Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Dietary Supplement: Taurine
* Biological: Sintilimab
* Drug: XELOX regimen
* Drug: SOX regimen
* Drug: FOLFOX regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older, no gender limitation; Pathologically confirmed gastric cancer or adenocarcinoma of the gastroesophageal junction, local lesions cannot be radically resected or metastatic gastric cancer; Expected survival of ≥ 3 months; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; At least one measurable lesion outside the stomach (RECIST 1.1); Patients informed about the purpose and course of the study and provided a written consent to participate. Exclusion Criteria: Use of taurine agent within 1 month prior to randomization on this study; Patients received prior systemic therapy for gastric cancer; Patients with operable gastric cancer; Patients with positive HER-2 and willing to receive herceptin treatment; Patients with gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia; Patients with active autoimmune disease that has required systemic treatment in past 2 years; Patients diagnosed as immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy; Patients with severe heart, lung, liver, kidney, endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group; Patients with other medical conditions that interfere with the trial and are deemed unsuitable for inclusion in the trial by the investigator; Other conditions that the investigator thinks are not suitable to participate in this clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Taurine + Sintilimab + investigator's choice chemotherapy<br>Taurine + Sintilimab + XELOX or Taurine + Sintilimab + SOX or Taurine + Sintilimab + FOLFOX | Dietary Supplement: Taurine<br>* Taurine supplementation in capsules of 1.0 gram of taurine powder. Dosage: 2.0 gram/day. Frequency: 2 time/day.<br>Biological: Sintilimab<br>* Sintilimab<br>Drug: XELOX regimen<br>* Oxaliplatin + capecitabine<br>Drug: SOX regimen<br>* Oxaliplatin + S-1 (tegafur/gimeracil/oteracil potassium)<br>Drug: FOLFOX regimen<br>* Oxaliplatin + leucovorin + fluorouracil<br>|
| Active Comparator: Sintilimab + investigator's choice chemotherapy<br>Sintilimab + XELOX or Sintilimab + SOX or Sintilimab + FOLFOX | Biological: Sintilimab<br>* Sintilimab<br>Drug: XELOX regimen<br>* Oxaliplatin + capecitabine<br>Drug: SOX regimen<br>* Oxaliplatin + S-1 (tegafur/gimeracil/oteracil potassium)<br>Drug: FOLFOX regimen<br>* Oxaliplatin + leucovorin + fluorouracil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | 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. | Up to 24 months | 
| Overall survival (OS) | OS was defined as the time from randomization to death due to any cause. | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) according to RECIST 1.1 criteria. | Up to 24 months | 
| Safety profile | Number of study subjects experiencing adverse events (AEs), dose-limiting toxicities, and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations. | Up to 24 months |