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A Sequential Trial of Low-Dose Radiotherapy Followed by Concurrent Immunotherapy, Systemic Chemotherapy, and Intraperitoneal Perfusion in Gastric Cancer With Peritoneal Carcinomatosis

NCT07784413 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-25

No results posted yet for this study

Summary

This study is a prospective, single-center, open-label, exploratory phase II clinical trial aimed at evaluating the safety, tolerability, and preliminary efficacy of low-dose radiotherapy (LDR) sequentially combined with serplulimab, bevacizumab analog, and irinotecan or albumin-bound paclitaxel in patients with gastric cancer and peritoneal metastases. A total of 40 patients with gastric adenocarcinoma who have previously undergone first-line therapy are planned for enrollment. Patients will be grouped based on prior exposure to paclitaxel-based chemotherapy to determine whether they will receive systemic treatment with irinotecan combined with serplulimab or albumin-bound paclitaxel combined with serplulimab, along with local intraperitoneal infusion of bevacizumab analog. The study adopts a Simon two-stage design, with 20 patients enrolled in the first stage. If ≥3 patients achieve objective remission, the study will proceed to the second stage, enrolling an additional 20 patients.

Conditions

  • Gastric Cancer Peritoneal Metastasis (GCPM)

Interventions

DRUG

low-dose radiotherapy (LDR) sequentially combined with serplulimab, bevacizumab analog, and irinotecan or albumin-bound paclitaxel

low-dose radiotherapy (LDR) sequentially combined with serplulimab, bevacizumab analog, and irinotecan or albumin-bound paclitaxel

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Principal Investigators

  • Qi Xu, Master · Zhejiang Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-09-01
Completion
2029-07-30

Countries

  • China

Study Locations

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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 NCT07784413 on ClinicalTrials.gov