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NCT Number: NCT06128252

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-75 years old, no gender limitation;
  • Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma with cTNM stage II/III,T≥3, N ≥0, M=0;
  • Expected survival of ≥ 3 months;
  • The tumor specimens were PD-L1 positive (CPS ≥ 1);
  • There is a measurable lesion with the possibility of radical R0 resection after evaluation by doctors;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  • Patients informed about the purpose and course of the study and provided a written consent to participate.

Exclusion criteria

  • Use of taurine agent within 1 month prior to the first dose of study treatment and throughout the study;
  • Patients with positive HER-2;
  • Patients with gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia;
  • Patients with severe heart, lung, liver, kidney, endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group;
  • Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS) or autoimmune disease or immunosuppressant use;
  • There are patients who may increase the risk of participating in the study and study medication, or other severe, acute and chronic diseases, and are not suitable for participating in the clinical study according to the judgment of the investigator.

Treatment and study plan

Taurine

Dietary Supplement

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

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.

Primary outcomes

  1. Pathological complete response

    Time frame: Through study completion, Within 1 week after operation

    To evaluate the pathologic complete response rate of locally advanced gastric cancer treated with concurrent serplulimab with chemotherapy with or without taurine supplementation.

Secondary outcomes

  1. R0 resection rate

    Time frame: Through study completion, Within 1 week after operation

    The surgical margin is microscopically-negative for residual tumor.

  2. Major pathological response (MPR)

    Time frame: Through study completion, Within 1 week after operation

    Residual tumor cells below 10% in the resected specimen.

  3. Objective response rate (ORR)

    Time frame: Through study completion, an average of 1 year.

    ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.

  4. Disease-free survival (DFS)

    Time frame: 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.

  5. Event-free survival (EFS)

    Time frame: 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.

  6. Overall survival (OS)

    Time frame: 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.

  7. Quality of life

    Time frame: Through study completion, an average of 1 year]

    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.

  8. Changes in CD8+ T cell infiltration in tumor tissue

    Time frame: 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.

  9. Changes in CD8+ T cell death and function

    Time frame: 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.

  10. Safety endpoints

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaodi Zhao, MD, PhD

CONTACT

[email protected]

17702979587

Xin Wang, MD, PhD

CONTACT

[email protected]

13571826689

Sponsors and collaborators

Lead sponsor

Tang-Du Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 13, 2023
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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