Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally 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 (serplulimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with serplulimab and chemotherapy alone.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Taurine + Serplulimab + investigator's choice chemotherapy Taurine + Serplulimab + XELOX or Taurine + Serplulimab + FLOT |
Dietary Supplement: Taurine
Taurine supplementation in capsules of 1.0 gram of taurine powder. Dosage: 2.0 gram/day. Frequency: 2 time/day.
Biological: Serplulimab
Serplulimab
Drug: XELOX regimen
Oxaliplatin + capecitabine
Drug: FLOT regimen
Fluorouracil + leucovorin + oxaliplatin + docetaxel
|
| Active Comparator: Serplulimab + investigator's choice chemotherapy Serplulimab + XELOX or Serplulimab + FLOT |
Biological: Serplulimab
Serplulimab
Drug: XELOX regimen
Oxaliplatin + capecitabine
Drug: FLOT regimen
Fluorouracil + leucovorin + oxaliplatin + docetaxel
|
Outcome Measures
Primary Outcome Measures
- Pathological complete response [Through study completion, an average of 1 year]
To evaluate the pathologic complete response rate of locally advanced gastric cancer treated with concurrent serplulimab with chemotherapy with or without taurine supplementation.
Secondary Outcome Measures
- R0 resection rate [Through study completion, an average of 1 year]
The surgical margin is microscopically-negative for residual tumor.
- Major pathological response (MPR) [Through study completion, an average of 1 year]
Residual tumor cells below 10% in the resected specimen.
- Disease-free survival (DFS) [Through study completion, an average of 1 year]
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.
- Event-free survival (EFS) [Through study completion, an average of 1 year]
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.
- Overall survival (OS) [Through study completion, an average of 1 year]
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.
- Changes in CD8+ T cell infiltration in tumor tissue [1 year]
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.
- Changes in CD8+ T cell death and function [Through study completion, an average of 1 year]
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.
- Safety endpoints [Through study completion, an average of 1 year]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18-75 years old, no gender limitation;
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Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma with cTNM stage II/III;
-
Expected survival of ≥ 3 months;
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Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
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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 the first dose of study treatment and throughout the study;
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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 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.- K202308-01