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Thymosin-alpha-1

Thymalfasin, Zadaxin, Thymosin α1

Quick Stats
Studies 759
Trials 63
Recruiting PHASE2 INTERVENTIONAL NCT06461910

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

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

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).

Interventions

Name: Serplulimab
Type: DRUG
Description: 200 mg, i.v., D1, Q3W
Name: thymalfasin
Type: DRUG
Description: 4.8mg,sc,biw
Name: Oxaliplatin
Type: DRUG
Description: 130 mg/m2, i.v., D1, Q3W
Name: Tegafur
Type: DRUG
Description: 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

Primary Outcomes

Measure: pathological Complete Response (pCR)
TimeFrame: from preoperative to 10 days postoperative
Description: pCR was defined as no residual tumor cells on the histologic examination of surgical specimens.

Trial Information

NCT ID

NCT06461910

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Zekuan Xu

Last Updated

December 15, 2025