[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602769":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":52,"collaborators":54,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":26,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":26,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":26,"overallStatus":79,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Peking University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental arm","EXPERIMENTAL","iparomlimab and tuvonralimab",[13],"Drug: Iparomlimab and Tuvonralimab",{"label":15,"type":16,"description":17,"interventionNames":18},"Control arm","ACTIVE_COMPARATOR","standard first-line chemotherapy（FOLFOX\u002FXELOX\u002FSOX） combined with PD-1\u002FPD-L1 antibody",[19],"Drug: First line chemotherapy plus PD-1\u002FPD-L1 antibody",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Iparomlimab and Tuvonralimab","Iparomlimab and tuvonralimab for experimental arm",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"First line chemotherapy plus PD-1\u002FPD-L1 antibody","standard first-line chemotherapy（FOLFOX\u002FXELOX\u002FSOX）combined with PD-1\u002FPD-L1 antibody for control arm",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Lin Shen","CONTACT","（86）10-88196561","linshenpku@163.com",[38],{"facility":39,"status":26,"city":40,"state":26,"zip":26,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Department of GI Oncology, Peking University Cancer Hospital","Beijing","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50],{"name":33,"role":34,"phone":51,"phoneExt":26,"email":36},"(86)10-88196561",{"type":53,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[55,57],{"name":56,"class":6},"Peking University Cancer Hospital & Institute",{"name":58,"class":59},"Qilu Pharmaceutical Group Co., Ltd","UNKNOWN","100602769","phase-2-assessing-iparomlimab-and-tuvonralimab-in-recurrent-or-metastatic-msi-hdmmr-gastric-cancer-100602769",false,"NCT07127822","Assessing Iparomlimab and Tuvonralimab in Recurrent or Metastatic MSI-H\u002FdMMR Gastric Cancer","A Randomized, Controlled, Non Inferiority Phase II Clinical Study Comparing Iparomlimab and Tuvonralimab With Standard Chemotherapy Combined With PD-1\u002FPD-L1 Monoclonal Antibody as First-line Treatment for MSI-H\u002FdMMR Recurrent\u002FMetastatic Gastric Cancer","Inclusion Criteria:\n\n1\\. Voluntarily willing to participate in the study and sign the written informed consent form 2. Age ≥18 years male or female . 3. Expected survival time ≥ 3 months 4. Patients with unresectable locally advanced, recurrent, or metastatic gastric\u002Fgastroesophageal junction adenocarcinoma diagnosed by histological or cytological examination: 5. Confirmed by PCR or next-generation sequencing(NGS) as microsatellite instability-high(MSI-H) . Patients with mismatch repair defecient identified by immunohistochemistry need to undergo PCR\u002FNGS verification as MSI-H before treatment 6. Patients should not receive systematic anti-tumor treatment before, and for those who have received induction chemotherapy, concurrent radiochemotherapy, or neoadjuvant\u002Fadjuvant chemotherapy for curative purposes, the recurrence time must be at least 6 months from the end of the last treatment; 7. Agree to provide archived tumor tissue specimens or fresh tissue samples of primary or metastatic lesions within 3 years; If the patinet is unable to provide tumor tissue samples, they can be enrolled after evaluation by the researcher, provided that they meet other inclusion and exclusion criteria; 8. Patients must have at least one measurable lesion defined by RECIST 1.1. 9. European Cooperative Oncology Group (ECOG) ≤1 10. No severe cardiac dysfunction, left ventricular ejection fraction ≥ 50%; 11. Patients must meet the following criteria at screening and before preconditioning (baseline). If any laboratory test result is abnormal referring to the following criteria,\n\n1. Hematology: neutrophils (NE) ≥1.5×109 per liter, , platelets (PLT) ≥100×109per liter and hemoglobin (Hb) ≥8.0 g\u002FdL.\n2. Blood chemistry: creatinine clearance ≥50 mL\u002Fmin, Creatinine (Cr) ≤ 1.5 × ULN, alanine aminotransferase (ALT) ≤2.5×ULN（Gilbert syndrome or liver metastasis subjects ≤ 5 × ULN）, aspartate aminotransferase (AST) ≤2.5×ULN（Gilbert syndrome or liver metastasis subjects ≤ 5 × ULN）, total bilirubin (TB) ≤1.5×ULN（Gilbert syndrome or liver metastasis subjects ≤ 3 × ULN）,\n3. International normalized ratio (INR) ≤ 1.5, and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 12. Urinary protein ≤ 2+or \\\u003C 1000mg\u002F24h; 13. Women of childbearing potential must have negative serum pregnancy test result at screening and before preconditioning and agree to use an effective and reliable contraceptive method for at least 1 year after the last study treatment. Te acceptable methods include bilateral tubal ligation\u002Fbilateral salpingectomy or bilateral tubal occlusion; any approved oral, injection or implantation of hormone; or barrier contraceptive method: condoms containing spermicidal .