---
title: Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer
nct_id: NCT06123455
overall_status: UNKNOWN
phase: PHASE2
sponsor: Tang-Du Hospital
study_type: INTERVENTIONAL
primary_condition: Gastric Cancer
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06123455.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06123455"
ct_last_update_post_date: 2023-11-08
last_seen_at: "2026-05-12T07:32:24.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer

**Official Title:** 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

**NCT ID:** [NCT06123455](https://clinicaltrials.gov/study/NCT06123455)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Tang-Du Hospital
- **Conditions:** Gastric Cancer
- **Start Date:** 2023-08-01
- **Completion Date:** 2025-07-31
- **CT.gov Last Update:** 2023-11-08

## Brief Summary

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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Taurine + Sintilimab + investigator's choice chemotherapy** (EXPERIMENTAL) — Taurine + Sintilimab + XELOX or Taurine + Sintilimab + SOX or Taurine + Sintilimab + FOLFOX
- **Sintilimab + investigator's choice chemotherapy** (ACTIVE_COMPARATOR) — Sintilimab + XELOX or Sintilimab + SOX or Sintilimab + FOLFOX

## Interventions

- **Taurine** (DIETARY_SUPPLEMENT) — Taurine supplementation in capsules of 1.0 gram of taurine powder. Dosage: 2.0 gram/day. Frequency: 2 time/day.
- **Sintilimab** (BIOLOGICAL) — Sintilimab
- **XELOX regimen** (DRUG) — Oxaliplatin + capecitabine
- **SOX regimen** (DRUG) — Oxaliplatin + S-1 (tegafur/gimeracil/oteracil potassium)
- **FOLFOX regimen** (DRUG) — Oxaliplatin + leucovorin + fluorouracil

## Primary Outcomes

- **Progression-free survival (PFS)** _(time frame: Up to 24 months)_ — PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on independent radiology review or death due to any cause, whichever occurs first.
- **Overall survival (OS)** _(time frame: Up to 24 months)_ — OS was defined as the time from randomization to death due to any cause.

## Secondary Outcomes

- **Objective response rate (ORR)** _(time frame: Up to 24 months)_
- **Safety profile** _(time frame: Up to 24 months)_

## Locations (1)

- Tang-Du Hospital, Xi'an, Shaanxi, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.tang-du hospital|xi'an|shaanxi|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06123455.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06123455*  
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