NCT06532006 A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
| NCT ID | NCT06532006 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Shanghai Henlius Biotech |
| Condition | Gastroesophageal-junction Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 550 participants |
| Start Date | 2024-11-22 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 550 participants in total. It began in 2024-11-22 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion 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 Exclusion Criteria: 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06532006 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastroesophageal-junction Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06532006 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 550 participants.
Is NCT06532006 currently recruiting?
Yes, NCT06532006 is actively recruiting participants. Contact the research team at ying_li1@henlius.com for enrollment information.
Where is the NCT06532006 trial being conducted?
This trial is being conducted at Anaheim, United States, Los Alamitos, United States, Greeley, United States, Deerfield Beach, United States and 11 additional locations.
Who is sponsoring the NCT06532006 clinical trial?
NCT06532006 is sponsored by Shanghai Henlius Biotech. The trial plans to enroll 550 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.