Efficacy and Safety of Anti-PD-1, Thymosin, and SOX in Neoadjuvant Treatment of cStage III Gastric/GEJ Adenocarcinoma
NCT Number: NCT06461910
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Gastric Cancer|Esophagogastric Junction Adenocarcinoma
Interventions: DRUG: Anti-PD-1 Combined with Thymosin and SOX
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2027-12

Summary:
This Phase II clinical study is a prospective, open-label, single-arm trial designed to evaluate the efficacy and safety of combining anti-PD-1 therapy (sintilimab) with thymosin α1 and the SOX chemotherapy regimen as a neoadjuvant treatment for patients with clinical stage III gastric or esophagogastric junction (GEJ) adenocarcinoma. The primary objective is to explore the therapeutic efficacy and safety of this combined treatment approach. The secondary objective is to assess its impact on the tumor immune microenvironment in locally advanced gastric cancer.

Study Design

The study plans to enroll 30 patients who have been pathologically confirmed as HER2-negative and diagnosed with resectable stage III gastric or GEJ adenocarcinoma (Siewert type III and type II without the need for thoracotomy). The study includes multiple steps:

Treatment Regimen: Participants will receive three cycles of sintilimab combined with the SOX regimen (oxaliplatin and S-1) and nine weeks of thymosin α1 before surgery.

Assessment Points: Tumor response will be evaluated through imaging studies at the end of the second and third cycles of neoadjuvant therapy. Post-treatment surgery is scheduled within 2-6 weeks following the last dose of the third cycle.

Pathological Evaluation: Surgical tumor samples will undergo pathological examination, including assessments for pathological complete response (pCR), tumor regression grade (TRG), major pathological response (MPR), overall response rate (ORR), disease control rate (DCR), clinical downstaging rate, and R0 resection rate.

Safety Monitoring: Adverse events will be monitored throughout the treatment period to evaluate the safety of the neoadjuvant immunochemotherapy regimen.

Follow-up: Patients will be followed up to calculate disease-free survival (DFS) and overall survival (OS).

Eligibility Criteria

Inclusion Criteria:

i, Confirmed diagnosis of HER2-negative gastric or GEJ adenocarcinoma. ii. Clinical stage III, resectable tumors. iii. Adequate organ function and performance status.

Exclusion Criteria:

i. Prior treatment with immune checkpoint inhibitors. ii. History of autoimmune diseases or other malignancies. iii. Severe comorbidities that could interfere with the study.

Goals and Objectives Primary Goal: To determine the effectiveness and safety of combining sintilimab with thymosin α1 and SOX as a neoadjuvant therapy.

Secondary Goal: To investigate changes in the tumor immune microenvironment induced by the treatment and their correlation with therapeutic efficacy.

Study Implications This study aims to provide critical insights into the potential benefits of integrating immunotherapy with chemotherapy and thymosin α1 in treating locally advanced gastric cancer. By focusing on both efficacy and immune microenvironment alterations, the findings could pave the way for novel neoadjuvant treatment strategies and improve clinical outcomes for gastric cancer patients.

Primary Outcome Measures: pathological Complete Response, pCR, Duration: Each cycle is 3 weeks (21 days) for a total of 3 cycles (9 weeks).Postoperative Follow-Up Period: Year 1: Every 3 months Years 1-2: Every 6 months