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) metastatic colorectal cancer (mCRC) that have failed second-line immunotherapy or above.
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) metastatic colorectal cancer (mCRC) that have failed second-line immunotherapy or above. 30 participants will be enrolled in this study. All will take part at Jiangsu Cancer Hospital.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
High-dose radiotherapy (6-8Gy×3-7F) followed by low-dose radiotherapy (0.5-1.4Gy×3-7F) starting within 7 days after completion.
Immunotherapy (Zimberelimab) is given every three weeks within one week after the end of high-dose radiotherapy.
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
RECRUITINGObjective response rate (ORR)
The proportion of patients showing complete or partial response of low-dose radiotherapy lesions and other metastatic lesions assessed by RECIST v1.1
Time frame: 1,3,6, and 12 months after completion of radiotherapy
Progression-free survival (PFS)
From the start of treatment to the date of progression or death
Time frame: 12 months
Overall survival (OS)
the time from the start of treatment to death from any cause
Time frame: 12 months
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