Active — Not RecruitingPhase 1/2

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

China26 participantsStarted 2025-03-20

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * With his/her own consent and signed Informed Consent Form (ICF), willingness and ability to comply with planned visits, study treatments, laboratory tests and other experimental procedures. * At the time of signing the ICF, the subject must be ≥ 18 years of age with a life expectancy of ≥ 12 weeks. * Gastric, colorectal, or ovarian cancer diagnosed by pathologic histology or cytology. And accompanied by peritoneal metastasis confirmed by pathohistology or cytology or imaging (CT/MRI/PET-CT). * Advanced or metastatic gastric cancer, colorectal cancer, ovarian cancer (AJCC/UICC stage IV) confirmed by imaging of the chest, abdomen and pelvis (CT/MRI/PET-CT). * Previously received multiple lines of systemic antitumor therapy, no longer available or refused standard treatment. * At least 1 measurable lesion other than the lesion to be treated with SBRT according to RECIST 1.1 criteria. For lesions that have received prior radiotherapy, only a definite progression of that lesion is considered a measurable lesion. * An Eastern Cooperative Oncology Group physical status score (ECOG) of 0-1. * Appropriate organ function based on the following laboratory test values obtained during the Screening Period: white blood cell count ≥ 3 x 109/L, neutrophil count ≥ 1.5 x 109/L, platelet count 75 x 109/L; serum total bilirubin ≤ 1.5 x upper limit of normal (ULN), alanine aminotransferase or aspartate aminotransferase or ≤ 2.5 x UNL (hepatic metastasis) subjects should be …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Peritoneal response rate

Timeframe: within 3 years after primary treatment

Trial details

NCT IDNCT06940921

SponsorZhang Tao

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-11-30

View on ClinicalTrials.gov More Advanced Gastric Cancer trials