Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer
NCT ID: NCT06123455
Last Updated: 2023-11-08
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
PHASE2
60 participants
INTERVENTIONAL
2023-08-01
2025-07-31
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
SINGLE
Study Groups
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Taurine + Sintilimab + investigator's choice chemotherapy
Taurine + Sintilimab + XELOX or Taurine + Sintilimab + SOX or Taurine + Sintilimab + FOLFOX
Taurine
Taurine supplementation in capsules of 1.0 gram of taurine powder. Dosage: 2.0 gram/day. Frequency: 2 time/day.
Sintilimab
Sintilimab
XELOX regimen
Oxaliplatin + capecitabine
SOX regimen
Oxaliplatin + S-1 (tegafur/gimeracil/oteracil potassium)
FOLFOX regimen
Oxaliplatin + leucovorin + fluorouracil
Sintilimab + investigator's choice chemotherapy
Sintilimab + XELOX or Sintilimab + SOX or Sintilimab + FOLFOX
Sintilimab
Sintilimab
XELOX regimen
Oxaliplatin + capecitabine
SOX regimen
Oxaliplatin + S-1 (tegafur/gimeracil/oteracil potassium)
FOLFOX regimen
Oxaliplatin + leucovorin + fluorouracil
Interventions
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Taurine
Taurine supplementation in capsules of 1.0 gram of taurine powder. Dosage: 2.0 gram/day. Frequency: 2 time/day.
Sintilimab
Sintilimab
XELOX regimen
Oxaliplatin + capecitabine
SOX regimen
Oxaliplatin + S-1 (tegafur/gimeracil/oteracil potassium)
FOLFOX regimen
Oxaliplatin + leucovorin + fluorouracil
Eligibility Criteria
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Inclusion Criteria
2. Pathologically confirmed gastric cancer or adenocarcinoma of the gastroesophageal junction, local lesions cannot be radically resected or metastatic gastric cancer;
3. Expected survival of ≥ 3 months;
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
5. At least one measurable lesion outside the stomach (RECIST 1.1);
6. Patients informed about the purpose and course of the study and provided a written consent to participate.
Exclusion Criteria
2. Patients received prior systemic therapy for gastric cancer;
3. Patients with operable gastric cancer;
4. Patients with positive HER-2 and willing to receive herceptin treatment;
5. Patients with gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia;
6. Patients with active autoimmune disease that has required systemic treatment in past 2 years;
7. Patients diagnosed as immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy;
8. Patients with severe heart, lung, liver, kidney, endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group;
9. Patients with other medical conditions that interfere with the trial and are deemed unsuitable for inclusion in the trial by the investigator;
10. Other conditions that the investigator thinks are not suitable to participate in this clinical trial.
18 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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Tang-Du 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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K202309-06
Identifier Type: -
Identifier Source: org_study_id
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