[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-positive-gastric-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-positive-gastric-cancer":337},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,41,66,89,117,147,174,194,218,248,274,294,319],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100574868","phase-3-a-phase--study-of-rilvegostomig-in-combination-with-fluoropyrimidine-and-trastuzumab-deruxtecan-as-the-first-line-treatment-for-her2-positive-gastric-cancer-100574868",false,"NCT06764875","A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer","A Randomized, Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan Versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First Line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01)","Inclusion Criteria:\n\n1. HER2 positive for gastric cancer on a tumor biopsy.\n2. PD-L1 combined positive score (CPS) ≥ 1.\n3. Provision of tumor tissue sample from recent biopsy adequate for HER2 and PD-L1 testing.\n4. Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma.\n5. WHO or Eastern Cooperative Oncology Group performance status of 0 or 1.\n6. Have measurable target disease assessed by the Investigator based on RECIST v1.1.\n7. Have adequate organ and bone marrow function.\n8. LVEF ≥ 50% within 28 days before randomization.\n9. Adequate treatment washout period before randomization.\n\nExclusion Criteria:\n\n1. Lack of physiological integrity of the upper gastrointestinal tract.\n2. Known dihydropyrimidine dehydrogenase enzyme deficiency.\n3. Contraindication to pembrolizumab or trastuzumab, contraindications to fluoropyrimidine (5-FU and capecitabine) or platinum (cisplatin and oxaliplatin) treatment as per local label.\n4. History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence.\n5. Persistent toxicities caused by previous anti-cancer therapy.\n6. Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring corticosteroid or anticonvulsant may be included in the study if they have recovered from the acute toxic effect of radiotherapy.\n7. Uncontrolled infection including tuberculosis and active hepatitis A infection.\n8. Uncontrolled infection requiring intravenous (IV) antibiotics, anti-virals, or antifungals.\n9. Recent receipt of live, attenuated vaccine.\n10. Chronic\u002Factive HBV or HCV infection unless controlled.\n11. Clinically significant cardiac or psychological conditions.\n12. Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.\n13. History of (non-infectious) ILD\u002Fpneumonitis, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n14. Lung-specific intercurrent clinically significant illnesses.\n15. Any active non-infectious skin disease requiring systemic treatment.\n16. A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART).\n17. History of any of the following: drug-induced severe cutaneous adverse reaction.\n18. Any concurrent antic-ancer treatment with the exception of receptor activator of nuclear factor kappa-B ligand inhibitors.\n19. Have had major surgical procedure recently (excluding placement of vascular access) or recent significant traumatic injury or an anticipated need for major surgery during the study.\n20. Current or prior use of immunosuppressive medication within 14 days before study intervention.","ALL","18 Years",{"count":19,"type":20},840,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a Phase Ⅲ, randomized, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm.",[26,27],"HER2-positive Gastric Cancer","Gastroesophageal Junction Adenocarcinoma","RECRUITING","2026-06-15",{"date":31,"type":32},"2026-06-16","ACTUAL",{"date":34,"type":32},"2025-03-01",{"date":36,"type":20},"2030-12-09",{"name":38,"class":39},"AstraZeneca","INDUSTRY",293,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100556968","phase-3-a-phase--clinical-study-of-hlx22-in-combination-with-trastuzumab-and-chemotherapy-for-the-treatment-of-gastroesophageal-junction-and-gastric-cancer-100556968","NCT06532006","A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer","A Randomized, Double-blinded, Multicenter, Phase Ⅲ Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Trastuzumab and Chemotherapy (XELOX) With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer","Inclusion Criteria:\n\n1. Male\u002Ffemale who are at least 18 years of age on the day of signing the informed consent.\n2. With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.\n3. Had measurable disease as assessed by IRRC according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.\n4. HER2-positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH+ or FISH, as assessed by a central laboratory on a primary or metastatic tumor.\n5. ECOG PS within 7 days before randomization: 0-1.\n6. Expected survival ≥ 6 months.\n7. Had adequate organ function\n\nExclusion Criteria:\n\n1. Patients with other malignant tumors within 2 years before the randomization.\n2. Evidence of disease progression within 6 months (before randomization) after completion of prior neoadjuvant or adjuvant chemotherapy (or both) or radiotherapy for gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.\n3. Previous treatment with any HER2-target therapy.\n4. Active gastrointestinal bleeding\n5. Presence of central nervous system (CNS) metastases.\n6. Left ventricular ejection fraction (LVEF) \\\u003C 55%.\n7. Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.",{"count":49,"type":20},550,[23],"This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced\u002Fmetastatic adenocarcinoma of the gastric and\u002For gastroesophageal junction (G\u002FGEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).",[53,54,55,26],"Gastroesophageal-junction Cancer","Monoclonal Antibody","Gastric Cancer","2026-02-24",{"date":58,"type":32},"2026-02-27",{"date":60,"type":32},"2024-11-22",{"date":62,"type":20},"2028-09-01",{"name":64,"class":39},"Shanghai Henlius Biotech",208,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":4},"100618508","phase-2-a-study-of-kn026-based-combination-therapy-in-her2-positive-gastric-cancer-100618508","NCT07332533","A Study of KN026-based Combination Therapy in HER2-positive Gastric Cancer","A Phase II\u002FIII Study of KN026 Combined Chemotherapy With or Without Enlonstobart as First-line Treatment in HER2-positive Unresectable Locally Advanced or Metastatic Gastric Cancer.","Inclusion Criteria:\n\nAge≥18 years old.\n\n* Histologically or cytologically confirmed diagnosis of gastric cancer.\n* Participants unresectable locally advanced or metastatic gastric cancer who had not received systemic treatment (participants who had progressed 6 months after prior neoadjuvant\u002Fadjuvant therapy could be enrolled).\n* Confirmed to be HER2 positive (HER2-positive is defined as IHC 3+ or IHC 2+ with ISH positive) and PD-L1 status (participants of phase III should be confirmed by the pathology department of participating study center).\n* Phase II: Presence of at least 1 measurable lesion per RECIST 1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Phase III:Presence of at least 1 evaluable lesion per RECIST 1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* ECOG PS of 0 - 1.\n* Expected survival ≥ 3 months.\n* Participants with adequate organ functions.\n* Female and male participants of childbearing age agree to take adequate contraceptive measures during and upon completion of the study for 7 months after the last dose. Female participants of childbearing age must have a negative blood pregnancy test within 7 days before randomization.\n* Voluntarily agree to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n* Has received anti-tumor treatment such as systemic chemotherapy or other trial interventions within 28 days, or immunotherapy (e.g. interleukin, interferon, thymospipeptide, etc.), hormone therapy or targeted therapy within 14 days or 5 half-life (whichever is shorter) before randomization.\n* Participants with brain metastasis or spinal cord compression at screening (except for completed local treatment and discontinued glucocorticoids for at least 4 weeks before randomization , and stable central nervous system imaging and brain metastasis symptoms for at least 4 weeks).\n* Participants with PD-L1 CPS ≥1, who are receiving long-term immunotherapy (e.g., cyclosporine) or require daily systemic steroid therapy (e.g., \\>20 mg prednisone or equivalent), except those who treated with local glucocorticoids using nasal spray, inhalation, or other pathways.\n* Participants with PD-L1CPS ≥1, who have an active autoimmune disease or have a history of autoimmune disease 2 years before randomization and still require systemic treatment. However, participant with the following diseases is allowed to enroll: well-controlled type I diabetes, well-controlled hypothyroidism that requires hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss), or participant who is expected to not recur without external triggers.