Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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).
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 550 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 316-participant average among 153 other Gastric Cancer trials with a reported enrollment target (74% higher). The listed sponsor is Shanghai Henlius Biotech, which has 8 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
-
AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2
RECRUITING · Phase 3
-
Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
RECRUITING · Phase 3
-
Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2
RECRUITING · Phase 3
-
Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
ACTIVE NOT RECRUITING · Phase 3
-
Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.
ACTIVE NOT RECRUITING · Phase 3
-
Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers
COMPLETED · Phase 3
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.