\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Previous use of PD-1\u002FPD-L1 monoclonal antibodies, CTLA-4 monoclonal antibodies, or monoclonal and bispecific drugs containing the aforementioned targets;\n3. Existence of any active autoimmune disease or history of autoimmune disease (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; asthma in which subjects require bronchodilators for medical intervention cannot be included); However, the following diseases are allowed to be included: vitiligo, psoriasis, alopecia without systemic treatment, well controlled type I diabetes, hypothyroidism with normal thyroid function after replacement treatment;\n4. Patients who require immunosuppressive therapy, systemic or absorbable local hormone therapy to achieve immunosuppressive goals (calculated as prednisone, dose\\>10mg\u002Fday or other therapeutic hormones) and continue to use it within 2 weeks of the first administration;\n5. Patients with uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage;\n6. Patients with uncontrollable symptoms of brain metastasis, spinal cord compression, malignant meningitis, or brain or pia mater diseases detected by CT or MRI examination during screening within 4 weeks before the first administration\n7. Patients who have received non systematic anti-tumor therapy within 3 weeks prior to the start of treatment, including but not limited to surgery, radiation therapy, interventional therapy, and anti-tumor traditional Chinese medicine treatment (based on the indications in the Chinese medicine instructions, and may also be enrolled after a 2-week washout period). Patients whose adverse events caused by previous treatment (excluding hair loss) have not recovered to ≤ CTCAE grade 2 are not within the above range;\n8. Patients with any severe and\u002For uncontrolled illnesses, including:\n\n1\\) Patients with poor blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg) 2) Patients who experience unstable angina, myocardial infarction, ≥ grade 2 congestive heart failure, or arrhythmia requiring treatment within 6 months of initial administration (including QTc ≥ 480ms); 3) Active or uncontrolled severe infection (≥ CTCAE grade 2 infection); 4) A history of clinically significant liver disease, including viral hepatitis, known as a carrier of hepatitis B virus (HBV), must exclude active HBV infection, i.e. HBV DNA positive (\\>2000 IU\u002FmL); Known hepatitis C virus infection (HCV) and HCV RNA positivity (\\>1 × 103 copies\u002FmL), or other decompensated liver diseases or chronic hepatitis requiring antiviral therapy; 5) HIV test positive 6) Poor control of diabetes (fasting blood glucose ≥ CTCAE level 2); 9. Patients who have experienced severe infections (CTCAE\\>grade 2) within the first 4 weeks of randomization, such as severe pneumonia, bacteremia, sepsis, tuberculosis, etc; Indications of pulmonary infection or active pulmonary inflammation within the first 2 weeks of randomization; 10. Patients with a history of allergies to recombinant humanized antibodies who are allergic to any excipient components of the drug; 11. History of autologous or allogeneic stem cell transplantation; 12. Patients with a history of serious neurological or psychiatric disorders, including but not limited to: dementia, depression, epileptic seizures, bipolar disorder, etc; 13. Patients diagnosed as active malignant tumor within the first 3 years of randomization, except for the following cases: radical skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ and\u002For radical resection of carcinoma in situ, which the researchers think can be included; 14. Patients who plan to receive live vaccines within 28 days prior to randomization; 15. Researchers evaluate situations where participation in this clinical trial is inappropriate due to complications or other reasons.","ALL","18 Years",{"count":70,"type":71},106,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","A randomized controlled phase II study exploring first-line treatment options for recurrent\u002Fmetastatic MSI-H gastric cancer",[77,78],"Gastric \u002F Gastroesophageal Junction Adenocarcinoma","MSI-H Cancer","NOT_YET_RECRUITING","2025-08-15",{"date":82,"type":83},"2025-08-17","ACTUAL",{"date":85,"type":71},"2025-09-01",{"date":87,"type":71},"2028-12-31",{"name":5,"class":6},1]