\n* Participate in another clinical trial, unless it is an observational (non-intervention) clinical trial or is in the follow-up period of an intervention trial.\n* Participants who have undergone major surgery or had invasive intervention within 28 days before randomization. Or those who plan to undergo systematic or local tumor resection during the trial .\n* Any Chinese patent medicine with anti-cancer activity approved by the National Drug Administration (regardless of cancer type) has been used within 14 days before randomization.\n* Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.\n* Active bacterial, fungal or viral infection before randomization. Participant who has recieved preventive infection treatment but has no clinical manifestations before randomization could be considered to enroll.\n* Has a history of immunodeficiency, including HIV-positive.\n* Active hepatitis B or C infection. Participant with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) need to test Hepatitis B virus DeoxyriboNucleic Acid (HBV-DNA), and HBV-DNA is higher than 500 IU\u002FmL (or 2500 copies\u002Fml) ; Participants with positive for hepatitis C (HCV) antibody and whose Hepatitis C virus Ribonucleic Acid (HCV-RNA) is higher than 1000 copies\u002Fml or UNL (whichever is lower).\n* Has a history of tuberculosis treatment within 2 years before randomization.\n* Has activity or a history of interstitial lung disease at any stage and\u002For pulmonary function injury, a history of interstitial pneumonia requiring hormone therapy, or the imaging cannot rule out suspected interstitial lung disease\u002Fpneumonia at screening.\n* Known to have low activity or lack of dihydropyrimidine dehydrogenase (DPD).\n* Participants with peripheral neuropathy of grade \\> 1.\n* Participants with clinically significant gastrointestinal diseases including but not limited to severe liver diseases, ulcerative colitis, Crohn's disease and other gastrointestinal diseases 28 days before randomization; Unable to swallow orally, or there are conditions that have been judged by researchers to seriously affect gastrointestinal absorption (such as malabsorption syndrome, etc.).\n* Has a history of severe cardiovascular disease.\n* History of any other malignant tumors within 5 years before randomization.\n* pleural effussion, peritoneal dropsy or pericardial effusion requiring drainage within 2 weeks before randomization.\n* Live vaccination within 28 days before randomization. Note: Seasonal influenza vaccine is a broadly inactivated vaccine and is allowed to be used;\n* Breastfeeding women.\n* Otherwise considered inappropriate for the study by the investigator.",{"count":74,"type":20},490,[76,23],"PHASE2","This study is designed to compare the efficacy and safety of KN026 combined chemotherapy with or without Enlonstobart versus Trastuzumab combined chemotherapy with or without Pembrolizumab as first-line treatment in HER2-positive unresectable locally advanced or metastatic gastric cancer.",[26],"NOT_YET_RECRUITING","2026-01-08",{"date":82,"type":32},"2026-01-12",{"date":84,"type":20},"2025-12-30",{"date":86,"type":20},"2032-12-31",{"name":88,"class":39},"Shanghai JMT-Bio Inc.",{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":116},"100618654","phase-1-fruquintinib-combined-with-trastuzumab-and-xelox-as-first-line-treatment-in-patients-with-her2-positive-advanced-gastric-cancer-100618654","NCT07334431","Fruquintinib Combined With Trastuzumab and XELOX as First-line Treatment in Patients With HER2-positive Advanced Gastric Cancer","Fruquintinib Combined With Trastuzumab and XELOX as First-line Treatment in Patients With HER2-positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: an Open-label, Single-arm, Single-center Phase Ib\u002FII Clinical Study","Inclusion Criteria:\n\n* Have fully understood the study and voluntarily signed the informed consent;\n* 18-75 years old (including 18 and 75 years old);\n* Pathologically determined advanced gastric or gastroesophageal junction adenocarcinoma;\n* No previous anti-tumor treatment for metastatic diseases;\n* HER2 positive;\n* Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;\n* Life expectancy ≥ 3 months;\n* At least one measurable lesion according to RECIST version 1.1;\n* The functions of vital organs met the following requirements (Blood components and cell growth factors were not allowed within 14 days before enrollment):\n\n  * Absolute neutrophil count ≥1.5×109\u002FL;\n  * Platelet ≥100×109 \u002FL;\n  * Hemoglobin ≥90g\u002FL;\n  * Total bilirubin \\\u003C 1.5 ULN;\n  * ALT and\u002For AST \\\u003C 1.5 ULN ;\n  * Serum creatinine (Cr) \\\u003C1.5×ULN;\n  * Endogenous creatinine clearance ≥50ml\u002Fmin;\n* Female patients of childbearing age should take effective contraceptive measures;\n* Good compliance, cooperate with follow-up.\n\nExclusion Criteria:\n\n* Failure to comply with the study protocol or study procedure;\n* Previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors, chemotherapy or immune checkpoint inhibitors;\n* Have had other malignancies within the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;\n* Known presence of symptomatic central nervous system metastasis or brain metastases;\n* Had autoimmune disease or history of autoimmune disease within 4 weeks before enrollment;\n* Previously received allogeneic bone marrow transplantation or organ transplantation;\n* Uncontrolled malignant ascites (defined as ascites that cannot be controlled by diuretics or puncture as determined by the researcher);\n* Severe cardiovascular disease, including unstable angina pectoris or myocardial infarction, occurs within 6 months before the start of study treatment;\n* Subjects who are allergic to the investigational drug or any of its adjuncts;\n* Participated in other domestic unapproved or unmarketed drug clinical trials and accepted the corresponding experimental drug treatment within 4 weeks before enrollment;\n* International Standardized Ratio (INR) \\>1.5 or partially activated prothrombin time (APTT) \\>1.5×ULN;\n* The investigator identified clinically significant electrolyte abnormalities;\n* Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg;\n* Poorly controlled diabetes mellitus was present before enrollment (fasting glucose concentration ≥CTCAE level 2 after formal treatment);\n* Had any disease or condition prior to enrollment that affected drug absorption, or the patient could not take fruquintinib orally;\n* Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unresectosed tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by researchers before enrollment;\n* Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding within 3 months \\>30 mL, hematemesis, stool, stool blood), hemoptysis (within 4 weeks \\>5 mL of fresh blood) or had a thromboembolic event (including stroke events and\u002For transient ischemic attacks) within 12 months;\n* 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; New York Heart Association (NYHA) Grades for Congestive Heart Failure \\>Level 2; Ventricular arrhythmias requiring medical treatment; LVEF (Left ventricular Ejection Fraction) \\\u003C50%;\n* 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; New York Heart Association (NYHA) Grades for Congestive Heart Failure \\>Level 2; Ventricular arrhythmias requiring medical treatment; LVEF (Left ventricular Ejection Fraction) \\>50%;\n* Unmitigated toxicity higher than CTCAE v5.0 grade 1 due to any previous anticancer therapy, excluding alopecia, lymphocytopenia, and oxaliplatin grade ≤2 neurotoxicity;\n* Women who are pregnant (positive pregnancy test before medication) or breastfeeding;\n* Received blood transfusion therapy, blood products and hematopoietic factors, such as albumin and granulocyte colony-stimulating factor (G-CSF), within 14 days before enrollment;\n* 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；\n* Urine routine indicated urinary protein ≥2+, and 24-hour urinary protein volume \\> 1.0g;\n* Complications require long-term treatment with immunosuppressants or systemic or local use of immunosuppressive corticosteroids (\\> 10mg\u002F day prednisone or other therapeutic hormone);\n* Investigators believe that the patient has any other conditions that are not suitable for participating in the study.","75 Years",{"count":98,"type":20},45,[100,76],"PHASE1","This study was designed to evaluate the safety and efficacy of fruquintinib plus trastuzumab, and XELOX as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.",[103,104,105,26,106,107],"Gastric Adenocarcinoma","Gastric (Stomach) Cancer","GEJ Adenocarcinoma","First-line Therapy","Fruquintinib",{"date":82,"type":32},{"date":110,"type":32},"2024-02-22",{"date":112,"type":20},"2026-12-31",{"name":114,"class":115},"Henan Cancer Hospital","OTHER_GOV",1,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":21,"phases":126,"briefSummary":127,"conditions":128,"keywords":133,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":116},"100547957","phase-1-her-2-b-cell-peptide-vaccine-100547957","NCT06414733","HER-2 B Cell Peptide Vaccine","Phase Ib Active Immunotherapy Trial (Expansion) With a Combination of Two Chimeric (Trastuzumab-like and Pertuzumab-like) HER-2 B Cell Peptide Vaccine Emulsified in ISA 720 Adjuvant in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\nInclusion Criteria for Extension and Expansion Cohorts\n\n1. For the extension cohort to be conducted at the IUSCCC (N=12), patients with histologically documented metastatic or unresectable breast or gastrointestinal cancer will be enrolled.