Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer
NCT ID: NCT06128252
Last Updated: 2025-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
96 participants
INTERVENTIONAL
2024-09-01
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Taurine + Serplulimab + XELOX
Taurine + Serplulimab + XELOX chemotherapy regimen
Taurine
Taurine supplementation in tablets of 1.0 gram of taurine powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.
Serplulimab
Serplulimab
XELOX regimen
Oxaliplatin + capecitabine
Placebo + Serplulimab + XELOX
Taurine placebo + Serplulimab + XELOX chemotherapy regimen
Serplulimab
Serplulimab
XELOX regimen
Oxaliplatin + capecitabine
Placebo
Taurine placebo in tablets of 1.0 gram of starch powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.
Interventions
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Taurine
Taurine supplementation in tablets of 1.0 gram of taurine powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.
Serplulimab
Serplulimab
XELOX regimen
Oxaliplatin + capecitabine
Placebo
Taurine placebo in tablets of 1.0 gram of starch powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.
Eligibility Criteria
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Inclusion Criteria
2. Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma with cTNM stage II/III，T≥3, N ≥0, M=0；
3. Expected survival of ≥ 3 months;
4. The tumor specimens were PD-L1 positive (CPS ≥ 1)；
5. There is a measurable lesion with the possibility of radical R0 resection after evaluation by doctors；
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
7. Patients informed about the purpose and course of the study and provided a written consent to participate.
Exclusion Criteria
2. Patients with positive HER-2；
3. Patients with gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia;
4. Patients with severe heart, lung, liver, kidney, endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group;
5. Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS) or autoimmune disease or immunosuppressant use；
6. 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.
18 Years
75 Years
ALL
No
Sponsors
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Tang-Du Hospital
OTHER
Responsible Party
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Principal Investigators
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Xin Wang, MD, PhD
Role: STUDY_DIRECTOR
Tang-Du Hospital
Xiaodi Zhao, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Xi-Jing Hospital
Yuanyuan Lu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Xi-Jing Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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K202308-01
Identifier Type: -
Identifier Source: org_study_id
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