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

Description

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).

Conditions

Gastroesophageal-junction Cancer, Monoclonal Antibody, Gastric Cancer, HER2-positive Gastric Cancer

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Study Overview

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Study Details

Study 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).

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

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

Condition
Gastroesophageal-junction Cancer
Intervention / Treatment

-

Contacts and Locations

Anaheim

Los Angeles Cancer Network, Anaheim, California, United States, 92801

Los Alamitos

OPN - Oncology Physician Network (Los Alamitos), Los Alamitos, California, United States, 90720

Brooksville

Access Research Institute, Brooksville, Florida, United States, 34613

Deerfield Beach

Advanced Research LLC, Deerfield Beach, Florida, United States, 33064

Plantation

BRCR Medical Center, Plantation, Florida, United States, 33322

Pompano Beach

Napa Research, Pompano Beach, Florida, United States, 33064

Saint Louis

Washington University School of Medicine St. Louis, Saint Louis, Missouri, United States, 63110

Omaha

Nebraska Cancer Specialists, Omaha, Nebraska, United States, 68130

Las Vegas

Comprehensive Cancer Centers Nevada, Las Vegas, Nevada, United States, 89169

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male/female who are at least 18 years of age on the day of signing the informed consent.
  • 2. With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
  • 3. Had measurable disease as assessed by IRRC according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
  • 4. 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.
  • 5. ECOG PS within 7 days before randomization: 0-1.
  • 6. Expected survival ≥ 6 months.
  • 7. Had adequate organ function
  • 1. Patients with other malignant tumors within 2 years before the randomization.
  • 2. 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.
  • 3. Previous treatment with any HER2-target therapy.
  • 4. Active gastrointestinal bleeding
  • 5. Presence of central nervous system (CNS) metastases.
  • 6. Left ventricular ejection fraction (LVEF) \< 55%.
  • 7. Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Shanghai Henlius Biotech,

Study Record Dates

2028-09-01