Recruiting NCT06532006

A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer

Phase III Interventional Gastroesophageal-junction Cancer Monoclonal Antibody Gastric Cancer HER2-positive Gastric Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: HLX22, Pembrolizumab, Trastuzumab, Oxaliplatin.
Who it may be relevant to: Registry conditions: Gastroesophageal-junction Cancer, Monoclonal Antibody, Gastric Cancer, HER2-positive Gastric Cancer. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Brazil, Chile +12
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-blinded, Multicenter, Phase Ⅲ Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Trastuzumab and Chemotherapy (XELOX) With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer

Overview

This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).

Detailed description

In experimental group: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) ± placebo (for pembrolizumab), once every 3 weeks (Q3W).

In control group: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) ± pembrolizumab, Q3W.

Interventions

Drug HLX22
HLX22 15mg/kg Q3w
Drug Pembrolizumab
Pembrolizumab 200mg q3w
Drug Trastuzumab
Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance thereafter ,Q3W
Drug Oxaliplatin
Oxaliplatin 130 mg/m2 ,Q3W
Drug Capecitabine
Capecitabine 1000 mg/m2 bid on Days 1-14 ,Q3W

Primary outcome measures

Progression-Free Survival (PFS)per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee) [Time frame: Up to 5 years]
Overall Survival （OS） [Time frame: Up to 5 years]

Secondary outcome measures (3)

PFS per RECIST 1.1 assessed by investigator [Time frame: Up to 5 years]
Objective Response Rate (ORR) assessed by IRRC and investigator per RECIST v1.1 [Time frame: Up to 5 years]
Adverse events (AE) [Time frame: Up to 5 years]

Eligibility criteria

Inclusion criteria

Male/female who are at least 18 years of age on the day of signing the informed consent.
With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
Had measurable disease as assessed by IRRC according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
HER2-positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH+ or FISH, as assessed by a central laboratory on a primary or metastatic tumor.
ECOG PS within 7 days before randomization: 0-1.
Expected survival ≥ 6 months.
Had adequate organ function

Exclusion criteria

Patients with other malignant tumors within 2 years before the randomization.
Evidence of disease progression within 6 months (before randomization) after completion of prior neoadjuvant or adjuvant chemotherapy (or both) or radiotherapy for gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
Previous treatment with any HER2-target therapy.
Active gastrointestinal bleeding
Presence of central nervous system (CNS) metastases.
Left ventricular ejection fraction (LVEF) < 55%.
Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

China · 48 centers

Affiliated Hospital of Youjiang Medical University for Nationalities — Baise City
Beijing Cancer Hospital — Beijing
Cancer Hospital Chinese Academy of Medical Sciences — Beijing
Peking Union Medical College Hospital — Beijing
The First Affiliated Hospital of Bengbu Medical University — Bengbu
The First Hospital of Jilin University — Changchun
Hunan Cancer Hospital — Changsha
Heping Hospital Affiliated to Changzhi Medical College — Changzhi
… and 40 more centers

United States · 29 centers

Los Angeles Cancer Network — Anaheim
OPN - Oncology Physician Network (Los Alamitos) — Los Alamitos
Banner MD Anderson Cancer Center — Greeley
Advanced Research LLC — Deerfield Beach
Florida Cancer Specialist - South — Fort Myers
BRCR Medical Center — Plantation
Napa Research — Pompano Beach
Florida Cancer Specialist - North — St. Petersburg
… and 21 more centers

Japan · 26 centers