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Recruiting Phase 2 NCT06461910

Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma

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Trial Parameters

Condition Gastric Cancer
Sponsor Zekuan Xu
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-06-14
Completion 2026-01-28
Interventions
SerplulimabthymalfasinOxaliplatin

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Brief 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 (Serplulimab) with thymalfasin and the SOX chemotherapy regimen as a neoadjuvant treatment for patients with clinical stage III gastric or gastroesophageal junction(GEJ) adenocarcinoma.

Eligibility Criteria

Inclusion Criteria: * Age and Diagnosis: Patients aged 18-75 years with gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma, regardless of gender. * Stage and Diagnosis Confirmation: According to the 8th edition of AJCC staging for gastric cancer, patients must be assessed via abdominal CT as cStage III (cT3-4aN1-3M0). Diagnosis must be confirmed by endoscopy and pathology as G/GEJ adenocarcinoma (HER-2 negative). Only patients with Siewert type III and type II (who do not require combined thoracic surgery) GEJ cancer are eligible. * Surgical Assessment: Tumors must be deemed resectable with curative intent (R0 resection) as determined by a gastrointestinal surgeon and a radiologist. Patients must agree to undergo radical surgery and be deemed operable by a surgeon. * Previous Treatments: Patients must not have received prior systemic treatment for the current disease, including surgery, anti-tumor chemotherapy, radiotherapy, or immunotherapy. * Survival Expectancy: Expected

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