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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taurine | Dietary Supplement | Taurine supplementation in capsules of 1.0 gram of taurine powder. Dosage: 2.0 gram/day. Frequency: 2 time/day. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in CD8+ T cell death and function | 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. | Up to 24 months |
| Changes in CD8+ T cell infiltration in tumor tissue |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaodi Zhao, MD, PhD | Contact | 17702979587 | leedyzhao@fmmu.edu.cn | |
| Xin Wang, MD, PhD | Contact | 13571826689 | wangx@fmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xin Wang, MD, PhD | Tang-Du Hospital | Study Director |
| Xiaodi Zhao, MD, PhD | Xi-Jing Hospital | Principal Investigator |
| Yuanyuan Lu, MD, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tang-Du Hospital | Recruiting | Xi'an | Shaanxi | 710038 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013654 | Taurine |
| C000632826 | sintilimab |
| C519688 | XELOX |
| C410216 | Folfox protocol |
| ID | Term |
|---|---|
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
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| Sintilimab | Biological | Sintilimab |
|
| XELOX regimen | Drug | Oxaliplatin + capecitabine |
|
| SOX regimen | Drug | Oxaliplatin + S-1 (tegafur/gimeracil/oteracil potassium) |
|
| FOLFOX regimen | Drug | Oxaliplatin + leucovorin + fluorouracil |
|
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 |
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. |
| Up to 24 months |
| Xi-Jing Hospital |
| Principal Investigator |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D009930 |
| Organic Chemicals |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |