At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years old
- ✓ECOG performance status ≤1
- ✓Life expectancy of at least 3 months
- ✓Histopathologically confirmed MSS/pMMR adenocarcinoma of colon or rectum
- ✕Prior treatment with regorafenib and ICIs (anti-PD-1 or anti-PD-L1)
- ✕Current severe cardiovascular disease: unstable angina, congestive heart failure, serious cardiac arrhythmia
- ✕Acute cardiac infarction or cerebral ischemic stroke within 6 months before recruitment
- ✕Active autoimmune disease, immunodeficiency, history of organ transplantation, or systematic immunosuppressive agents
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05963490Phase 2RecruitingUpdate OverdueUpdated 21mo ago · Completion was 14mo agoA Prospective, Randomized, Controlled Phase II Trial of Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab as Third-line Treatment in Patients With Metastatic Colorectal Cancer
In Brief
A Phase 2 clinical trial evaluating Regorafenib, Toripalimab, and 1 other intervention for Microsatellite Stable Metastatic Colorectal Cancer. Currently recruiting, targeting 108 participants across 1 site.
Signals
Detailed Summary
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.
Study Details
Timeline
Interventions
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.