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ACTIVE NOT RECRUITING
NCT04908813
PHASE2

Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer

Sponsor: Shanghai Henlius Biotech

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the clinical efficacy and safety of HLX22 in the HER2+ Locally Adanved or Metastatic Gastric Cancer as the first-line therapy.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria. The enrolled subjects will receive an intravenous infusion of HLX22/placebo and SOC(standard of care: Trastuzumab + XELOX) once every 3 weeks until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent or other reasons as specified in the protocol(whichever occurs earlier).

Official title: A Randomized, Double-blinded,Multicenter,Phase II Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Placebo in Combination With Trastuzumab and Chemotherapy (XELOX) for Treatment of Locally Advanced or Metastatic Gastric Cancer (GC)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2021-09-29

Completion Date

2025-12

Last Updated

2024-04-15

Healthy Volunteers

No

Conditions

Interventions

DRUG

HLX22

IV Q3W D1

DRUG

Placebo

IV Q3W D1

DRUG

Trastuzumab

IV Q3W D1

DRUG

Oxaliplatin

IV Q3W D1

DRUG

Capecitabine

PO Q3W D1-D14

Locations (1)

Shanghai East Hospital

Shanghai, China