About this trial
A randomized controlled phase II study exploring first-line treatment options for recurrent/metastatic MSI-H gastric cancer
Eligibility criteria
Qualifiers
None
Disqualifiers
Hematology: neutrophils (NE) ≥1.5×109 per liter, , platelets (PLT) ≥100×109per liter and hemoglobin (Hb) ≥8.0 g/dL.
Blood chemistry: creatinine clearance ≥50 mL/min, 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),
International normalized ratio (INR) ≤ 1.5, and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 12. Urinary protein ≤ 2+or < 1000mg/24h; 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/bilateral salpingectomy or bilateral tubal occlusion; any approved oral, injection or implantation of hormone; or barrier contraceptive method: condoms containing spermicidal .
Pregnant or lactating women.
Trial design
Treatments tested in this trial
- Iparomlimab and Tuvonralimab
- First line chemotherapy plus PD-1/PD-L1 antibody
Treatment groups
Sponsors and collaborators
Peking University
Lead sponsor
Peking University Cancer Hospital & Institute
Collaborator
Qilu Pharmaceutical Group Co., Ltd
Collaborator