About this trial
To explore the efficacy and safety of sintilimab combined with ramucirumab and paclitaxel in the treatment of advanced gastric cancer patients with short-term recurrence after postoperative adjuvant therapy, and to identify efficacy-related biomarkers to guide subsequent individualized treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Active malignancy within the past 5 years, except for adequately treated in situ carcinoma or other cancers with a negligible risk of recurrence.
Prior participation in another investigational drug study within 4 weeks prior to enrollment.
Symptomatic central nervous system (CNS) metastases.
Active autoimmune disease requiring systemic treatment.
Trial design
Single group
Treatments tested in this trial
Sintilimab Combined with Ramucirumab and Paclitaxel
DrugSintilimab Combined with Ramucirumab and Paclitaxel in the Treatment of Gastric Cancer Patients with Short-term Recurrence after Adjuvant Therapy
Treatment groups
Trial outcomes
Primary outcomes
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1.
Secondary outcomes
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from baseline to the first documented disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.
Sponsors and contacts
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