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Trial Title:
Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer
NCT ID:
NCT06123455
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Taurine
Description:
Taurine supplementation in capsules of 1.0 gram of taurine powder. Dosage: 2.0 gram/day.
Frequency: 2 time/day.
Arm group label:
Taurine + Sintilimab + investigator's choice chemotherapy
Intervention type:
Biological
Intervention name:
Sintilimab
Description:
Sintilimab
Arm group label:
Sintilimab + investigator's choice chemotherapy
Arm group label:
Taurine + Sintilimab + investigator's choice chemotherapy
Intervention type:
Drug
Intervention name:
XELOX regimen
Description:
Oxaliplatin + capecitabine
Arm group label:
Sintilimab + investigator's choice chemotherapy
Arm group label:
Taurine + Sintilimab + investigator's choice chemotherapy
Intervention type:
Drug
Intervention name:
SOX regimen
Description:
Oxaliplatin + S-1 (tegafur/gimeracil/oteracil potassium)
Arm group label:
Sintilimab + investigator's choice chemotherapy
Arm group label:
Taurine + Sintilimab + investigator's choice chemotherapy
Intervention type:
Drug
Intervention name:
FOLFOX regimen
Description:
Oxaliplatin + leucovorin + fluorouracil
Arm group label:
Sintilimab + investigator's choice chemotherapy
Arm group label:
Taurine + Sintilimab + investigator's choice chemotherapy
Summary:
This project aims to evaluate the efficacy and safety of oral taurine supplementation
combined with PD-1 inhibitor (sintilimab) and chemotherapy in inducing systemic CD8+ T
cell responses and achieving improved gastric cancer patient outcomes than with
sintilimab and chemotherapy alone.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18 or older, no gender limitation;
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:
1. Use of taurine agent within 1 month prior to randomization on this study;
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tang-Du Hospital
Address:
City:
Xi'an
Zip:
710038
Country:
China
Status:
Recruiting
Contact:
Last name:
Xin Wang, MD, PhD
Phone:
13571826689
Email:
wangx@fmmu.edu.cn
Contact backup:
Last name:
Jia Yu, MD
Phone:
1862928617
Email:
yj1862928617@163.com
Start date:
August 1, 2023
Completion date:
July 31, 2025
Lead sponsor:
Agency:
Tang-Du Hospital
Agency class:
Other
Source:
Tang-Du Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06123455
