RecruitingNot ApplicableNCT06128252

Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer

A Prospective, Multicentre, Double-blind Randomized Controlled Clinical Study of the Efficacy and Safety of Taurine Combined With Serplulimab and Chemotherapy Versus Serplulimab Combined With Chemotherapy for Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Sponsor

Tang-Du Hospital

Enrollment

96 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding the amino acid taurine to standard chemotherapy and immunotherapy (neoadjuvant treatment given before surgery) can improve outcomes for patients with locally advanced stomach or gastroesophageal junction cancer. **You may be eligible if:** - You are 18–75 years old with confirmed stage II or III stomach or gastroesophageal junction cancer (adenocarcinoma) - Your tumor expresses PD-L1 (a protein, with a score of 1 or more) - Your tumor is considered potentially removable with curative surgery - Your expected survival is at least 3 months - Your physical functioning is good (ECOG score 0–1) **You may NOT be eligible if:** - You have HER2-positive cancer - You used taurine supplements within the past month - You have gastrointestinal obstruction, active bleeding, perforation, or severe swallowing difficulty - You have HIV, AIDS, or an active autoimmune disease - You have serious heart, lung, liver, kidney, or psychiatric conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTTaurine

Taurine supplementation in tablets of 1.0 gram of taurine powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.

BIOLOGICALSerplulimab

Serplulimab

DRUGXELOX regimen

Oxaliplatin + capecitabine

DIETARY_SUPPLEMENTPlacebo

Taurine placebo in tablets of 1.0 gram of starch powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.

Locations(15)

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Affiliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, China

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Xi-jing Hospital

Xi'an, Shaanxi, China

Tang-Du Hospital

Xi'an, Shaanxi, China

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, China

Xi 'an International Medical Center Hospital

Xi'an, Shaanxi, China

The Second Affilated Hospital Of Xi'an Jiaotong University (Xibei Hospital)

Xi'an, Shaanxi, China

Xi'an NO.3 hospital

Xi'an, Shaanxi, China

The Third People's Hospital of Chengdu

Chengdu, Sichuan, China

Cancer Hospital Affiliated to Xinjiang Medical University

Ürümqi, Xinjiang Uygur Autonomous Region, China

The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)

Chongqing, China

The First Affiliated Hospital of Army Medical University (Southwest Hospital)

Chongqing, China

Army Specialty Medical Center of PLA (Daping Hospital)

Chongqing, China

Fudan University Shanghai Cancer Center (FUSCC)

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT06128252

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