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A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
NCT06532006 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06532006
The ClinicalTrials.gov registry entry for NCT06532006 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 550 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shanghai Henlius Biotech, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06532006 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06532006?
The interventions under investigation include: Pembrolizumab (DRUG), Trastuzumab (DRUG), Capecitabine (DRUG), Oxaliplatin (DRUG), HLX22 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06532006?
This trial is sponsored by Shanghai Henlius Biotech, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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