RecruitingPhase 2NCT06461910

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


Sponsor

Zekuan Xu

Enrollment

30 participants

Start Date

Jun 14, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether adding immunotherapy (an anti-PD-1 drug) and thymalfasin (an immune-boosting agent) to standard SOX chemotherapy before surgery improves outcomes for people with Stage III stomach or gastroesophageal junction cancer. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with Stage III gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma confirmed by endoscopy and biopsy - Your cancer is HER2-negative and is considered surgically removable with curative intent - Your cancer has been assessed by CT scan and meets Stage III criteria - You are in good general health and can tolerate surgery **You may NOT be eligible if...** - You have had another cancer in the past 5 years (with some exceptions for early-stage skin or in-situ cancers) - You have had a blood transfusion within a certain time period before starting - You have had or are planning an organ or bone marrow transplant - You have uncontrolled infections or bleeding issues Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSerplulimab

300 mg, i.v., D1, Q3W

DRUGthymalfasin

4.8mg,sc,biw

DRUGOxaliplatin

130 mg/m2, i.v., D1, Q3W

DRUGTegafur

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


Locations(1)

The First Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

View Full Details on ClinicalTrials.gov

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NCT06461910


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