A Trial of SHR1701 Plus Chemotherapy in Patients With Gastric or Gastroesophageal Cancer

Inclusion Criteria:

1. Pathologically confirmed diagnosis of locally advanced unresectable or metastaticgastric or gastroesophageal junction (GEJ)adenocarcinoma.

2. HER2 overexpression or amplification negative.

3. Female or male, 18 years of age or above.

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.

5. Patients who are willing and able to provide the signed informed consent form,willing and able to comply with all the scheduled visits, study treatment,laboratory tests, and other study procedures.

Exclusion Criteria:

1. Squamous cell carcinoma, undifferentiated carcinoma, or other histological types ofgastric cancer.

2. Presence of inadequately treated CNS metastases, or uncontrolled or symptomaticactive CNS metastases ，leptomeningeal disease, and/or rapid progression.

3. Presence of uncontrolled pleural effusion or ascites despite puncture drainagewithin 14 days prior to randomization.

4. More than 20% weight loss within 2 months prior to randomization.

5. Diagnosed with other malignant tumors within 5 years prior to enrollment.

6. Presence of any active, known or suspected autoimmune disease.

7. Prior treatment with TGF-β inhibitor, anti-PD-1/PD-L1 antibodies, anti-PD-L2antibodies, anti-CD137 antibodies, anti-CTLA-4 antibodies, or otherdrugs/antibodies.

8. Severe, unhealed, or dehisced wounds and active ulcers or untreated fractures.