Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Taurine + Sintilimab + investigator's choice chemotherapy Taurine + Sintilimab + XELOX or Taurine + Sintilimab + SOX or Taurine + Sintilimab + FOLFOX |
Dietary Supplement: Taurine
Taurine supplementation in capsules of 1.0 gram of taurine powder. Dosage: 2.0 gram/day. Frequency: 2 time/day.
Biological: Sintilimab
Sintilimab
Drug: XELOX regimen
Oxaliplatin + capecitabine
Drug: SOX regimen
Oxaliplatin + S-1 (tegafur/gimeracil/oteracil potassium)
Drug: FOLFOX regimen
Oxaliplatin + leucovorin + fluorouracil
|
| Active Comparator: Sintilimab + investigator's choice chemotherapy Sintilimab + XELOX or Sintilimab + SOX or Sintilimab + FOLFOX |
Biological: Sintilimab
Sintilimab
Drug: XELOX regimen
Oxaliplatin + capecitabine
Drug: SOX regimen
Oxaliplatin + S-1 (tegafur/gimeracil/oteracil potassium)
Drug: FOLFOX regimen
Oxaliplatin + leucovorin + fluorouracil
|
Outcome Measures
Primary Outcome Measures
- Progression-free survival (PFS) [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) [Up to 24 months]
OS was defined as the time from randomization to death due to any cause.
Secondary Outcome Measures
- Objective response rate (ORR) [Up to 24 months]
ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.
- Safety profile [Up to 24 months]
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.
Other Outcome Measures
- Changes in CD8+ T cell death and function [Up to 24 months]
Changes in number, apoptosis rate, effector (TNF-α, IFN-γ, etc.) production and immune checkpoint molecule (PD-1, CTLA-4, etc.) expression of CD8+ T cells in peripheral venous blood assessed via flow cytometry.
- Changes in CD8+ T cell infiltration in tumor tissue [Up to 24 months]
Changes in number, effector (TNF-α, IFN-γ, etc.) production and immune checkpoint molecule (PD-1, CTLA-4, etc.) expression of tumor-infiltrating CD8+ T cells in gastric cancer endoscopic biopsy material assessed via immunohistochemistry.
Eligibility Criteria
Criteria
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:
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Use of taurine agent within 1 month prior to randomization on this study;
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Patients received prior systemic therapy for gastric cancer;
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Patients with operable gastric cancer;
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Patients with positive HER-2 and willing to receive herceptin treatment;
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Patients with gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia;
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Patients with active autoimmune disease that has required systemic treatment in past 2 years;
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Patients diagnosed as immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy;
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Patients with severe heart, lung, liver, kidney, endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group;
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Patients with other medical conditions that interfere with the trial and are deemed unsuitable for inclusion in the trial by the investigator;
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Other conditions that the investigator thinks are not suitable to participate in this clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tang-Du Hospital | Xi'an | Shaanxi | China | 710038 |
Sponsors and Collaborators
- Tang-Du Hospital
Investigators
- Study Director: Xin Wang, MD, PhD, Tang-Du Hospital
- Principal Investigator: Xiaodi Zhao, MD, PhD, Xi-Jing Hospital
- Principal Investigator: Yuanyuan Lu, MD, PhD, Xi-Jing Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- K202309-06