NCT06128252

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P25-P50 for not_applicable gastric-cancer

Timeline
11mo left

Started Sep 2024

Typical duration for not_applicable gastric-cancer

Geographic Reach
1 country

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Sep 2024Jun 2027

First Submitted

Initial submission to the registry

November 2, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

2.8 years

First QC Date

November 2, 2023

Last Update Submit

June 8, 2026

Conditions

Gastric Cancer

Keywords

Taurineneoadjuvant immunotherapy and chemotherapy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (10)

  • R0 resection rate

    Through study completion, Within 1 week after operation

  • Major pathological response (MPR)

    Through study completion, Within 1 week after operation

  • Objective response rate (ORR)

    Through study completion, an average of 1 year.

  • Disease-free survival (DFS)

    Through study completion, an average of 1 year

  • Event-free survival (EFS)

    Through study completion, an average of 1 year

  • +5 more secondary outcomes

Study Arms (2)

Taurine + Serplulimab + XELOX

EXPERIMENTAL

Taurine + Serplulimab + XELOX chemotherapy regimen

Dietary Supplement: TaurineBiological: SerplulimabDrug: XELOX regimen

Placebo + Serplulimab + XELOX

ACTIVE COMPARATOR

Taurine placebo + Serplulimab + XELOX chemotherapy regimen

Biological: SerplulimabDrug: XELOX regimenDietary Supplement: Placebo

Interventions

TaurineDIETARY_SUPPLEMENT

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

Taurine + Serplulimab + XELOX
SerplulimabBIOLOGICAL

Serplulimab

Placebo + Serplulimab + XELOXTaurine + Serplulimab + XELOX
XELOX regimenDRUG

Oxaliplatin + capecitabine

Placebo + Serplulimab + XELOXTaurine + Serplulimab + XELOX
PlaceboDIETARY_SUPPLEMENT

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

Placebo + Serplulimab + XELOX

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

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

Wuhan, Hubei, China

RECRUITING

Affiliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210008, China

RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

Xi-jing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Tang-Du Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, 710068, China

RECRUITING

Xi 'an International Medical Center Hospital

Xi'an, Shaanxi, 710100, China

RECRUITING

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

Xi'an, Shaanxi, China

RECRUITING

Xi'an NO.3 hospital

Xi'an, Shaanxi, China

RECRUITING

The Third People's Hospital of Chengdu

Chengdu, Sichuan, China

RECRUITING

Cancer Hospital Affiliated to Xinjiang Medical University

Ürümqi, Xinjiang Uygur Autonomous Region, 830000, China

RECRUITING

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

Chongqing, 400037, China

RECRUITING

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

Chongqing, 400038, China

RECRUITING

Army Specialty Medical Center of PLA (Daping Hospital)

Chongqing, 400042, China

RECRUITING

Fudan University Shanghai Cancer Center (FUSCC)

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

TaurineXELOX

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Alkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Xin Wang, MD, PhD

    Tang-Du Hospital

    STUDY DIRECTOR

  • Xiaodi Zhao, MD, PhD

    Xi-Jing Hospital

    PRINCIPAL INVESTIGATOR

  • Yuanyuan Lu, MD, PhD

    Xi-Jing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaodi Zhao, MD, PhD

CONTACT

17702979587leedyzhao@fmmu.edu.cn

Xin Wang, MD, PhD

CONTACT

13571826689wangx@fmmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, multicenter, double-blind, randomized controlled clinical study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2023

First Posted

November 13, 2023

Study Start

September 1, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

June 9, 2026

Record last verified: 2026-06

Locations

CN(15)