Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05963490
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-07-19
Brief Title:
Regorafenib Alone or in Combination With HypofractionatedLow-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Prospective Randomized Controlled Phase II Trial of Regorafenib Alone or in Combination With HypofractionatedLow-dose Radiotherapy Plus Toripalimab as Third-line Treatment in Patients With Metastatic Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLOT
Brief 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 11 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 hypofractionatedlow-dose radiotherapy Regorafenib and toripalimab will be continued after the completion of radiotherapy The survival benefits response rates and adverse effects will be analyzed
Detailed Description:
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 05-2Gy
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 05-2Gy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None