Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

A Prospective, Randomized Controlled Clinical Study of The Efficacy and Safety of Taurine Combined With Serplulimab and Chemotherapy Versus Serplulimab Combined With Chemotherapy for Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06128252
• Other study ID #: K202308-01
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Tang-Du Hospital
• Contact: Xiaodi Zhao, MD, PhD
• Phone: 17702979587
• Email: leedyzhao[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project aims to evaluate the efficacy and safety of oral taurine supplementation combined with PD-1 inhibitor (serplulimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with serplulimab and chemotherapy alone.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18-75 years old, no gender limitation;

2. Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma with cTNM stage II/III;

3. Expected survival of = 3 months;

4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;

5. 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 the first dose of study treatment and throughout the study;

2. Patients with positive HER-2 and willing to receive herceptin treatment;

3. Patients with gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia;

4. Patients with severe heart, lung, liver, kidney, endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group;

5. Patients with other medical conditions that interfere with the trial and are deemed unsuitable for inclusion in the trial by the investigator;

6. Other conditions that the investigator thinks are not suitable to participate in this clinical trial.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Dietary Supplement:
• Taurine
Taurine supplementation in capsules of 1.0 gram of taurine powder. Dosage: 2.0 gram/day. Frequency: 2 time/day.

Biological:
• Serplulimab
Serplulimab

Drug:
• XELOX regimen
Oxaliplatin + capecitabine
• FLOT regimen
Fluorouracil + leucovorin + oxaliplatin + docetaxel

Locations

Country	Name	City	State
China	Tang-Du Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response	To evaluate the pathologic complete response rate of locally advanced gastric cancer treated with concurrent serplulimab with chemotherapy with or without taurine supplementation.	Through study completion, an average of 1 year
Secondary	R0 resection rate	The surgical margin is microscopically-negative for residual tumor.	Through study completion, an average of 1 year
Secondary	Major pathological response (MPR)	Residual tumor cells below 10% in the resected specimen.	Through study completion, an average of 1 year
Secondary	Disease-free survival (DFS)	DFS was defined as the time from surgery to postoperative recurrence or death from any cause, whichever occurred first. DFS was censored on the last tumor assessment date for patients still alive and without recurrence.	Through study completion, an average of 1 year
Secondary	Event-free survival (EFS)	EFS was the time from enrollment to recurrence or death from any cause. EFS was censored on the last tumor assessment date for patients still alive and without recurrence.	Through study completion, an average of 1 year
Secondary	Overall survival (OS)	OS was the time from enrolment to death from any cause. OS was censored on the last date known to be alive for patients without documentation of death.	Through study completion, an average of 1 year
Secondary	Changes in CD8+ T cell infiltration in tumor tissue	Changes in number, effector (TNF-a, IFN-?, etc.) production and immune checkpoint molecule (PD-1, CTLA-4, etc.) expression of tumor-infiltrating CD8+ T cells in gastric cancer endoscopic biopsy or surgical resection material assessed via flow cytometry and immunohistochemistry.	1 year
Secondary	Changes in CD8+ T cell death and function	Changes in number, apoptosis rate, effector (TNF-a, IFN-?, etc.) production and immune checkpoint molecule (PD-1, CTLA-4, etc.) expression of CD8+ T cells in peripheral venous blood assessed via flow cytometry.	Through study completion, an average of 1 year
Secondary	Safety endpoints	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.	Through study completion, an average of 1 year