\n2. For the expansion cohort (N=30), patients with either histologically documented metastatic or unresectable breast cancer (N=15), or histologically documented metastatic or unresectable gastrointestinal cancer (N=15) be enrolled. All patients enrolled to this cohort are required to have measurable disease. Note: Measurable disease is defined as ≥ 1 lesions that can be accurately measured in ≥ 1 dimensions as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan.\n\n   Inclusion Criteria for all Cohorts:\n3. Patients must have received or refused first line standard systemic therapy for their metastases (if applicable) and patients with histologically confirmed pancreatic and esophageal cancers must have received no more than two prior cytotoxic chemotherapy regimens in the last two years after standard therapy. Patients with histologically confirmed breast, and gastrointestinal cancers must have received no more than three prior cytotoxic chemotherapy regimens in the last two years after standard therapy.\n4. Progressive disease after at least one line of standard therapy.\n5. Patients with pancreatic and esophageal cancers must have received no more than two prior cytotoxic chemotherapy regimens in the last two years. Patients with breast and gastrointestinal cancers must have received no more than three prior cytotoxic chemotherapy regimens in the last two years.\n6. Patients are required to have HER-2 (IHC 1+, 2+ and 3+) or EGFR over-expression (FISH and IHC) to be enrolled on this study.\n\n   1. If the patient has had HER-2 expression measured prior to enrollment, the report alone will be accepted on the expansion phase of the study.\n   2. If the patient has had EGFR expression measured prior to enrollment, the report alone will be accepted on the dose escalation phase of the study.\n   3. If the patient has not had HER-2 or EGFR expression measured prior to enrollment on this study, it would be obligatory for the patient to have the tests performed to justify their status. HER-2 status can be performed by a variety of tests. Either IHC or FISH assay are acceptable if breast tumor tissues (previously frozen) are available. The test can be done at IUSCCC or elsewhere if the patient is from out of town.\n7. Patients with prior history of treated brain metastases who are off steroids and have stable metastatic brain disease for at least 3 months are eligible.\n8. Patients must be ambulatory with an ECOG performance status 0, 1, or 2 (appendix II).\n9. Patients must have adequate organ function as defined by:\n\n   1. ANC ≥ 1,000\u002Fmm³, platelet count \\> 700,000\u002Fmm³.\n   2. Serum bilirubin \\\u003C 1.5 mg%, regardless of whether patients have liver involvement secondary to tumor. ALT must be \\\u003C 2 times upper limit of normal.\n   3. Creatinine \\\u003C1.5 mg\u002Fdl or calculated creatinine clearance \\> 60 ml\u002Fmin\n10. Patients must be at least 3 weeks past any prior surgery, cytotoxic, chemotherapy, other immunotherapy, hormonal therapy, or radiation therapy. Patients having been treated with monoclonal antibodies may enter the trial after a specified period of time (2 times the mean half life of the agent). Patients must have recovered from any toxicity of prior therapy prior to enrolling on study except for neuropathy where patients need to recover to less than grade 2.\n\n    1. Patients with hormone receptor positive breast cancer who are on stable endocrine therapy are eligible if their tumor has some expression of HER-2 based on IHC of 1+ or 2+.\n11. Patients must be at least 18 years of age.\n12. Women of child-bearing potential must not be pregnant and must have a negative pregnancy test (Women of childbearing potential definition: (ECOG definition)).\n13. Men and women must agree to practice effective contraception while on this study.\n14. Patients must obtain a base line Echocardiogram or MUGA and require the left ventricular ejection fraction to be within normal limits (or 50% or higher).\n15. Ability to understand and the willingness to sign a written informed consent document.\n\nThe patient must be aware that his\u002Fher disease is neoplastic in nature and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.\n\nExclusion Criteria:\n\n1. Patients with tumors that are negative for HER-2 expression based on IHC of 0 AND Fluorescence in-situ hybridization showing lack of HER-2 amplification based on most recent ASCO\u002FCAP guidelines; or are under-expressing EGFR based on FISH and IHC.\n2. Patients on targeted therapies, such as Cycline Dependent Kinase (CDK) 4\u002F6 or mammalian target of rapamycin (mTOR) inhibitors in combination with endocrine therapy\n3. Patients who are {MVF-HER-2(266-296) and MVF-HER-2 (597-626)} immediate hypersensitivity skin test positive.\n4. Patients who have evidence of active infection that requires antibiotic therapy. Patients must have been off antibiotic treatment for at least 3 weeks prior to initiating treatment and must be confirmed to be clear of the infection.\n5. Patients with known active HIV, hepatitis A, hepatitis B, or hepatitis C infection.\n6. Patients with serious uncontrolled cardiopulmonary disorders, including congestive heart failure, symptomatic coronary artery disease, serious cardiac arrhythmia, and symptomatic chronic obstructive pulmonary disease or patients with other serious uncontrolled medical diseases. At the discretion of the treating physician, patients who show disease control for at least 6 months may be enrolled.\n7. Patients who require or likely to require corticosteroids or other immunosuppressives for intercurrent disease are NOT eligible.\n8. Splenectomized patients.\n9. Patients with active autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermato-myositis, or a vasculitic syndrome.\n\n   Note: At the discretion of the treating physician, patients who show disease control for at least 6 months may be enrolled.\n10. Patients who have developed anaphylactic responses to other vaccines",{"count":125,"type":20},42,[100],"This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with metastatic solid tumors. Vaccines made from antibodies and peptides combined with tumor cells may help the body build an effective immune response to kill tumor cells.",[129,130,131,26,132],"Metastatic Breast Cancer","Metastatic Gastrointestinal Carcinoma","HER2-positive Breast Cancer","EGFR Overexpression",[134,135,136],"Phase I","Breast Cancer","GI Cancer","2025-08-19",{"date":139,"type":32},"2025-08-24",{"date":141,"type":32},"2025-01-17",{"date":143,"type":20},"2030-12-31",{"name":145,"class":146},"Pravin T.P Kaumaya","OTHER",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":173},"100581183","real-world-effectiveness-and-safety-of-trastuzumab-deruxtecan-in-patients-with-locally-advanced-or-metastatic-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma-in-china-100581183","NCT06846996","Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China","Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China: A Nation-wide, Multi-center, Prospective, Non-interventional Study","RECOVER","Participants must meet all the following inclusion criteria to be eligible for the study:\n\n1. Participants with pathologically diagnosed locally advanced unresectable or metastatic gastric cancer\u002Fgastroesophageal junction adenocarcinoma (GC\u002FGEJA).\n2. ≥18 years of age at the time of starting the first dose of T-DXd and signing informed consent form (ICF), capable of providing informed consent.\n3. HER2-positive status (IHC 3+ or IHC 2+\u002FISH +).\n4. Received prior anti-cancer treatment regimens according to National Medical Products Administration indication or clinical judgement of physician.\n5. Decision to newly initiate T-DXd before study ICF signing. If the participants have started the first dose of T-DXd no longer than 21 days before enrollment, they could be enrolled if the signed and dated ICF could be obtained.\n\nExclusion Criteria：\n\nParticipants who meet any of the following criteria will be excluded from the study:\n\n1. Pregnancy or breastfeeding.