Gastric Cancer
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTTaurine
Taurine supplementation in capsules of 1.0 gram of taurine powder. Dosage: 2.0 gram/day. Frequency: 2 time/day.
BIOLOGICALSintilimab
Sintilimab
DRUGXELOX regimen
Oxaliplatin + capecitabine
DRUGSOX regimen
Oxaliplatin + S-1 (tegafur/gimeracil/oteracil potassium)
DRUGFOLFOX regimen
Oxaliplatin + leucovorin + fluorouracil
Sponsors
Tang-Du Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Up to 24 months | PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on independent radiology review or death due to any cause, whichever occurs first. |
| Overall survival (OS) | Up to 24 months | OS was defined as the time from randomization to death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Up to 24 months | ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) according to RECIST 1.1 criteria. |
| Safety profile | Up to 24 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in CD8+ T cell death and function | Up to 24 months | 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. |
| Changes in CD8+ T cell infiltration in tumor tissue | Up to 24 months | 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 material assessed via immunohistochemistry. |
Countries
China
Contacts
Primary ContactXiaodi Zhao, MD, PhD
Backup ContactXin Wang, MD, PhD
Outcome results
None listed