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SBRT-LDRT-Cadonilimab for Advanced Gastric, Colorectal and Ovarian Cancers With Peritoneal Metastases

NCT06940921 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-04-27

No results posted yet for this study

Summary

The goal of this clinical trial is to see if high- and low-dose radiotherapy combined with immunotherapy can work in patients with advanced gastric, colorectal, and ovarian cancers with peritoneal metastases, and to learn about the safety of this new combination treatment modality. The main questions they aim to answer are:

* Can whole-abdominal low-dose radiotherapy (LDRT) combined with selected-site stereotactic body radiation therapy (SBRT) followed by Cadonilimab control peritoneal lesions and malignant ascites in patients with advanced solid tumors with peritoneal metastases?
* Can the novel treatment modality of high- and low-dose radiotherapy combined with immunotherapy produce a survival benefit in patients with advanced gastric, colorectal, and ovarian cancers who have received multiple lines of therapy?
* Is the safety profile of this new treatment modality acceptable?

Participants will:

* Receive stereotactic body radiation therapy (SBRT) to selected sites and low-dose radiotherapy (LDRT) to the whole abdomen, followed by bi-weekly treatment with Cadonilimab until disease progression, death, toxicity intolerance or withdrawal of informed consent.
* Receive whole body imaging and laboratory tests every 6-8 weeks to assess the efficacy of tumor treatment.

Conditions

  • Advanced Gastric Cancer
  • Advanced Colorectal Cancer
  • Advanced Ovarian Cancer
  • Peritoneal Metastasis

Interventions

RADIATION

Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT)

Radiation: Stereotactic Body Radiation Therapy (SBRT) * Stereotactic Body Radiation Therapy (SBRT) will be performed first at a total dose of 20-50 Gy, delivered in 3-5 fractions of 6-10 Gy each. And the target area was specifically selected based on the location and size of the patient's tumor. Radiation: low-dose radiotherapy (LDRT) * Whole-abdominal low-dose radiotherapy will be initiated within 10 days of the end of SBRT with a total dose of 7-15 Gy at 0.5-2.0 Gy twice daily. And the target area included all suspicious tumor tissues and potential metastatic foci in the abdominal cavity.

DRUG

Cadonilimab

· Cadonilimab: 6 mg/kg IV, D1, Q2W, until disease progression, death, toxicity intolerance or withdrawal of informed consent

Sponsors & Collaborators

  • Akeso Pharmaceuticals, Inc.

    collaborator OTHER

  • Zhang Tao

    lead OTHER

Principal Investigators

  • Zhang Tao, PhD · First Affiliated Hospital of Chongqing Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-20
Primary Completion
2027-11-30
Completion
2027-11-30

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 NCT06940921 on ClinicalTrials.gov