\n2. Participants who at the time of data collection of the study are participating in or have participated in an interventional study that remains blinded.\n3. Known hypersensitivity to either the drug substances or inactive ingredients in the drug product.\n4. Judged by the investigator to be unfit to participate in the study.",{"count":156,"type":20},260,"OBSERVATIONAL","Trastuzumab deruxtecan's (T-DXd's) efficacy and safety has been confirmed in traditional clinical trials, there is a lack of real-world evidence, especially among Chinese patients. The objective of this study is to evaluate real-world effectiveness and safety profile of T-DXd by collecting real-world data treating in patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.",[26,160],"HER2-positive Gastroesophageal Junction",[162,163],"HER2-positive gastric cancer","HER2-positive gastroesophageal junction","2025-07-07",{"date":166,"type":32},"2025-07-08",{"date":168,"type":32},"2025-02-27",{"date":170,"type":20},"2027-07-31",{"name":172,"class":39},"Daiichi Sankyo",36,{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":21,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":4},"100592848","phase-2-jskn003-combined-treatment-of-her2-positive-gastric-cancer-100592848","NCT06998771","JSKN003 Combined Treatment of HER2-positive Gastric Cancer","A Phase II Trial to Evaluate the Safety and Efficacy of JSKN003 Combination Therapy as First-line Treatment in HER2-positive Unresectable Locally Advanced or Metastatic Gastric Cancer or Resectable Gastric Cancer","Inclusion Criteria:\n\n* Age≥18 years old.\n* Histologically or cytologically confirmed diagnosis of gastric cancer.\n* The first-line population enrolls participants with HER2-positive unresectable locally advanced or metastatic gastric cancer who had not received systemic treatment, and Perioperative population enrolls participants with HER2-positive resectable gastric cancer who had not received treatment.\n* HER2-positive (defined as IHC3+ or IHC 2+\u002FFISH +).\n* The first-line population: presence of at least 1 measurable lesion per RECIST 1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* ECOG PS of 0 - 1.\n* Expected survival ≥ 3 months.\n* Participants with adequate organ functions.\n* Female and male patients of childbearing age agree to take adequate contraceptive measures during and upon completion of the study for 7 months after the last dose. Female participants of childbearing age must have a negative blood pregnancy test within 7 days before the first dose or randomization.\n* Voluntarily agree to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n* Has received anti-tumor treatment such as systemic chemotherapy or other trial interventions within 28 days, or immunotherapy (e.g. interleukin, interferon, thymospipeptide, etc.), hormone therapy or targeted therapy within 14 days or 5 half-life (whichever is shorter) before the first dose or randomization.\n* Has previously been treated with an anti-HER2 ADC loaded with topoisomerase I inhibitors.\n* Participants with brain metastasis or spinal cord compression at screening (except for completed local treatment and discontinued glucocorticoids for at least 4 weeks before the first dose or randomization , and stable central nervous system imaging and brain metastasis symptoms for at least 4 weeks).\n* Participants with PD-L1 CPS ≥1, who are receiving long-term immunotherapy (e.g., cyclosporine) or require daily systemic steroid therapy (e.g., \\>20 mg prednisone or equivalent), except those who treated with local glucocorticoids using nasal spray, inhalation, or other pathways.\n* Participants with PD-L1CPS ≥1, who have an active autoimmune disease or have a history of autoimmune disease 2 years before the first dose or randomization and still require systemic treatment. However, participant with the following diseases is allowed to enroll: well-controlled type I diabetes, well-controlled hypothyroidism that requires hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss), or participant who is expected to not recur without external triggers.\n* Participate in another clinical trial, unless it is an observational (non-intervention) clinical trial or is in the follow-up period of an intervention trial.\n* Participants who have undergone major surgery or had invasive intervention within 28 days before the first dose or randomization. Or those who plan to undergo systematic or local tumor resection during the trial (Perioperative cohort does not apply).\n* Any Chinese patent medicine with anti-cancer activity approved by the National Drug Administration (regardless of cancer type) has been used within 14 days before the first dose or randomization.\n* Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.\n* Active bacterial, fungal or viral infection before the first dose or randomization. Participant who has recieved preventive infection treatment but has no clinical manifestations before the first dose or randomization could be considered to enroll.\n* Has a history of immunodeficiency, including HIV-positive.\n* Active hepatitis B or C infection. Participant with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) need to test Hepatitis B virus DeoxyriboNucleic Acid (HBV-DNA), and HBV-DNA is higher than 500 IU\u002FmL (or 2500 copies\u002Fml) or upper limit of normal (UNL) (whichever is lower) ; Participants with positive for hepatitis C (HCV) antibody and whose Hepatitis C virus Ribonucleic Acid (HCV-RNA) is higher than 1000 copies\u002Fml or UNL (whichever is lower).\n* Has a history of tuberculosis treatment within 2 years before the first dose or randomization.\n* Has activity or a history of interstitial lung disease at any stage and\u002For pulmonary function injury, a history of interstitial pneumonia requiring hormone therapy, or the imaging cannot rule out suspected interstitial lung disease\u002Fpneumonia at screening.\n* Known to have low activity or lack of dihydropyrimidine dehydrogenase (DPD).\n* Participants with peripheral neuropathy of grade \\> 1.\n* Participants with clinically significant gastrointestinal diseases including but not limited to severe liver diseases, ulcerative colitis, inflammatory bowel disease and other gastrointestinal diseases 28 days before the first dose or randomization.\n* Has a history of severe cardiovascular disease.\n* History of any other malignant tumors within 5 years before the first dose or randomization.\n* Live vaccination within 28 days before the first dose or randomization. Note: Seasonal influenza vaccine is a broadly inactivated vaccine and is allowed to be used;\n* Unable to swallow orally, or there are conditions that have been judged by researchers to seriously affect gastrointestinal absorption (such as severe Crohn's disease, malabsorption syndrome, etc.).\n* Pregnant or breastfeeding women.\n* Otherwise considered inappropriate for the study by the investigator.",{"count":182,"type":20},153,[76],"This study is designed to evaluate the safety and efficacy of JSKN003 combination therapy as first-line treatment in HER2-positive unresectable locally advanced or metastatic gastric cancer or resectable gastric cancer.",[26],"2025-05-22",{"date":188,"type":32},"2025-05-31",{"date":190,"type":20},"2025-06-15",{"date":192,"type":20},"2029-12-31",{"name":88,"class":39},{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":96,"enrollmentInfo":201,"targetDuration":4,"studyType":21,"phases":203,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":217},"100572215","phase-2-first-line-treatment-with-rc48-plus-sintilimab-and-s-1-in-advanced-gastric-cancer-rcts2-100572215","NCT06730373","First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)","A Phase II, Open-Label, Multicenter Trial Comparing Disitamab Vedotin Plus Sintilimab and S-1 With Trastuzumab Plus Chemotherapy ± Sintilimab for First-Line Treatment of HER2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (RCTS2)","Inclusion Criteria:\n\n1. Aged18-75 years, gender is not limited;\n2. Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;\n3. HER2-Positive (IHC3+or IHC2+\u002FFISH+) ;\n4. Has at least 1 measurable lesion as determined by RECIST 1.1;\n5. There is no systematic treatment in the past, or the patient has received neoadjuvant\u002Fadjuvant chemotherapy, but the disease progresses or relapses more than 6 months after the end of treatment;\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n7. Adequate organ function;\n8. The life expectancy is at least 3 months;\n\nExclusion Criteria:\n\n1. Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;\n2. Cardiovascular and cerebrovascular events that are not well controlled;\n3. Has received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks.