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

Inclusion Criteria:

1. Male/female who are at least 18 years of age on the day of signing the informedconsent.

2. With histologically or cytologically confirmed diagnosis of previously untreated,locally advanced unresectable or metastatic HER2-positive gastric orgastroesophageal junction adenocarcinoma.

3. Had measurable disease as assessed by IRRC according to the RECIST v1.1, the targetlesion must not be a bone metastatic lesion only.

4. HER2-positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH+ orFISH, 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) aftercompletion of prior neoadjuvant or adjuvant chemotherapy (or both) or radiotherapyfor 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 anycomponent of study treatment.