The study compares the efficacy and safety of regorafenib alone or in combination with hypofractionated radiotherapy and low-dose radiotherapy (LDRT) plus toripalimab in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC). Patients are randomly assigned (1:1) into the control arm and the experimental arm. Control arm: a total of 54 patients will receive regorafenib monotherapy. Experimental arm: a total of 54 patients will first receive 1 cycle of regorafenib and toripalimab followed by hypofractionated/low-dose radiotherapy. Regorafenib and toripalimab will be continued after the completion of radiotherapy. The survival benefits, response rates, and adverse effects will be analyzed.
Control arm: regorafenib 120 mg orally once daily on days 1-21 of each 28 days cycle. Experimental arm: regorafenib is administered 80 mg once daily on days 1-21 of each 28 days cycle with intravenous toripalimab 240 mg every 3 weeks. Radiotherapy regimes include hypofractionated radiotherapy (5 fractions of 4-12Gy) and low-dose radiotherapy (5 fractions of 0.5-2Gy).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Regorafenib 120 mg orally once daily on days 1-21 of each 28 days cycle.
240 mg intravenously every 3 weeks
hypofractionated radiotherapy (5 fractions of 4-12Gy) and low-dose radiotherapy (5 fractions of 0.5-2Gy).
Regorafenib 80mg orally once daily on days 1-21 of each 28 days cycle.
Fudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGOS
Defined as the time from initiation of treatment to death from any cause.
Time frame: Up to 2 years
PFS
Defined as the time from initiation of treatment to PD or death from any cause.
Time frame: Up to 2 years
DCR
The percentage of patients with disease control in all metastatic lesions. Disease control is defined as CR, PR, or stable disease (SD) per RECIST v1.1 and iRECIST after treatment.
Time frame: Up to 1 year
ORR
The percentage of patients with objective response in all metastatic lesions.
Time frame: Up to 1 year
DoR
Defined as the time between PR/CR and subsequent progression disease (PD) per RECIST v1.1 and iRECIST or death from any cause.
Time frame: Up to 1 year
Adverse events
The percentage of patients with treatment-related acute toxicities as assessed by NCI CTCAE v5.0, from treatment initiation until 90 days upon completion of immunotherapy.
Time frame: Up to 1 year
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