\n4. Have a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.);\n5. Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases;\n6. Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection.Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment;\n7. Brain metastasis or leptomeningeal metastasis;\n8. Clinically significant pleural effusion, pericardial effusion or ascites should be drained for many times within 2 weeks before the first administration of the trial drug;\n9. Has a second clinically detectable primary malignant tumor at the time of recruitment, or there were other malignant tumors in the past 5 years (except for fully treated skin basal cell carcinoma or cervical carcinoma in situ);\n10. Any major surgery was performed ≤ 28 days before the first trial drug administration;\n11. History of allogeneic stem cell transplantation or organ transplantation;",{"count":202,"type":20},110,[76],"This is a Phase II, randomized, multicenter, open-label clinical trial designed to compare Disitamab Vedotin plus Sintilimab and S-1 with Trastuzumab plus chemotherapy ± Sintilimab for first-line treatment of HER2-Positive advanced gastric or gastroesophageal junction adenocarcinoma.",[26,206,207],"Metastatic Gastric Cancer","Unresectable Gastric Carcinoma","2024-12-29",{"date":210,"type":32},"2024-12-31",{"date":212,"type":32},"2024-10-17",{"date":214,"type":20},"2027-12-31",{"name":216,"class":146},"Qilu Hospital of Shandong University",20,{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":225,"enrollmentInfo":226,"targetDuration":4,"studyType":21,"phases":228,"briefSummary":229,"conditions":230,"keywords":233,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":247},"100494265","phase-2-perioperative-chemotherapy-plus-trastuzumab-plus-toripalimab-in-her2-positive-locally-advanced-gastric-or-esophagogastric-junction-adenocarcinoma-100494265","NCT05715931","Perioperative Chemotherapy Plus Trastuzumab Plus Toripalimab in HER2 Positive Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma","A Multi-center, Phase II Study to Evaluate Efficacy and Safety of Perioperative Chemotherapy With Fluorouracil, Leucovorin, Oxaliplatin, Docetaxel (FLOT) and Trastuzumab in Combination With Toripalimab in Patients With HER2 Positive Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma","Inclusion Criteria:\n\n* Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF).\n* The gender is not limited. Age: ≥ 18 years and ≤ 80 years old.\n* Gastric or esophagogastric junction adenocarcinoma confirmed by pathology.\n* HER2-positive status defined as either IHC score of 3+ or IHC 2+ with amplification proven by fluorescent in situ hybridization (FISH) based on pretreatment endoscopic biopsies.\n* Clinical stage at presentation: cT2-T4b, N+\u002F-, M0 as determined by AJCC staging system, 8th edition.\n\n  * The definition of metastatic lymph nodes: a lymph node must be ≥ 10mm in short axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm) according to the guideline of Response Evaluation Criteria in Solid Tumours (RECIST version 1.1)\n* Participants with a performance status of 0 \\~ 1 on the Eastern Cooperative Oncology Group (ECOG) within 7 days before the first dose of study treatment.\n* Life expectancy ≥ 6 months.\n* Agreement of providing pretreatment endoscopic biopsies specimens and surgical specimens for biomarker analysis, as well as the peripheral blood, feces and urine sample.\n* The functions of the vital organs meet requirements as follow (within 14 days before the first dose of study treatment, participant has not received treatment of recombinant human thrombopoietin or granulocyte stimulating factor):\n\n  1. Hematological function：\n\n     * White blood cell count (WBC): 3.5 × 10 \\^ 9 \u002F L \\~12.0 × 10 \\^ 9 \u002F L；\n     * Absolute neutrophil count (ANC) ≥ 1.5 × 10 \\^ 9 \u002F L；\n     * Platelet count (PLT) ≥ 100 × 10 \\^ 9 \u002F L；\n     * Hemoglobin (Hb) ≥ 90 g \u002F L.\n  2. Hepatic function：\n\n     * Total bilirubin (TBIL) ≤ 1.5 × ULN (upper limit of normal);\n     * Aspartate aminotransferase (AST) ≤ 2.5 × ULN;\n     * Alanine aminotransferase (ALT) ≤ 2.5 × ULN;\n     * Albumin (ALB) ≥ 30 g \u002F L.\n  3. Renal function：\n\n     * Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 60 ml \u002F min for those with creatinine level \\> 1.5 × ULN.\n  4. Coagulation function：\n\n     * International normalized ratio (INR) ≤ 1.5;\n     * Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n  5. Cardiac function:\n\n     * The left ventricular ejection fraction (LVEF) value ≥ 55 %, as assessed by echocardiography\n* Female of childbearing age must meet requirements: urine or serum pregnancy test must be negative within 7 days before the first dose of study treatment, and she must agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of toriplimab, or 210 days after the last dose of trastuzumab, or 180 days after the last dose of chemotherapy, whichever is longer, and should not be breastfeeding. For the male participants must meet requirements: agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of toriplimab, or 210 days after the last dose of trastuzumab, or 180 days after the last dose of chemotherapy, whichever is longer).\n\nExclusion Criteria:\n\n* Prior systemic therapy for treatment of gastric cancer (surgery, chemotherapy, radiotherapy, targeted therapy or immunotherapy).\n* Previous or concurrent have other active malignant tumors within the past 5 years (except for basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate cancer or cervical cancer or breast cancer in situ that has undergone curative therapy).\n* Participants with gastric outlet obstruction, or unable for oral take, or severe gastrointestinal bleeding.\n* Myocardial infarction within 6 months before the first dose of study treatment, uncontrolled angina, arrhythmia which need medical intervention (including but not limited to cardiac pacemaker), congestive heart failure (New York Heart Association (NYHA) class III or IV).\n* Existence of chronic diarrhea (watery diarrhea: ≥ 5 times per day).\n* Participants with active infection within 14 days before the first dose of study treatment which need medical intervention.\n* Participants with active tuberculosis.\n* Previous or concurrent diagnosed with interstitial lung disease by imaging or symptoms.\n* Any of the following test is positive: Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface Antigen (HBsAg), or Hepatitis C Virus (HCV) antibody.\n* Participants who need long-term systemic steroid therapy (\\> 10 mg\u002Fd prednisone equivalent) or any other form of immunosuppressive therapy within 14 days before the first dose of study treatment or during the study period.\n* Concurrent or previous have severe allergic reaction to any antibody-based drugs.\n* Existence of any concurrent autoimmune disease, excepting participants with diabetes mellitus type I, hypothyroidism requiring only hormone replacement therapy.\n* Receive live vaccines within 28 days before the first dose of study treatment or during the study period, excepting inactivated viral vaccines for seasonal influenza.\n* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* Existence of systemic disease that is difficult to control despite treatment with several agents, for example, diabetes mellitus, hypertension, etc.\n* Existence of other serious physical or mental diseases or serious laboratory abnormalities that may increase the risk of participating in the study. Participants who were judged unsuitable as subjects of this trial by investigator.","80 Years",{"count":227,"type":20},30,[76],"This study is a prospective, single arm, multi-center phase II clinical trial designed to evaluate the efficacy and safety of perioperative chemotherapy with FLOT regimen and trastuzumab in combination with toripalimab in participants with resectable HER2 positive locally advanced gastric or esophagogastric junction adenocarcinoma.",[231,232,26],"Adenocarcinoma of the Stomach","Adenocarcinoma of Esophagogastric Junction",[103,234,235,236,237],"Esophagogastric Junction Adenocarcinoma","Perioperative Chemotherapy","Trastuzumab","Toripalimab","2024-09-14",{"date":240,"type":32},"2024-09-19",{"date":242,"type":32},"2023-02-28",{"date":244,"type":20},"2028-03-01",{"name":246,"class":146},"Yu jiren",8,{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":96,"enrollmentInfo":255,"targetDuration":4,"studyType":21,"phases":257,"briefSummary":258,"conditions":259,"keywords":261,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":272,"locationsCount":116},"100560067","phase-1-disitamab-vedotin-plus-trastuzumab-in-patients-with-her2-positive-gcgej-patiens-100560067","NCT06572319","Disitamab Vedotin Plus Trastuzumab in Patients With HER2 Positive GC\u002FGEJ Patiens","Phase I\u002FII Clinical Study of