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
The First Affiliated Hospital with Nanjing Medical University
Phase
Phase 2
Started
2026-07-01
Last updated
2026-06-25
Condition(s) studied
Gastric Cancer (Diagnosis)
Investigational drug(s) / intervention(s)
Sintilimab Combined with Ramucirumab and Paclitaxel
Sintilimab Combined with Ramucirumab and Paclitaxel: Sintilimab Combined with Ramucirumab and Paclitaxel in the Treatment of Gastric Cancer Patients with Short-term Recurrence after Adjuvant Therapy
Study summary
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
Sex
ALL
Min age
15 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Objective Response Rate (ORR) — From baseline until disease progression or study completion, assessed up to 24 months Proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Nanjing Medical University
Nanjing
Jiangsu
More The First Affiliated Hospital with Nanjing Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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