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ACTIVE NOT RECRUITING
NCT06940921
PHASE1/PHASE2

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

Sponsor: Zhang Tao

View on ClinicalTrials.gov

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.

Official title: A Single-arm, Prospective Clinical Study of Low-dose Radiation Therapy (LDRT) Combined With Stereotactic Body Radiation Therapy (SBRT) and Cadonilimab for Advanced Gastric, Colorectal and Ovarian Cancers With Peritoneal Metastases

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2025-03-20

Completion Date

2027-11-30

Last Updated

2025-04-27

Healthy Volunteers

No

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

Locations (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China