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

Starting soon · Phase 2

Conditions studied: Gastric Cancer (Diagnosis)

In brief

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.

Key facts

Study ID

NCT07669740

Run by

The First Affiliated Hospital with Nanjing Medical University

People needed

30

Starts

2026-07-01

Expected to finish

2028-12-30

Last updated by the study team

2026-06-25

Who can join

Age: 15 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Uncontrolled cardiovascular disease or uncontrolled hypertension.
• History of thromboembolic events or clinically significant bleeding disorders within 6 months prior to enrollment.
• Active tuberculosis or interstitial lung disease.
• Known hypersensitivity to monoclonal antibodies or any excipients of the study drug.

Where it is running

• The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China

Full record on ClinicalTrials.gov

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