Clinical trial NCT06123455: Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer
Official title: A Prospective, Randomized Controlled Clinical Study of The Efficacy and Safety of Taurine Combined With Sintilimab and Chemotherapy Versus Sintilimab Combined With Chemotherapy for Treatment of Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to 24 months
measure: Overall survival (OS)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 24 months
measure: Safety profile
timeFrame: Up to 24 months
Other outcomes:
measure: Changes in CD8+ T cell death and function
timeFrame: Up to 24 months
measure: Changes in CD8+ T cell infiltration in tumor tissue
timeFrame: Up to 24 months
Locations:
city: Xi'an
country: China
facility: Tang-Du Hospital
state: Shaanxi
Study officials:
affiliation: Tang-Du Hospital
name: Xin Wang, MD, PhD
role: STUDY_DIRECTOR
affiliation: Xi-Jing Hospital
name: Xiaodi Zhao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xi-Jing Hospital
name: Yuanyuan Lu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: