ASKB589 in Combination With CAPOX and Sintilimab in Patients With Advanced, and Unresectable G/GEJ Cancer.
Gastric Cancer
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria: Histopathologically confirmed unresectable locally advanced, recurrent, or metastatic adenocarcinoma of the gastric and gastroesophageal junction currently ineligible for surgery and radical radiotherapy. Investigators determined that the present situation of the patient justifies chemotherapy plus immunotherapy as first-line treatment. Tumor tissue samples are CLDN18.2 positive detected by central laboratory ECOG performance status 0-1. The results of the laboratory tests must meet all criteria Life expectancy of at least 3 months. Exclusion Criteria: Known active central nervous system metastasis or suspected cancerous meningitis; There are moderate to large amounts of abdominal and pleural fluid. The presence of clinically uncontrollable third interspace fluid; Patients with any other malignant tumors within the past 5 years. Applicable to anti-HER-2 drug therapy; Anti-CLDN18.2 antibody, anti-PD-1 antibody, or drug therapy at any time in the past; Patients have received antitumor therapy during the first 4 weeks before study drug use; Pregnant or lactating women; or women of childbearing age who have a positive blood pregnancy test during screening period; or women of childbearing age and their spouses who are unwilling to take effective contraceptive measures during the period of this clinical trial and within 6 months after the end of the clinical trial;
Sites / Locations
- Beijing Cancer HospitalRecruiting
Arms of the Study
Arm 1
Experimental
ASKB589 +CAPOX+Sintilimab
Oxaliplatin: intravenous infusion, 130mg/m2, infusion for more than 3h, every 3 weeks for a cycle, infusion 6 cycles; Capecitabine: oral administration, 1000mg/m2, 2 times, 14 days, 7 days rest, every 3 weeks for a cycle; Sintilimab was administered intravenously at 200mg. The drug was administered once every 3 weeks, and the longest cumulative duration was 2 years. ASKB589 is administered intravenously at a fixed dose. the drug was given once every 3 weeks for a cycle, with the longest cumulative duration of 2 years.