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
Updated on 3 February 2021
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 IdentifierNCT04486651
SponsorTaizhou Hanzhong biomedical co. LTD
Last Modified on3 February 2021

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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