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This project aims to evaluate the efficacy and safety of oral taurine supplementation combined with PD-1 inhibitor (serplulimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with serplulimab and chemotherapy alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taurine + Serplulimab + XELOX | Experimental | Taurine + Serplulimab + XELOX chemotherapy regimen |
|
| Placebo + Serplulimab + XELOX | Active Comparator | Taurine placebo + Serplulimab + XELOX chemotherapy regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taurine | Dietary Supplement | Taurine supplementation in tablets of 1.0 gram of taurine powder. Dosage: 3.0 gram/day. Frequency: 3 time/day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response | To evaluate the pathologic complete response rate of locally advanced gastric cancer treated with concurrent serplulimab with chemotherapy with or without taurine supplementation. | Through study completion, Within 1 week after operation |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | The surgical margin is microscopically-negative for residual tumor. | Through study completion, Within 1 week after operation |
| Major pathological response (MPR) | Residual tumor cells below 10% in the resected specimen. |
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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 |
|---|---|---|---|---|---|---|
| Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
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Prospective, multicenter, double-blind, randomized controlled clinical study.
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| Serplulimab | Biological | Serplulimab |
|
| XELOX regimen | Drug | Oxaliplatin + capecitabine |
|
| Placebo | Dietary Supplement | Taurine placebo in tablets of 1.0 gram of starch powder. Dosage: 3.0 gram/day. Frequency: 3 time/day. |
|
| Through study completion, Within 1 week after operation |
| 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. | Through study completion, an average of 1 year. |
| Disease-free survival (DFS) | DFS was defined as the time from surgery to postoperative recurrence or death from any cause, whichever occurred first. DFS was censored on the last tumor assessment date for patients still alive and without recurrence. | Through study completion, an average of 1 year |
| Event-free survival (EFS) | EFS was the time from enrollment to recurrence or death from any cause. EFS was censored on the last tumor assessment date for patients still alive and without recurrence. | Through study completion, an average of 1 year |
| Overall survival (OS) | OS was the time from enrolment to death from any cause. OS was censored on the last date known to be alive for patients without documentation of death. | Through study completion, an average of 1 year |
| Quality of life | The quality of life was assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, EORTC QLQ-STO22 and Piper Fatigue Scale. | Through study completion, an average of 1 year] |
| Changes in CD8+ T cell infiltration in tumor tissue | 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 or surgical resection material assessed via flow cytometry and immunohistochemistry. | 1 year |
| 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. | Through study completion, an average of 1 year |
| Safety endpoints | 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. | Through study completion, an average of 1 year |
| Xi-Jing Hospital |
| Principal Investigator |
| Affiliated Drum Tower Hospital, Medical School of Nanjing University | Recruiting | Nanjing | Jiangsu | 210008 | China |
|
| The First Affiliated Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110001 | China |
|
| Xi-jing Hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| Tang-Du Hospital | Recruiting | Xi'an | Shaanxi | 710038 | China |
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| Shaanxi Provincial People's Hospital | Recruiting | Xi'an | Shaanxi | 710068 | China |
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| Xi 'an International Medical Center Hospital | Recruiting | Xi'an | Shaanxi | 710100 | China |
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| The Second Affilated Hospital Of Xi'an Jiaotong University (Xibei Hospital) | Recruiting | Xi'an | Shaanxi | China |
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| Xi'an NO.3 hospital | Recruiting | Xi'an | Shaanxi | China |
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| The Third People's Hospital of Chengdu | Recruiting | Chengdu | Sichuan | China |
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| Cancer Hospital Affiliated to Xinjiang Medical University | Recruiting | Ürümqi | Xinjiang Uygur Autonomous Region | 830000 | China |
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| The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital) | Recruiting | Chongqing | 400037 | China |
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| The First Affiliated Hospital of Army Medical University (Southwest Hospital) | Recruiting | Chongqing | 400038 | China |
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| Army Specialty Medical Center of PLA (Daping Hospital) | Recruiting | Chongqing | 400042 | China |
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| Fudan University Shanghai Cancer Center (FUSCC) | Recruiting | Shanghai | 200032 | China |
|
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D013654 | Taurine |
| C519688 | XELOX |
| ID | Term |
|---|---|
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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