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

Sponsor
Taizhou Hanzhong biomedical co. LTD
Study ID
NCT04486651
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan Hydrochloride Injection — DRUG
    160 mg/m² administered as IV infusion on Day 1 of each 14-day cycle.
  • HX008 — DRUG
    200 mg administered as IV infusion on Day 1 of each 21-day cycle.
  • Placebo — DRUG
    Administered as IV infusion on Day 1 of each 21-day cycle.

Study Details

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.

Key Dates

Start date
Sep 16, 2020
Status verified
Jan 2021
Primary completion
Aug 10, 2023
Completion
Aug 10, 2023

Study Design

Enrollment
560 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HX008 plus Irinotecan
    Participants recieve HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.
  • Placebo Comparator: Placebo plus Irinotecan
    Participants recieve placebo intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.

Primary Outcome Measure

Overall Survival (OS) in All Participants [ Time Frame: Up to approximately 36 months ]

Central Contacts

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