HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer

STATUS

Recruiting
End date

Aug 10, 2023
participants needed

560
sponsor

Taizhou Hanzhong biomedical co. LTD

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Updated on 3 February 2021

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gastric adenocarcinoma

metastatic adenocarcinoma

fluoropyrimidine

irinotecan

adenocarcinoma

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.

Details

Condition	Gastropathy, Stomach Discomfort, Gastric Cancer, Gastric Cancer, Stomach Cancer, Stomach Discomfort, Gastric Carcinoma, Stomach Cancer, gastric cancers
Treatment	Placebo, Irinotecan Hydrochloride Injection, HX008
Clinical Study Identifier	NCT04486651
Sponsor	Taizhou Hanzhong biomedical co. LTD
Last Modified on	3 February 2021

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Eligibility		Yes	No	Not Sure
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

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HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer