Microsatellite Stable Metastatic Colorectal Cancer Clinical Trial
Official title:
A Prospective, Randomized, Controlled Phase II Trial of Regorafenib Alone or in Combination With High/Low-dose Radiotherapy Plus Toripalimab as Third-line Treatment in Patients With Metastatic Colorectal Cancer
The study compares the efficacy and safety of regorafenib alone or in combination with stereotactic ablative radiotherapy (SABR) 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 45 patients will receive regorafenib monotherapy. Experimental arm: a total of 45 patients will first receive 1 cycle of regorafenib and toripalimab followed by SABR/LDRT radiotherapy. Regorafenib and toripalimab will be continued after the completion of radiotherapy. The objective response rate (ORR), survival benefits, 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 4-8 fractions of 8-12Gy via SABR and up to 1-10Gy at 0.5-2Gy/fraction via LDRT. ;