A Study on the Efficacy and Safety of Sintilimab Combined With Ramucirumab and Paclitaxel in the Treatment of Gastric Cancer Patients With Short-term Recurrence After Adjuvant Therapy

Prior treatment

• Prior participation in another investigational drug study within 4 weeks prior to enrollment.
• History of thromboembolic events or clinically significant bleeding disorders within 6 months prior to enrollment.

Other illness

• Active malignancy within the past 5 years, except for adequately treated in situ carcinoma or other cancers with a negligible risk of recurrence.
• Active autoimmune disease requiring systemic treatment.
• Uncontrolled cardiovascular disease or uncontrolled hypertension.
• Active tuberculosis or interstitial lung disease.
• Known hypersensitivity to monoclonal antibodies or any excipients of the study drug.

Other

• Symptomatic central nervous system (CNS) metastases.

• Age ≥18 years at the time of informed consent.
• Histologically confirmed gastric or gastroesophageal junction (GEJ)adenocarcinoma.
• HER2-negative disease, as determined by standard testing methods.
• Prior D2 radical gastrectomy with R0 resection.
• Disease recurrence during adjuvant chemotherapy or within 6 months after completion of adjuvant chemotherapy.
• At least one measurable lesion according to RECIST version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Adequate organ and bone marrow function.
• Life expectancy of at least 3 months.
• Ability to understand and willingness to sign written informed consent.