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

NCT04486651 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2021-01-28

No results posted yet for this study

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.

Conditions

  • Stomach Cancer

Interventions

DRUG

Irinotecan Hydrochloride Injection

160 mg/m² administered as IV infusion on Day 1 of each 14-day cycle.

DRUG

HX008

200 mg administered as IV infusion on Day 1 of each 21-day cycle.

DRUG

Placebo

Administered as IV infusion on Day 1 of each 21-day cycle.

Sponsors & Collaborators

  • Taizhou Hanzhong biomedical co. LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2023-08-10
Completion
2023-08-10

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04486651 on ClinicalTrials.gov