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NCT06532006 · ClinicalTrials.gov registry record · Phase 3
A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
A Phase 3 study of Gastric Cancer and Gastroesophageal-junction Cancer, sponsored by Shanghai Henlius Biotech.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 550
- Enrollment target
- 20
- Study locations
NCT06532006: Recruiting Phase 3 study of Gastric Cancer and Gastroesophageal-junction Cancer, sponsored by Shanghai Henlius Biotech.
NCT06532006 is a Phase 3 study of Gastric Cancer and Gastroesophageal-junction Cancer that is actively recruiting participants, run by Shanghai Henlius Biotech. The registered enrollment target is 550 participants, above the 316-participant average among 153 other Gastric Cancer trials with a reported enrollment target (74% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06532006, a Phase 3 study of Gastric Cancer and Gastroesophageal-junction Cancer, is actively recruiting participants, sponsored by Shanghai Henlius Biotech.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 550 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Trastuzumab
- DRUG Capecitabine
- DRUG Oxaliplatin
- DRUG HLX22
Study Locations (20)
Florida
- 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
- Florida Cancer Specialist - East - West Palm Beach
California
- Los Angeles Cancer Network - Anaheim
- OPN - Oncology Physician Network (Los Alamitos) - Los Alamitos
Illinois
- Northwestern University - Chicago
- University of Chicago - Chicago
Iowa
- Mission Cancer + Blood (Exigent Network) - Des Moines
- Holden Comprehensive Cancer Center - University of Iowa - Iowa City
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
- Guthrie Medical Group, PC and Robert Packer Hospital (Guthrie Cancer Center - Sayre) - Sayre
Colorado
- Banner MD Anderson Cancer Center - Greeley
Missouri
- Washington University School of Medicine St. Louis - St Louis
Nebraska
- Nebraska Cancer Specialists - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 2024-11-22 |
| Est. Completion | 2028-09-01 |
| Phase | Phase 3 |
What NCT06532006 shows while recruiting
NCT06532006 is an interventional study that assigns participants to a tested intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap, above the 316-participant average among 153 other Gastric Cancer trials with a reported enrollment target (74% higher).
The record links to 4 conditions, with Gastric Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT06532006 names 20 study sites across 11 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT06532006 about?
NCT06532006 is a clinical study titled "A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer". 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 ...
What is the current status of trial NCT06532006?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 550 participants. The study started on 2024-11-22. Estimated completion is 2028-09-01.
What conditions does trial NCT06532006 study?
This clinical trial studies the following conditions: Gastric Cancer, Gastroesophageal-junction Cancer, HER2-positive Gastric Cancer, Monoclonal Antibody.
What interventions are being tested in trial NCT06532006?
The interventions under investigation include: Pembrolizumab (DRUG), Trastuzumab (DRUG), Capecitabine (DRUG), Oxaliplatin (DRUG), HLX22 (DRUG).
Who is sponsoring clinical trial NCT06532006?
This trial is sponsored by Shanghai Henlius Biotech, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06532006 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gastric Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06532006's enrollment target sits among peer trials
550 19th of 153 higher than 135 of 153 other Gastric Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastric Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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