Combining taurine with sintilimab and chemotherapy for advanced gastric cancer treatment

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

This study tests if adding taurine to the cancer drug sintilimab and chemotherapy can help people with advanced gastric cancer feel better and respond better to treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tang-Du Hospital (Academic / other)
• Drugs / interventions: sintilimab, chemotherapy
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT06123455 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and efficacy of oral taurine supplementation in conjunction with the PD-1 inhibitor sintilimab and standard chemotherapy regimens for patients with advanced gastric cancer. The goal is to enhance systemic CD8+ T cell responses and improve patient outcomes compared to sintilimab and chemotherapy alone. Participants will be monitored for their response to treatment and any potential side effects. The study aims to provide insights into the effectiveness of this combination therapy in a Phase 2 setting.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older with pathologically confirmed advanced gastric cancer or gastroesophageal junction adenocarcinoma that cannot be surgically removed.

Not a fit: Patients with operable gastric cancer or those who have received prior systemic therapy for gastric cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients with advanced gastric cancer.

How similar studies have performed: While the combination of taurine with immunotherapy and chemotherapy is a novel approach, similar studies have shown promise in enhancing treatment responses in various cancers.

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.

Where this trial is running

Xi'an, Shaanxi

• Tang-Du Hospital — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Principal investigator: Xiaodi Zhao, MD, PhD — Xi-Jing Hospital
• Study coordinator: Xiaodi Zhao, MD, PhD

Conditions Gastric Cancer