Clinical trial · Interventional
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
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
NCT07669740CI-TRIAL-00115837not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer (Diagnosis) | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sintilimab Combined with Ramucirumab and Paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A Study on the Efficacy and Safety of Sintilimab Combined with Ramucirumab and Paclitaxel in the Tre
- description
- 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
- interventionNames
- Drug: Sintilimab Combined with Ramucirumab and Paclitaxel
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- From baseline until disease progression or study completion, assessed up to 24 months
- description
- Proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1.
Secondary outcomes (1)
- measure
- Progression-Free Survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.