Status:
UNKNOWN
HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer
Lead Sponsor:
Taizhou Hanzhong biomedical co. LTD
Conditions:
Stomach Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 10 2023
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT04486651
Start Date
September 16 2020
End Date
August 10 2023
Last Update
January 28 2021
Active Locations (64)
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1
Anhui Provincial Cancer Hospital
Hefei, Anhui, China, 230000
2
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
3
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
4
Beijing ChaoYang Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100020