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

NCT06461910 ↗

Phase 2 Recruiting 30 enrolled Zekuan Xu

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2024-06-14
Primary completion: 2026-01-28
Completion: 2027-12

Publications

Xu H, Li F, Li B, Yang D, Liu T, Xia Y, Hua H, Li Q, Wang J, Liu H, Xu Z. Neoadjuvant immunochemotherapy plus thymalfasin in locally advanced gastric cancer: a prospective clinical trial. BMC Med. 2026 Feb 26;24(1):143. doi: 10.1186/s12916-026-04740-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Oxaliplatin	Small molecule	130 mg/m2	Intravenous
Subject	S-1	Small molecule	40 mg	Oral
Subject	S-1	Small molecule	50 mg	Oral
Subject	S-1	Small molecule	60 mg	Oral
Subject	Serplulimab	Monoclonal antibody	300 mg	Intravenous
Subject	Thymalfasin	Peptide	4.8 mg	Subcutaneous

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

Summary

Timeline

Publications

Drugs

Indications