RecruitingPhase 2NCT06487429

Short Course Radiotherapy With Sequential Disitamab Vedotin Combined With S-1 and Sintilimab as Whole Course Neoadjuvant Therapy for HER2 Expressed Locally Progressive Gastric Cancer

Prospective, Phase II Clinical Study of Short Course Radiotherapy With Sequential Disitamab Vedotin Combined With S-1 and Sintilimab as Whole Course Neoadjuvant Therapy for HER2 Expressed Locally Progressive Gastric Cancer


Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Enrollment

28 participants

Start Date

May 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective, open label, phase II clinical study intended to include patients with locally advanced gastric adenocarcinoma who have not undergone any treatment and are eligible for surgery. The study aims to evaluate the efficacy and safety of the short course sequential radiotherapy regimen of Disitamab Vedotin combined with S-1 and Sintilimab in neoadjuvant therapy for HER2 expressing locally advanced gastric cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of four treatments given before surgery — short-course radiotherapy, disitamab vedotin (an antibody-drug conjugate targeting HER2), the chemotherapy drug S-1, and sintilimab (an immunotherapy) — in people with locally advanced HER2-expressing stomach cancer. **You may be eligible if...** - You are between 18 and 75 years old - You have locally advanced gastric or gastroesophageal junction cancer confirmed by tissue testing, with stage cT3-4N+M0 (cancer has not spread distantly) - Your tumor tests positive for HER2 expression (IHC 1+, 2+, or 3+) - You have not received any prior treatment for this cancer - You have a good performance status (ECOG 0-1) and adequate organ function - Your tumor is considered resectable (surgeons believe it can be removed) **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have already received any cancer treatment (chemotherapy, radiation, immunotherapy) - You are pregnant or breastfeeding - You have significant organ dysfunction 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGShort range radiotherapy with sequential Disitamab Vedotin combined with S-1 and xindilizumab

Short range radiotherapy, PCTV (clinical planned target area) DT 25Gy/5F, once a day, for a total of 5 days, continuous irradiation, and IMRT (intensity modulated radiation therapy) technology; After a week of rest, radiotherapy and chemotherapy combined with immunotherapy will be performed * Disitamab Vedotin: 2.5 mg/kg, intravenous infusion, d1, Q3W; * Sintilimab: 200mg, iv; * S-1: 40 mg/dose, oral, bid, d1-14; Q3W Whether to undergo adjuvant therapy after surgery is determined by the researcher


Locations(1)

Zhang Tao

Wuhan, Hubei, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06487429


Related Trials