NCT06461910

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

The Efficacy and Safety of Anti-PD-1 Combined With Thymalfasin and SOX in Neoadjuvant Treatment of cStage III Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Open-label, Single-arm, Phase II Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Zekuan Xu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, open-label, single-arm phase II clinical study to assess the efficacy and safety of Serplulimab in combination with thymalfasin and SOX regimen for neoadjuvant therapy of locally advanced gastric cancer. It is planned to enroll 30 patients with HER2-negative gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology and/or cytology who were clinically staged as stage III resectable G/GEJ carcinoma as assessed by endoscopic ultrasonography, CT/MRI and other imaging. The primary endpoint of the study was pathological complete response (pCR) rate. The secondary end points included major pathological response(MPR) rate, Tumor Regression Grade (TRG), Clinical downstaging rate (T and/or N downstaging), Objective Response Rate (ORR), Disease Control Rate (DCR), R0 resection rate, Disease-free Survival (DFS), Overall Survival (OS) and treatment-related adverse events (TRAEs).

Conditions

• Gastric Cancer
• Esophagogastric Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Serplulimab	300 mg, i.v., D1, Q3W
DRUG	thymalfasin	4.8mg,sc,biw
DRUG	Oxaliplatin	130 mg/m2, i.v., D1, Q3W
DRUG	Tegafur	oral administration: body surface area \< 1.25, 40 mg each time; body surface area ≥ 1.25 to \< 1.5, 50 mg each time; body surface area ≥ 1.5, 60 mg each time, twice daily for each treatment cycle at D1-D14

Timeline

• Start date: 2024-06-14
• Primary completion: 2026-01-28
• Completion: 2027-12-01
• First posted: 2024-06-17
• Last updated: 2026-03-03

Locations

1 site across 1 country: China