Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525428
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Standard Systemic Therapy Combined With HighLow-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Two-cohort Phase II Trial of Standard Systemic Therapy in Combination With HighLow-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
TORCH-M is a prospective single-arm two-cohort investigator-initiated phase II trial to investigate the efficacy and safety of standard systemic therapy in combination with highlow-dose radiotherapy plus toripalimab in paitents with microsatellite stable metastatic colorectal cancer MSS mCRC Eligible patients will be assigned to two cohorts according to previous treatment a first-line cohort A and a second-line cohort B Patients in both arms will first receive one cycle of standard systemic therapy and toripalimab followed by highlow-dose radiotherapy and then continue with standard systemic therapy and toripalimabThe survival benefits response rates and adverse effects will be analyzed
Detailed Description:
First-line standard systemic therapies in cohort A include FOLFOXXELOX bevacizumab FOLFOXXELOXcetuximab KRASNRASBRAF WT and left-sided tumors only FOLFIRINOX bevacizumab
Second-line standard systemic therapies in cohort B include FOLFOXXELOX bevacizumab FOLFOXXELOXcetuximab KRASNRASBRAF WT FOLFIRIirinotecanraltitrexedirinotecanbevacizumab FOLFIRIirinotecanraltitrexedirinotecancetuximab KRASNRASBRAF WT based on the previous first-line chemotherapy and adverse events
Toripalimab will be delivered at 240 mg q3w Radiotherapy regimes include 4-8 fractions of 4-12Gy via SABR or hypofractionated radiotherapy HFRT and 5 fractions of 05-2Gy via LDRT
Second-line standard systemic therapies in cohort B include FOLFOXXELOX bevacizumab FOLFOXXELOXcetuximab KRASNRASBRAF WT FOLFIRIirinotecanraltitrexedirinotecanbevacizumab FOLFIRIirinotecanraltitrexedirinotecancetuximab KRASNRASBRAF WT based on the previous first-line chemotherapy and adverse events
Toripalimab will be delivered at 240 mg q3w Radiotherapy regimes include 4-8 fractions of 4-12Gy via SABR or hypofractionated radiotherapy HFRT and 5 fractions of 05-2Gy via LDRT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None