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

Source: https://onco.cc/trials/nct06532006/  
OnCo record `nct06532006` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing HLX22 in gastric & gastro-oesophageal junction cancer, now recruiting.

## Summary

A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer is a phase 3 interventional study registered as NCT06532006, led by Shanghai Henlius Biotech with Henlius USA, and recruiting on the registry. Official title: A Randomised, 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. Planned enrolment is 550 participants (estimated). The study started in 2024-11-22 and primary completion is expected in 2027-06-01. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-11
- Tags: ctgov-ingest
- Registry id: NCT06532006
- Phase: 3
- Setting: 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
- Sponsor: Shanghai Henlius Biotech
- Enrolled: 550

## Sources

- ClinicalTrials.gov NCT06532006: https://clinicaltrials.gov/study/NCT06532006

## Connected records

- cancers: [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [HER2-positive gastric cancer](https://onco.cc/cancers/gastric-her2-positive/)
- drugs: [HLX22](https://onco.cc/drugs/hlx22/)
- companies: [Shanghai Henlius Biotech](https://onco.cc/companies/henlius/)

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