Clinical trial · Interventional
Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer
A Prospective, Randomized Controlled Clinical Study of The Efficacy and Safety of Taurine Combined With Sintilimab and Chemotherapy Versus Sintilimab Combined With Chemotherapy for Treatment of Advanced Gastric Cancer
- 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)
This project aims to evaluate the efficacy and safety of oral taurine supplementation combined with PD-1 inhibitor (sintilimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with sintilimab and chemotherapy alone.
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 | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFOX regimen | Drug | FOLFOX Regimen | ALIAS |
| Sintilimab | Biological | Sintilimab | ALIAS |
| SOX regimen | Drug | — | UNRESOLVED |
| Taurine | Dietary Supplement | — | UNRESOLVED |
| XELOX regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Taurine + Sintilimab + investigator's choice chemotherapy
- description
- Taurine + Sintilimab + XELOX or Taurine + Sintilimab + SOX or Taurine + Sintilimab + FOLFOX
- interventionNames
- Dietary Supplement: Taurine
- Biological: Sintilimab
- Drug: XELOX regimen
- Drug: SOX regimen
- Drug: FOLFOX regimen
- type
- ACTIVE_COMPARATOR
- label
- Sintilimab + investigator's choice chemotherapy
- description
- Sintilimab + XELOX or Sintilimab + SOX or Sintilimab + FOLFOX
- interventionNames
- Biological: Sintilimab
- Drug: XELOX regimen
- Drug: SOX regimen
- Drug: FOLFOX regimen
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 or older, no gender limitation; 2. Pathologically confirmed gastric cancer or adenocarcinoma of the gastroesophageal junction, local lesions cannot be radically resected or metastatic gastric cancer; 3. Expected survival of ≥ 3 months; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 5. At least one measurable lesion outside the stomach (RECIST 1.1); 6. Patients informed about the purpose and course of the study and provided a written consent to participate. Exclusion Criteria: 1. Use of taurine agent within 1 month prior to randomization on this study; 2. Patients received prior systemic therapy for gastric cancer; 3. Patients with operable gastric cancer; 4. Patients with positive HER-2 and willing to receive herceptin treatment; 5. Patients with gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia; 6. Patients with active autoimmune disease that has required systemic treatment in past 2 years; 7. Patients diagnosed as immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy; 8. Patients with severe heart, lung, liver, kidney, endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group; 9. Patients with other medical conditions that interfere with the trial and are deemed unsuitable for inclusion in the trial by the investigator; 10. Other conditions that the investigator thinks are not suitable to participate in this clinical trial.
References
Publications (0)
Data not yet available