Status:
UNKNOWN
High- and Low-dose Radiotherapy Combined With PD-1 Inhibitors for MSS CRLM
Lead Sponsor:
Jiangsu Cancer Institute & Hospital
Conditions:
Colorectal Liver Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This pilot phase I trial aims to investigate the efficacy and safety of high- and low-dose radiotherapy combined with programmed cell death-1 (PD-1) inhibitors in microsatellite stable (MSS) metastati...
Detailed Description
This pilot phase I trial aims to investigate the efficacy and safety of high- and low-dose radiotherapy combined with programmed cell death-1 (PD-1) inhibitors in microsatellite stable (MSS) metastati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06045286
Start Date
September 20 2023
End Date
December 31 2025
Last Update
September 21 2023
Active Locations (1)
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1
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210009