the Combination of Disitamab Vedotin and Trastuzumab in the Treatment of HER2 Positive Gastric\u002FGastroesophageal Junction Tumors With Previous Systemic Therapy Failure","Inclusion Criteria:\n\n1\\. Sign the informed consent form; 2.18-75 years old (including 18 years old, excluding 75 years old), gender not limited; 3. The pathological histology confirmed by pathology is adenocarcinoma of the gastric\u002Fgastroesophageal junction; 4. HER2 positive tumor criteria (primary tumor or metastatic lesion, HER2 positive is defined as IHC 2+\u002FFISH+(HER2: CEP17 ratio ≥ 2.0) or IHC (3+). Using the criteria for interpreting HER2 in gastric cancer 5. Recurrent or metastatic diseases that cannot be surgically treated, with at least one measurable lesion (RECIST 1.1 criteria) in the subject and an estimated survival time of at least 12 weeks; 6. ECOG score ranges from 0 to 1 points; 7. At least first-line systemic therapy has failed (regardless of whether it includes anti-HER2 monoclonal antibody therapy); 8. Having sufficient bone marrow, liver and kidney function:\n\n* Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, platelets ≥ 90 × 109\u002FL, or\n* hemoglobin ≥ 9g\u002FdL;\n* ALT or AST levels without liver metastasis are less than 2.5 times the upper limit of the normal range; When liver metastasis occurs, ALT or AST is less than 5 times the upper limit of the normal range; Serum bilirubin is 1.5 times lower than the upper limit of the normal reference range;\n* Serum creatinine is lower than 1.5 times the upper limit of the normal reference range or creatinine clearance rate is ≥ 40ml\u002Fmin; 9. Women of childbearing age and their spouses are willing to use effective contraceptive methods within the last 7 months of treatment.\n\nExclusion Criteria:\n\n1. Known to be allergic to the received therapeutic drugs or excipients;\n2. Baseline LVEF\\\u003C50% (measured by echocardiography or MUGA);\n3. Previously received treatment with anti-HER2 ADC drugs;\n4. Individuals who have undergone systemic immunotherapy, biologic therapy, or participated in any clinical drug trials within the past 2 weeks;\n5. Those who have undergone surgery within 3 weeks before the start of the experimental treatment and have not fully recovered;\n6. Patients with uncontrolled central nervous system (CNS) metastases or epilepsy requiring medication treatment;\n7. Serious systemic diseases. Such as infected or uncontrolled diabetes;\n8. Suffering from other malignant tumors within 5 years, except for non melanoma skin cancer and cervical carcinoma in situ;\n9. Clinically symptomatic active coronary heart disease, cardiomyopathy, or congestive heart failure, NYHA III-IV; uncontrolled hypertension (systolic blood pressure\\>180 mmHg or diastolic blood pressure\\>100 mmHg), clinically symptomatic heart valve disease, or high-risk arrhythmia;\n10. Patients receiving long-term or high-dose corticosteroid treatment (inhaled steroids or short-term oral steroids are allowed to resist vomiting or promote appetite)\n11. Individuals without legal capacity, those whose medical or ethical reasons affect the continuation of research;\n12. Pregnant and lactating female patients, or those who wish to become pregnant during treatment;\n13. Uncontrolled pleural and peritoneal effusion;\n14. There is a persistent infection of\\>level 2 (CTC-AE 4.0); Wounds, ulcers, or fractures that cannot heal, or patients with a history of organ transplantation;\n15. There are unresolved toxicity levels\\>1 caused by any previous treatment\u002Fprocedure (CTC-AE 4.0, excluding hair loss, anemia, and hypothyroidism);\n16. After comprehensive assessment of the patient's condition by the researchers, it is deemed that they are not suitable to participate in this study;\n17. Simultaneously participating in another clinical study.",{"count":256,"type":20},35,[100,76],"This trial is a single center, single arm, open label clinical study aimed at evaluating the efficacy and safety of the combination therapy of Disitamab Vedotin and trastuzumab in the treatment of advanced HER-2 positive gastric\u002Fgastroesophageal junction tumors",[26,260],"HER2-positive Gastroesophageal Junction Adenocarcinoma",[262,263,264,265],"HER-2","ADC","Disitamab Vedotin","trastuzumab","2024-08-23",{"date":268,"type":32},"2024-08-27",{"date":270,"type":20},"2024-09-01",{"date":112,"type":20},{"name":273,"class":146},"Zhejiang Cancer Hospital",{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":21,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":116},"100553917","phase-2-rc48-plus-ak104-as-first-line-treatment-for-her2-overexpressing-advanced-gastric-cancer-100553917","NCT06492317","RC48 Plus AK104 as First-line Treatment for HER2-overexpressing Advanced Gastric Cancer","A Prospective, Single-center, Phase II Clinical Study of First-line Treatment for HER2 (Human Epidermal Growth Factor Receptor 2) Overexpressing Advanced Gastric Cancer With Disitamab Vedotin in Combination With Cadonilimab","Inclusion Criteria:\n\n1. Age: more than 18 years, gender is not limited;\n2. Confirmed locally advanced or distant metastasis gastric or gastroesophageal junction adenocarcinoma that is inoperable by pathological examination;\n3. Confirmed HER2 2+or 3+ by immunohistochemistry (IHC);\n4. At least 1 measurable lesion as determined by RECIST 1.1;\n5. There is no prior systematic treatment, or the patient has received neoadjuvant\u002Fadjuvant chemotherapy, and the disease progresses or relapses more than 6 months after the treatment;\n6. Eastern Cooperative Oncology Group (ECOG)performance status of 0-1;\n7. Adequate organ function:\n\n   1. Bone marrow function: Hemoglobin count (HGB)≥80g\u002FL;\n   2. Neutrophil count (NE)≥1.5×109\u002FL;\n   3. White blood cell count (WBC)≥3.5×109\u002FL;\n   4. Platelet count (PLT)≥100×109\u002FL；\n   5. Liver function: i. Serum total bilirubin (TBIL)≤1.5×ULN; ii. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP)≤3×ULN, patients with liver metastasis≤5×ULN;\n   6. Kidney function: Blood creatinine (Cr) ≤1.5×ULN or Cockcroft Gault formula ≥ 60 mL\u002Fmin;\n   7. Cardiac function: New York Heart Association (NYHA) classification\\\u003CGrade 3; Left ventricular ejection fraction≥50%;\n8. At least 3 months life expectancy ;\n9. The female of childbearing age must have taken reliable contraceptive measures or conducted a negative pregnancy test (serum or urine) within 7 days before enrollment, and are willing to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the test drug; the male must agree to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the trial;\n10. Willing to join the study and signed an informed consent form (ICF) with good compliance and cooperation in follow-up.\n\nExclusion Criteria:\n\n1. Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drugs;\n2. Uncontrollable cardiovascular and cerebrovascular events , such as:\n\n   1. NYHA grade 2 or above heart failure;\n   2. Unstable angina pectoris;\n   3. Myocardial infarction occurred within 12 months;\n   4. Supraventricular or ventricular arrhythmia with clinical significance needs treatment or intervention;\n   5. Cerebral hemorrhage and cerebral infarction (except for lacunar cerebral infarction without symptoms and without treatment);\n   6. Serious cardiovascular and cerebrovascular events occurred within 12 months; Uncontrolled hypertension, i.e. systolic blood pressure\\>140 mmHg or diastolic blood pressure\\>90 mmHg after treatment;\n   7. A history of arterial thrombosis or deep vein thrombosis within 6 months , or with evidence of bleeding tendency or medical history within 2 months, regardless of the severity;\n   8. Stroke event or transient ischemic attack occurred within 12 months.\n3. Received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks;\n4. A history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.);\n5. A history of active immune deficiency or autoimmune diseases, including HIV positive, or others acquired or congenital immune deficiency diseases, or organ transplantation;\n6. Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection. A history of active tuberculosis infection ≥ 1 year should also be excluded, unless proved has been completed appropriate treatment;\n7. Brain metastasis or leptomeningeal metastasis;\n8. Clinically significant pleural effusion, pericardial effusion or ascites should be drained for many times within 2 weeks before the first administration of the drugs;\n9. Another clinically detectable primary malignant tumor at the time of recruitment, or other malignant tumors in the past 5 years (except for fully treated skin basal cell carcinoma or cervical carcinoma in situ);\n10. Any major surgery was performed ≤ 28 days before the drugs administration;\n11. History of allogeneic stem cell transplantation or organ transplantation;\n12. Be suffering gastrointestinal diseases: uodenal ulcer, ulcerative colitis, intestinal obstruction and others at present; or other conditions that may cause gastrointestinal bleeding or perforation judged by the researchers; or history of intestinal perforation or fistula, but has not recovered after surgical treatment;\n13. Live vaccine are inoculated within 4 weeks (inclusive) before the first administration of the drugs, not including seasonal influenza vaccines but intranasal vaccine;\n14. Other factors may lead to the forced termination of this trial according to the judgment of the investigator, such as other serious diseases (including psychological and mental diseases) requiring combined treatment, serious laboratory examination abnormalities, and family or social factors, which may affect the safety of the subject, or the collection of data and samples;\n15. Participating in other therapeutic clinical studies or using research instruments within 4 weeks before the first administration;\n16. Others conditions do not meet the inclusion according to the judgment of the investigator.",{"count":217,"type":20},[76],"A single-arm, single-center phase II trial study to assess the efficacy and safety of disitamab vedotin plus cadonilimab as first-line therapy for HER2-overexpressing advanced stomach carcinoma",[26],"2024-07-08",{"date":287,"type":32},"2024-07-09",{"date":289,"type":20},"2024-07-06",{"date":291,"type":20},"2027-07-06",{"name":293,"class":146},"The First Affiliated Hospital of Zhengzhou University",{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":21,"phases":304,"briefSummary":305,"conditions":306,"keywords":307,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":317,"locationsCount":116},"100535578","phase-2-adjuvant-trastuzumab-deruxtecan-for-her2-positive-gastroesophageal-cancer-with-persistence-of-minimal-residual-disease-100535578","NCT06253650","Adjuvant TRastuzumab Deruxtecan for HER2-positive Gastroesophageal Cancer With Persistence of miNImal Residual Disease","Adjuvant TRastuzumab Deruxtecan Plus Fluoropyrimidine Versus Standard Chemotherapy In HER2-positive Gastric or Gastroesophageal Cancer Patients With Persistence of miNImal Residual Disease in Liquid Biopsy After Pre-operative chemoTherapy and Radical surgerY","TRINITY","Inclusion Criteria of the Interventional TRINITY study:\n\n1. Written informed consent and any locally required authorization (such as the European Union \\[EU\\] Data Privacy Directive) obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations.\n2. Compliance with all the study procedures and treatments. Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating Centre.\n3. Age ≥ 18 years old.\n4. Eastern Cooperative Oncology group (ECOG) Performance Status 0-1.\n5. Life expectancy of at least 12 weeks.\n6. Resected gastric or gastroesophageal junction (Siewert I-II-III) cancer\u002Fesophageal adenocarcinoma, after the completion of pre-operative chemotherapy with FLOT, as per standard clinical practice.\n7. Absence of distant metastases as defined by post-operative radiological assessments (contrast-enhanced CT scan of the thorax and abdomen or, in case of contraindications, non-contrast-enhanced chest CT scan and abdomen Magnetic Resonance Imaging)\n8. Presence of locally determined HER2 overexpression\u002Famplification on the post-treatment surgical tissue specimen defined as IHC 3+ or 2+\u002FISH amplified.\n9. Positivity of the post-operative liquid biopsy, performed 2-6 weeks after the radical surgery.\n10. LVEF ≥ 50% within 28 days before randomization\u002Fenrolment.\n11. Adequate bone marrow and organ function within 14 days before randomization\u002Fenrolment as described below:\n\n    1. Neutrophil count ≥ 1.5 x 10\\^3\u002FμL\n    2. Platelet count ≥ 100 x 10\\^6\u002FμL\n    3. Haemoglobin ≥ 9 g\u002FdL\n    4. Total bilirubin lower than 1.5 time the upper-normal limits (ULN) of the Institutional normal values\n    5. AST (SGOT) and\u002For ALT (SGPT) \\\u003C3 x ULN\n    6. serum albumin ≥ 2.5 g\u002FdL\n    7. Creatinine clearance (calculated according to Cockroft and Gault) \\> 60 mL\u002Fmin\n    8. International normalised ratio or Prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 × ULN\n12. Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner. For women of childbearing potential, a negative result for serum pregnancy test (test must have a sensitivity of at least 25 mIU\u002FmL) must be available at the screening visit and urine beta-human chorionic gonadotropin (β-HCG) pregnancy test prior to each administration of IMP. Women of childbearing potential are defined as those who are not surgically sterile (i.e. underwent bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.\n13. Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, from the time of screening and must agree to continue using such precautions for 7 months after the last dose of IMP. Not all methods of contraception are highly effective. Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of IMP. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable.\n14. Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening to 4 months after the final dose of IMP for T-DXd while 6 months for docetaxel and oxaliplatin. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is in line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable. It is strongly recommended for the female partners of a male patient to also use at least one highly effective method of contraception throughout this period. In addition, male patients should refrain from fathering a child, or freezing or donating sperm from the time of randomisation\u002Fenrolment, throughout the study and for 4 months after the last dose of IMP for T-DXd while 6 months for docetaxel and oxaliplatin. Preservation of sperm should be considered prior to enrollment in this study.\n15. Female subjects must not donate, or retrieve for their own use, ova from the time of randomization\u002Fenrolmentand throughout the study treatment period, and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to enrollment in this study.\n\nExclusion Criteria of the Interventional TRINITY study:\n\n1. Involvement in the planning and\u002For conduct of the study (applies to both Investigator staff and\u002For staff at the study site)\n2. Participation in another clinical study with an investigational product during the last 12 months\n3. Signs of distant metastases at any site.\n4. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, renal disease, neurological disease or peripheral neuropathy, serious chronic gastrointestinal conditions associated with diarrhea, or substance abuse or any other medical or psychiatric illness\u002Fsocial situations that in the opinion of the investigator would limit compliance with study requirement, interfere with the subject's participation in the clinical study, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent or interfere with the evaluation of the clinical study results.\n5. Patients with a medical history of myocardial infarction (MI) within 6 months before randomization\u002Fenrolment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), Subjects with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation before enrollment to rule out MI.\n6. Corrected QT interval (QTcF) prolongation to \\> 470 msec (females) or \\>450 msec (males) based on average of the screening triplicate12-lead ECG.\n7. History of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening.\n8. Lung criteria:\n\n   * Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g. pulmonary emboli within three months of the study enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion etc.)\n   * Any autoimmune, connective tissue or inflammatory disorders (e.g. Rheumatoid arthritis, Sjogren's, sarcoidosis etc.) where there is documented, or a suspicion of pulmonary involvement at the time of screening. Full details of the disorder should be recorded in the eCRF for patients who are included in the study.\n   * Prior pneumonectomy (complete)\n9. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals\n10. Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection not under adequate disease control (that is defined as the presence of all the following conditions: receiving stable regimen of highly active anti-retroviral therapy for at least 4 weeks prior to study enrollment, CD4+ count above 250 cells\u002FμL, undetectable viral load on standard polymerase chain reaction-based tests, absence of any HIV-related opportunistic infections for at least 4 weeks prior to study enrollment and no requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections), or active hepatitis B or C infection (HBsAg, anti-HBs, anti-HBc, anti-HCV). Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients who are anti-HBc positive and HBsAg negative or patients with HBsAg positive have to dose HBV-DNA. If HBV DNA is undetectable (\\\u003C10UL\u002Fml or under the limit of detection per local lab standard) are considered as HBV negative. Subjects should be tested for HIV prior to randomization\u002Fenrollment if required by local regulations or institutional review board (IRB)\u002Fethics committee (EC).\n11. Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of T-DXd. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IMP.\n12. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to \\>Grade 2 for at least 3 months prior to \\[randomization\u002Fenrollment\u002FCycle 1 Day 1\\] and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, such as: chemotherapy-induced neuropathy and fatigue.\n13. Known allergy or hypersensitivity to study treatment or any of the study drug excipients.\n14. History of severe hypersensitivity reactions to other monoclonal antibodies.\n15. Pregnant or breastfeeding female patients, or patients who are planning to become pregnant.\n16. Multiple primary malignancies within 3 years, except for\n\n    * adequately resected non-melanoma skin cancer\n    * curatively treated in-situ disease\n    * other solid tumors curatively treated\n17. A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).\n18. LVEF\\\u003C 50% within 28 days before enrolment.\n19. Prior treatment with an anti-HER2 agent.\n20. Absence of locally determined HER2 overexpression\u002Famplification on the surgical specimen defined as IHC 0 or 1+ or 2+\u002FISH not amplified.\n21. Negativity of ctDNA at the post-operative liquid biopsy.\n\n21\\. Known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency based on local laboratory testing before the start of pre-operative FLOT regimen. Confirmation of the assessment of DPD status before the start of pre-operative FLOT in the patient's records should be provided before the enrollment in the interventional study.",{"count":303,"type":20},46,[76],"TRINITY is designed as a multicentre, randomized, open-label, interventional phase II study aimed at investigating the activity, efficacy and safety of trastuzumab-deruxtecan (T-DXd) plus capecitabine\u002F5-fluorouracil as a post-operative treatment in localized\u002Flocally advanced gastric or gastroesophageal junction cancer (GC\u002FGEJC)\u002Fesophageal adenocarcinoma patients with HER2 overexpression\u002Famplification and positive post-operative ctDNA after pre-operative 5-fluorouracil plus leucovorin, oxaliplatin, and docetaxel (FLOT) regimen followed by radical surgery.",[55,26],[308,55,26,309,310],"Trastuzumab-Deruxtecan","Liquid biopsy","Minimal residual disease","2024-06-12",{"date":313,"type":32},"2024-06-13",{"date":315,"type":32},"2024-03-01",{"date":244,"type":20},{"name":318,"class":146},"Gruppo Oncologico del Nord-Ovest",{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":96,"enrollmentInfo":326,"targetDuration":4,"studyType":21,"phases":327,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":336,"locationsCount":4},"100549860","phase-2-adjuvant-treatment-with-serplulimabtrastuzumab-and-sox-in-the-her-2-positive-gcgejc-100549860","NCT06439550","Adjuvant Treatment With Serplulimab，Trastuzumab and SOX in the HER-2 Positive GC\u002FGEJC","Adjuvant Treatment With Serplulimab，Trastuzumab and SOX in the of HER-2 Positive Gastric\u002FGastroesophageal Junction Carcinoma (GC\u002FGEJC)","Inclusion Criteria:\n\n1. Histologically confirmed gastric adenocarcinoma\u002Fesophagogastric junction adenocarcinoma, HER-3 + or HER-2 +, with Fish amplification;\n2. Subjects must complete R0 resection before enrollment；If they received neoadjuvant therapy, it was required that the neoadjuvant therapy regimen should not contain anti-HER-2 targeted drugs;\n3. Postoperative pathology: II-III;\n4. Age 18-75 years old;\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;\n6. Blood routine and biochemistry within 7 days before enrollment : a. Hemoglobin ≥90g\u002FL; Absolute neutrophil count (ANC) ≥1.5×109\u002FL; Platelets ≥100×109\u002FL (no blood transfusion within 14 days before treatment, no granulocyte colony-stimulating factor, no correction with other drugs); b. ALT and AST≤2.5 times the normal upper limit (ULN); ALP≤2.5 times ULN; c. Serum total bilirubin \\\u003C1.5 ULN (Gilbert syndrome patients with total bilirubin \\\u003C3 ULN can be enrolled); d. Serum creatinine \\\u003C1.5 ULN or estimated glomerular filtration rate ≥60ml\u002Fmin\u002F1.73m2; e. Serum albumin ≥30g\u002FL; f. International Normalized Ratio (INR) or prothrombin time (PT) ≤1.5 times ULN, unless the patient is receiving anticoagulant therapy and the PT value is within the intended treatment range of the anticoagulant; g. Activated partial thromboplastin time (APTT) ≤1.5 times ULN.\n7. No serious concomitant diseases that make the survival time less than 5 years;\n8. Voluntary and able to adhere to the program during the study;\n9. Provide written informed consent form before entering the study, and the subjects has understood that he can withdraw from the study at any time during the study without any loss.\n\nExclusion Criteria:\n\n1. A history of any other malignancy in the past 5 years (except carcinoma in situ or basal cell carcinoma of the skin or squamous cell carcinoma of the skin)；Patients with small gastric stromal tumors and other tumors may be excluded if the researcher determines that other tumors will not affect the patient's life in the short term；\n2. Participated in clinical trials of other drugs within four weeks;\n3. Have any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; subjects has vitiligo; asthma that has completely relieved in childhood and does not require any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included)\n4. Requires systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration to treat a current condition.\n5. Any active malignant tumour within 2 years, excluding the specific cancer being studied in this trial and the locally recurrent cancer that has been cured (such as basal cell or squamous cell skin cancer that has been removed, superficial bladder cancer cancer, cervical or breast cancer in situ);\n6. Subjects with central nervous system metastasis or a history of central nervous system metastasis. With clinically suspected CNS metastasis, CT or MRI must be performed within 28 days before starting treatment to rule out CNS metastasis；\n7. With unstable angina pectoris; Newly diagnosed angina pectoris within 3 months prior to screening or myocardial infarction events occurred within 6 months prior to screening; Arrhythmias (including QTcF: ≥ 450 ms for males and ≥ 470 ms for females) require long-term use of antiarrhythmic drugs and a New York Heart Association grade of ≥ II cardiac dysfunction;\n8. Or urinary protein qualitative ≥2+, 24 hours urinary protein \\> 1g\n9. For female subjects: should be surgically sterilized, postmenopausal, or consent to use a medically approved contraceptive during the study treatment period and for 6 months after the end of the study treatment period; Serum or urine pregnancy tests must be negative within 7 days before enrollment and must be non-lactating. Male subjects: patients who should be surgically sterilized or who have consented to use a medically approved contraceptive method during the study treatment period and for 6 months after the end of the study treatment period;\n10. Liver transplantation patients；\n11. With infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other subjects require the use of corticosteroids;\n12. Have a history of chronic autoimmune diseases, such as systemic lupus erythematosus;\n13. Have a history of inflammatory bowel diseases such as ulcerative colitis and Crohn's disease, and a history of chronic diarrhea diseases such as irritable bowel syndrome；\n14. Have a history of sarcoidosis or tuberculosis；\n15. With active HBV, HCV，and HIV infection；\n16. Subjects with a history of psychotropic substance abuse and are unable to abstain or have mental disorders; 17) Thoracic or abdominal effusion with clinical symptoms that require clinical intervention; 18) A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 19) According to the judgment of the researcher,there is a serious concomitant disease that endangers the patient's safety or interferes with the patient's completion of the study.",{"count":125,"type":20},[76],"This is a prospective, single arm, multicenter phase II study to assess the effectiveness of Serplulimab，Trastuzumab and SOX in the adjuvant treatment of HER-2 Positive Gastric\u002FGastroesophageal Junction Carcinoma (GC\u002FGEJC)",[26],"2024-05-28",{"date":332,"type":32},"2024-06-03",{"date":334,"type":20},"2024-07-15",{"date":112,"type":20},{"name":293,"class":146},"HER2 Positive Gastric Cancer"]