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

106 Participants
are divided into 2 treatment groups

Locations

1
Department of GI Oncology, Peking University Cancer Hospital Beijing China

Sponsors and collaborators

Peking University

Lead sponsor

Peking University Cancer Hospital & Institute

Collaborator

Qilu Pharmaceutical Group Co., Ltd

Collaborator