hx008 plus irinotecan versus placebo plus irinotecan as second-line treatment in advanced gastric cancer

Conditions: Stomach Cancer

Summary: this is a randomized, double-blinded, multicenter study to evaluate the efficacy and safety of hx008 injection combined with irinotecan versus placebo combined with irinotecan as second-line therapy in patients with adcanced gastric or gastroesophageal junction (gej) adenocarcinoma who have had tumor progression after first-line treatment with platinum and/or fluropyrimidine therapy.


Eligibility criteria:
inclusion criteria: * understood and signed an informed consent form. * age ≥ 18 and ≤ 75 years old, male or female. * has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma of stomach or the esophagogastric junction (gej). * has experienced documented objective radiographic or clinical disease progression during or after first-line therapy containing platinum and/or fluoropyrimidine therapy. * willing to provide tissue for pd-l1 biomarker analysis. * has a performance status of 0 or 1 on the eastern cooperative oncology group (ecog) performance score. * life expectancy ≥ 3 months. * has adequate organ function. * female participants of childbearing potential should have a negative pregnancy within 72 hours before the randomization. male and female participants should agree to use an adequate method of contraception during the experiment and 1 year after the last administration of the test drugs. exclusion criteria: * has squamous cell or undifferentiated gastric cancer. * diagnosed additional maliganancy within 3 years prior to randomization with the expection of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervival or non-muscle invasive bladder cancers. * has had a prior anti-cancer monoclonal antibody within 4 weeks prior to the first dose of trial treatment or who has not recovered (≤ grade 1 or at baseline) from aes due to agents administered more than 4 weeks earlier. * has had prior chemotherapy,radiation therapy or targeted small molecular therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (≤ grade 1 or at baseline) from aes due to a previously administrated agent. * has received prior therapy with an anti-pd-1, or anti-pd-l1, or anti-ctla-4 agents. * has known active central nervous system (cns) metastases and/or carcinomatous meningitis. * has uncontrolled ascites, pleural effusion, or pericardial effusion. * has active autoimmune disease that has required systemic treatment in past 2 years. * has received a major surgery within 4 weeks prior to randomization. * has received system treatment with corticosteroids (dose \>10mg/day prednison or other therapeutic hormones) within 2 weeks prior to the first dose of trial treatment. * has incomplete intestinal obstruction, active gastrointestinal hemorrhage and perforation. * has a history of non-infectious pneumonitis that required steriods or has current pneumonitis. * has any serious and/or uncontrolled disease. * has active viral infection. * has received a live vaccine within 30 days prior to the first dose of trial treatment. * has participated in other anticancer drug clinical trials within 4 weeks. * according to the judgement of the investigators, there are other factors that may lead to the termination of the study.