Gastric CancerNCT06128252
Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer
A study testing Taurine, Serplulimab and XELOX regimen in people with Gastric Cancer, run by Tang-Du Hospital at 15 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Taurine, Serplulimab and XELOX regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 15 sitesChina
- Study dates
- 1 Sep 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
The Third People's Hospital of Chengdu
Chengdu, Sichuan
Yingxin Wu, Master, 028-61312288, wuyingxin510@126.com
Yingxin Wu, PhD
- Recruiting
The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Chongqing, 400037
Weidong Xiao, PhD, 023-68755114, xiaoweidong@tmmu.edu.cn
Weidong Xiao, PhD
- Recruiting
The First Affiliated Hospital of Army Medical University (Southwest Hospital)
Chongqing, 400038
Yan Shi, PhD, 023-68754000, shiyandoctor@sina.com
Yan Shi, PhD
- Recruiting
Army Specialty Medical Center of PLA (Daping Hospital)
Chongqing, 400042
Fan Li, PhD, 023-68757113, levine@163.com
Fan Li, PhD
- Recruiting
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210008
Jia Wei, PhD, 025-83106666, jiawei99@nju.edu.cn
Jia Wei, PhD
- Recruiting
Fudan University Shanghai Cancer Center (FUSCC)
Shanghai, 200032
Hua Huang, PhD, 021-64175590, huahuang@fudan.edu.cn
Hua Huang, PhD
- Recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
Zhenning Wang, PhD, 024-83283333, znwang@cmu.edu.cn
Zhenning Wang, PhD
- Recruiting
Cancer Hospital Affiliated to Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region, 830000
Wenbin Zhang, PhD, 0991-7968088, zwb3216@sina.com
Wenbin Zhang, PhD
- Recruiting
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
Guihua Wang, PhD, 027-83662640, ghwang@tjh.tjmu.edu.cn
Guihua Wang, PhD
- Recruiting
Xi-jing Hospital
Xi'an, Shaanxi, 710032
Jipeng Li, PhD, 13991316190, jipengli1974@aliyun.com
Jipeng Li, PhD
- Recruiting
Tang-Du Hospital
Xi'an, Shaanxi, 710038
Xin Wang, MD, PhD, 13571826689, wangx@fmmu.edu.cn
Jia Yu, MD, 1862928617, yj1862928617@163.com
- Recruiting
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068
Ruiting Liu, PhD, 13008428826, fg-peter@126.com
Ruiting Liu, PhD
- Recruiting
Xi 'an International Medical Center Hospital
Xi'an, Shaanxi, 710100
Qingchuan Zhao, PhD, 029-84771534, zhaoqc@fmmu.edu.cn
Qingchuan Zhao, PhD
- Recruiting
The Second Affilated Hospital Of Xi'an Jiaotong University (Xibei Hospital)
Xi'an, Shaanxi
Zhidong Wang, PhD, 029-87679386, xawzd@163.com
Zhidong Wang, PhD
- Recruiting
Xi'an NO.3 hospital
Xi'an, Shaanxi
Tongfei Wang, PhD, 029-61302013, yf991310@163.com
Tongfei Wang, PhD
About this study
Official 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
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.
- Conditions
- Gastric Cancer
- Being tested
- Taurine, Serplulimab, XELOX regimen, Placebo
- Keywords
- Taurine, neoadjuvant immunotherapy and chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaurineDietary supplement
Taurine supplementation in tablets of 1.0 gram of taurine powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.
SerplulimabBiological
Serplulimab
XELOX regimenDrug
Oxaliplatin + capecitabine
PlaceboDietary supplement
Taurine placebo in tablets of 1.0 gram of starch powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.
| Study group | Role | What they receive |
|---|---|---|
| Taurine + Serplulimab + XELOX | Experimental | Taurine + Serplulimab + XELOX chemotherapy regimen Receives: Dietary Supplement: Taurine; Biological: Serplulimab; Drug: XELOX regimen |
| Placebo + Serplulimab + XELOX | Active comparator | Taurine placebo + Serplulimab + XELOX chemotherapy regimen Receives: Biological: Serplulimab; Drug: XELOX regimen; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, Within 1 week after operation
Secondary outcomes (10)
R0 resection rate
The surgical margin is microscopically-negative for residual tumor.
Measured: Through study completion, Within 1 week after operation
Major pathological response (MPR)
Residual tumor cells below 10% in the resected specimen.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Sep 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, double-blind, randomized controlled clinical study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Wang, MD, PhD, Study director, Tang-Du HospitalXiaodi Zhao, MD, PhD, Principal investigator, Xi-Jing HospitalYuanyuan Lu, MD, PhD, Principal investigator, Xi-Jing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128252
- Sponsor's protocol ID
- K202308-01
- Status last verified
- Jun 2026
- First submitted
- 2 Nov 2023
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06128252
- Acronym / sponsor ID
- K202308-01
- Conditions
- Gastric Cancer
- Keywords
- Taurine, neoadjuvant immunotherapy and chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, multicenter, double-blind, randomized controlled clinical study.
| Arm | Type | Receives |
|---|---|---|
| Taurine + Serplulimab + XELOX | Experimental | Dietary Supplement: Taurine, Biological: Serplulimab, Drug: XELOX regimenTaurine + Serplulimab + XELOX chemotherapy regimen |
| Placebo + Serplulimab + XELOX | Active comparator | Biological: Serplulimab, Drug: XELOX regimen, Dietary Supplement: PlaceboTaurine placebo + Serplulimab + XELOX chemotherapy regimen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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；
Key exclusion criteria (6 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TaurineTaurine supplementation in tablets of 1.0 gram of taurine powder. Dosage: 3.0 gram/day. Frequency: 3 time/day. | Dietary supplement | Taurine + Serplulimab + XELOX |
| SerplulimabSerplulimab | Biological | Placebo + Serplulimab + XELOX, Taurine + Serplulimab + XELOX |
| XELOX regimenOxaliplatin + capecitabine | Drug | Placebo + Serplulimab + XELOX, Taurine + Serplulimab + XELOX |
| PlaceboTaurine placebo in tablets of 1.0 gram of starch powder. Dosage: 3.0 gram/day. Frequency: 3 time/day. | Dietary supplement | Placebo + Serplulimab + XELOX |
Primary outcome
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.
10 secondary outcomes
R0 resection rate
Time frame: Through study completion, Within 1 week after operation
Major pathological response (MPR)
Time frame: Through study completion, Within 1 week after operation
Objective response rate (ORR)
Time frame: Through study completion, an average of 1 year.
Disease-free survival (DFS)
Time frame: Through study completion, an average of 1 year
Event-free survival (EFS)
Time frame: Through study completion, an average of 1 year
Overall survival (OS)
Time frame: Through study completion, an average of 1 year
Quality of life
Time frame: Through study completion, an average of 1 year]
Changes in CD8+ T cell infiltration in tumor tissue
Time frame: 1 year
Changes in CD8+ T cell death and function
Time frame: Through study completion, an average of 1 year
Safety endpoints
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xin Wang, MD, PhD study director
Tang-Du Hospital
Xiaodi Zhao, MD, PhD principal investigator
Xi-Jing Hospital
Yuanyuan Lu, MD, PhD principal investigator
Xi-Jing Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taurine, Serplulimab and XELOX regimen in people with Gastric Cancer, run by Tang-Du Hospital at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaodi Zhao, MD, PhD (17702979587, leedyzhao@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (time frame: Through study completion, Within 1 week after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.