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A Study on Immunotherapy Combined With Radiotherapy for Esophagogastric Junction/Gastric Adenocarcinoma

NCT07053332 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-07-08

No results posted yet for this study

Summary

A single-arm, prospective phase II clinical study of neoadjuvant PD-1/CTLA-4 combination antibody with low-dose radiotherapy in resectable dMMR/MSI-H esophagogastric junction/gastric adenocarcinoma.

Conditions

  • Esophagogastric Junction/Gastric Adenocarcinoma

Interventions

DRUG

PD-1/CTLA-4 combination antibody with low-dose radiotherapy

* PD-1/CTLA-4 combination antibody: Iparomlimab and Tuvonralimab， 5mg/kg on day 1, day 22, and day 43, administered via intravenous infusion, for a total of three cycles before surgery and maintained for up to 1 year after surgery. * Radiotherapy: To be conducted within one week of the start of immunotherapy, with a total dose of DT: 30Gy, 2.5Gy × 12 fractions, once daily, five times per week. The preoperative radiotherapy target area will be delineated by the radiation oncologist in accordance with the "NCCN Guidelines for Gastric/Esophagogastric Junction Cancers 2022" and in consultation with the opinions of the general surgeon. * Surgery: Surgical treatment will be completed within 3-5 weeks after the completion of neoadjuvant therapy. * Adjuvant therapy: Postoperative immunotherapy will be maintained for up to 1 year.

Sponsors & Collaborators

  • Jiangsu Cancer Institute & Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2027-12-31
Completion
2029-08-12

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07053332 on ClinicalTrials.gov