High- and Low-dose Radiotherapy Combined With PD-1 Inhibitors for MSS CRLM (HaRyPOT)
Colorectal Liver Metastases
About this trial
This is an interventional treatment trial for Colorectal Liver Metastases focused on measuring microsatellite stable, PD-1 Inhibitors, abscopal effects
Eligibility Criteria
Inclusion Criteria: Patients with microsatellite stable colorectal liver metastases and failure with second-line or above therapy, and no subsequent standard treatment regimen. Patients with an ECOG score of 0 or 1, and an expected survival period of ≥6 months. During the study, they are willing to follow the arrangement and not use other systemic anti-tumor drugs such as chemotherapy, targeted, Chinese herbal medicine, and proprietary Chinese medicine. 18-70 years old, no gender limit. Exclusion Criteria: Those with a history of severe immediate allergy to the drugs used in this study. Cancer patients who require urgent surgical intervention, such as high-risk pathological fractures, life-threatening bleeding symptoms, etc. Any of the following conditions in the 6 months before screening: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient cerebral ischemia Onset or symptomatic pulmonary embolism. Patients with known coronary artery disease, congestive heart failure that does not meet the above criteria or left ventricular ejection fraction <50% must adopt an optimized and stable medical plan determined by the treating doctor. If appropriate, you can consult a cardiologist. Patients with active infection requiring systemic treatment.
Sites / Locations
- Jiangsu Cancer HospitalRecruiting
Arms of the Study
Arm 1
Experimental
High- and Low-dose radiotherapy combined with immunotherapy.
All eligible patients will receive high-dose radiotherapy, followed by low-dose radiotherapy combined with PD-1 inhibitor therapy starting within 7 days after completion. The single dose of high-dose radiotherapy will be 6-8 Gy for 3-7 consecutive exposures, and the single dose of low-dose radiotherapy will be 0.5-1.4 Gy for 3-7 consecutive exposures.The PD-1 inhibitor (Zimberelimab) will be administered at the dose recommended in the specification every 3 weeks until disease progression, unacceptable toxicity, and withdrawal of informed consent by the patient.