Clinical trial NCT06940921: SBRT-LDRT-Cadonilimab for Advanced Gastric, Colorectal and Ovarian Cancers With Peritoneal Metastases
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
Conditions: Advanced Gastric Cancer
Advanced Colorectal Cancer
Advanced Ovarian Cancer
Peritoneal Metastasis
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.
Interventions:
description: Radiation: Stereotactic Body Radiation Therapy (SBRT)<br/>* 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.<br/>Radiation: low-dose radiotherapy (LDRT)<br/>* 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.
name: Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT)
type: Radiation
description: · Cadonilimab: 6 mg/kg IV, D1, Q2W, until disease progression, death, toxicity intolerance or withdrawal of informed consent
name: Cadonilimab
type: Drug
Study arms:
design_group_description: Patients in the experimental arm will receive stereotactic body radiation therapy (SBRT) to selected tumor sites and low-dose radiotherapy (LDRT) to the whole abdomen, followed by Cadonilimab immunotherapy.
design_group_title: Whole abdominal LDRT combined with SBRT followed by Cadonilimab group
design_group_type: Experimental
Sponsor: Chongqing Medical University /The First Affiliated Hospital/
Collaborators: Akeso Pharmaceuticals, Inc.
Drug name mappings:
name: 卡度尼利单抗
lang: CN
name: Cadonilimab
lang: EN