Clinical trial NCT06128252: Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer
Official title: A Prospective, Multicentre, Double-blind 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Keywords: Taurine
neoadjuvant immunotherapy and chemotherapy
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multicenter, double-blind, randomized controlled clinical study.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Age 18-75 years old, no gender limitation;
2. Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma with cTNM stage II/III，T≥3, N ≥0, M=0；
3. Expected survival of ≥ 3 months;
4. The tumor specimens were PD-L1 positive (CPS ≥ 1)；
5. There is a measurable lesion with the possibility of radical R0 resection after evaluation by doctors；
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
7. 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；
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. Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS) or autoimmune disease or immunosuppressant use；
6. There are patients who may increase the risk of participating in the study and study medication, or other severe, acute and chronic diseases, and are not suitable for participating in the clinical study according to the judgment of the investigator.

Primary outcomes:
measure: Pathological complete response
timeFrame: Through study completion, Within 1 week after operation
Secondary outcomes:
measure: R0 resection rate
timeFrame: Through study completion, Within 1 week after operation
measure: Major pathological response (MPR)
timeFrame: Through study completion, Within 1 week after operation
measure: Objective response rate (ORR)
timeFrame: Through study completion, an average of 1 year.
measure: Disease-free survival (DFS)
timeFrame: Through study completion, an average of 1 year
measure: Event-free survival (EFS)
timeFrame: Through study completion, an average of 1 year
measure: Overall survival (OS)
timeFrame: Through study completion, an average of 1 year
measure: Quality of life
timeFrame: Through study completion, an average of 1 year]
measure: Changes in CD8+ T cell infiltration in tumor tissue
timeFrame: 1 year
measure: Changes in CD8+ T cell death and function
timeFrame: Through study completion, an average of 1 year
measure: Safety endpoints
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xi-jing Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Tang-Du Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Shaanxi Provincial People's Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xi 'an International Medical Center Hospital
state: Shaanxi
city: Xi'an
country: China
facility: The Second Affilated Hospital Of Xi'an Jiaotong University (Xibei Hospital)
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an NO.3 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: