thyroid function: Normal T3 and T4 levels. (9)Women of childbearing potential must agree to use effective contraception during the study and for 120 days after the last dose of study treatment. A negative serum or urine pregnancy test is required within 7 days before study enrollment.\n\n(10) Patients must provide written informed consent before enrollment. Exclusion Criteria\n\n1. History of other malignant tumors within the past 5 years or concurrent other malignancies, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, or papillary thyroid carcinoma.\n2. History of anaphylaxis or severe hypersensitivity to disitamab vedotin, sintilimab, or any excipients of these drugs.\n3. Prior treatment with disitamab vedotin or sintilimab.\n4. Patients with symptomatic central nervous system metastases.\n5. Patients receiving treatment with a strong CYP3A4 inhibitor within 1 week before enrollment, or treatment with a strong CYP3A4 inducer within 2 weeks before enrollment.\n6. Congestive heart failure classified as New York Heart Association (NYHA) functional class III-IV.\n7. History of an ischemic cardiovascular event within 1 year before enrollment.\n8. Ongoing systemic immunosuppressive therapy.\n9. Participation in another interventional clinical trial of investigational medicinal products within 4 weeks before the first dose of study medication.\n10. Requirement for systemic corticosteroids, equivalent to \\> 10 mg prednisone per day, or other immunosuppressive agents within 2 weeks before the first dose of study medication.\n11. Administration of an antitumor vaccine or a live attenuated vaccine within 4 weeks before the first dose of study medication.\n12. Patients with severe infection within 4 weeks before the first dose of study medication.\n13. Active autoimmune disease or history of autoimmune disease and history of immunodeficiency.\n14. Active pulmonary tuberculosis, history of active pulmonary tuberculosis within 1 year before enrollment, or history of active pulmonary tuberculosis more than 1 year before enrollment without standard anti-tuberculosis treatment.\n15. Active viral hepatitis: HBV DNA ≥ 2000 IU\u002FmL (10 000 copies\u002FmL); or hepatitis C virus (HCV) infection, defined as positive anti-HCV antibody and HCV-RNA above the lower limit of detection of the assay.\n16. Known history of psychotropic substance abuse, alcoholism, or illicit drug use.\n17. Pregnancy or breastfeeding women.","ALL","18 Years","75 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Patients with HER2-positive advanced gastric cancer who experience disease progression after standard first- and second-line therapies have limited subsequent treatment options. Disitamab vedotin, a novel anti-HER2 antibody-drug conjugate (ADC), has been approved in China for this patient population. Immune checkpoint inhibitors (ICIs) serve as a core therapeutic modality for advanced gastric cancer; however, treatment discontinuation often occurs due to disease progression or immune-related adverse events, which raises clinical demands for immunotherapy rechallenge. Preclinical and early clinical evidence suggests that disitamab vedotin may remodel the tumor immune microenvironment and generate synergistic anti-tumor activity with PD-1 blockade. Furthermore, multimodal radiotherapy combining low-dose radiotherapy (LDRT) and high-dose hypofractionated radiotherapy (HFRT) can enhance systemic anti-tumor immunity through tumor antigen release and remodeling of the tumor immune microenvironment.\n\nThis prospective, multicenter, interventional, single-arm phase II clinical study aims to evaluate the efficacy and safety of disitamab vedotin combined with sintilimab and multimodal radiotherapy in patients with HER2-positive advanced gastric cancer with progression following first- and second-line systemic therapy. Eligible participants will receive protocol-specified disitamab vedotin and sintilimab, followed by multimodal radiotherapy delivered to at least two independent lesions. The primary endpoint is progression-free survival (PFS) assessed according to RECIST v1.1. Secondary endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety profile. Exploratory biomarker analyses will be conducted using matched tumor tissue and peripheral blood specimens. A total of 30 participants will be enrolled. This trial is conducted in accordance with the Declaration of Helsinki and relevant Chinese biomedical research regulations. All enrolled patients will provide written informed consent, and the study has obtained ethical approval from the Ethics Committee of West China Hospital, Sichuan University.",[26],"HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma","NOT_YET_RECRUITING","2026-07-30",{"date":30,"type":31},"2026-08-03","ACTUAL",{"date":33,"type":20},"2026-06",{"date":35,"type":20},"2028-12",{"name":37,"class":38},"West China Hospital","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"100525573","phase-3-shr-a1811-for-subjects-with-her2-positive-gastric-cancer-and-gastroesophageal-junction-adenocarcinoma-after-progression-on-or-after-first-line-anti-her2-therapy-containing-regimen-100525573","NCT06123494","SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing Regimen","A Phase 3, Multicenter, Randomized, Open-label Study of SHR-A1811 (HER2-ADC) Compared With the Chemotherapy Treatment Chosen by the Investigators for Subjects With HER2-positive Metastatic and\u002For Unresectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma Who Have Progressed on or After First-line Anti-HER2 Therapy-containing Regimen","Inclusion Criteria:\n\n1. Age 18-75 years old, male and female;\n2. Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma, and unresectable locally advanced or metastatic disease\n3. Prior anti-HER-2 containing treatment\n4. Progression on or after first-line standard treatment (Prior neoadjuvant or adjuvant therapy can be counted as a line of therapy if the subject progressed on or within 6 months of completing neoadjuvant or adjuvant therapy);\n5. Centrally confirmed HER2-positive (IHC 3+ or IHC 2+ and evidence of HER2 amplification by ISH) as classified by ASCO-CAP on a tumor biopsy\n6. At least one measurable lesion according to the solid tumor response Evaluation Criteria (RECIST 1.1);\n7. ECOG: 0-1;\n8. Expected survival ≥12 weeks;\n9. Good blood reserve and liver, kidney and coagulation function;\n10. Willing to provide informed consent for study participation.\n\nExclusion Criteria:\n\n1. Receive the last dose of anti-cancer therapy(including chemotherapy, radiotherapy, biological therapy, targeted therapy or immunotherapy) within 4 weeks, prior to the first dose;\n2. Known allergies to monoclonal antibodies and inactive ingredients of this product, and allergies to paclitaxel, docetaxel, and irinotecan concurrently;\n3. The toxicity of prior anti-tumor therapy did not recover to the level specified by CTCAE v5.0 grade evaluation ≤ Grade 1 or inclusion\u002Fexclusion criteria;\n4. Clinically active central nervous system metastases;\n5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n6. Clinically significant gastrointestinal disorder by the opinion of Investigator;\n7. Has a history of immunodeficiency, including a positive HIV test;\n8. During the screening visits and before the first dose, unexplained fever \\> 38.5℃, severe infection (CTC-AE \\> Grade 2), and active pulmonary inflammation were indicated by screening imaging;\n9. Subjects with interstitial pneumonia or with ≥ grade 3 interstitial pneumonia during prior treatment with immune checkpoint inhibitors;\n10. Active hepatitis B(HBV DNA ≥ 500 IU\u002FmL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA above the lower limit of detection of the analytical method);\n11. Clinically significant cardiovascular disease ,such as severe\u002Funstable angina, symptomatic congestive heart failure (NYHA ≥ Class II.), clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention, myocardial infarction within 6 months before the first dose, cerebrovascular accident (including transient ischemic attack); QTcF of 12-lead ECG was ≥470 ms; Left ventricular ejection fraction \\\u003C50%; Clinically uncontrolled hypertension;\n12. Had other malignancies with 5 years;\n13. Pregnant or lactating women;\n14. Other factors that might have led to drop out the study by the investigator opinion.",{"count":47,"type":20},360,[49],"PHASE3","This study will assess the efficacy and safety of SHR-A1811 compared with treatment chosen by the investigator in participants with HER2-positive (defined as immunohistochemistry \\[IHC\\] 3+ or IHC 2+\u002Fin situ hybridization \\[ISH\\]+) gastric or GEJ adenocarcinoma (based on \\[American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines who have progressed on or after a first-line anti-HER2 therapy-containing regimen.",[26],"RECRUITING","2024-01-11",{"date":55,"type":31},"2024-01-16",{"date":57,"type":31},"2024-01-09",{"date":59,"type":20},"2027-06-30",{"name":61,"class":62},"Jiangsu HengRui Medicine Co., Ltd.","INDUSTRY",1]