This single-center, single-arm, prospective study plans to enroll patients with advanced colorectal cancer who have failed first-line or higher systemic therapies. Participants will receive a combination of iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), bevacizumab, and palliative radiotherapy. The efficacy and safety of this combination therapy will be evaluated by assessing objective response rate (ORR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety profile.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Conventional fractionation, low-dose hypofractionated radiotherapy, or high-dose hypofractionated radiotherapy may be employed.
5 mg/kg, intravenously infused on Day 1 of each cycle, administered every 3 weeks (with each cycle defined as 21 days).
35 mg/m², orally twice daily on Days 1 to 5 and Days 8 to 12 of each cycle, with each cycle spanning 28 days (4 weeks).
Jinan Central Hospital
Jinan, Shandong, China
ORR
The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
Time frame: approximately 4 months after the last subject participating in
PFS
the proportion of subjects with complete response (CR) and partial response (PR) according RESIST1.1 in total subjects.
Time frame: approximately 12 months after the last subject participating in
OS
The time from the starting date of study drug to the date of death due to any cause.
Time frame: approximately 12 months after the last subject participating in
DCR
The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD) in total subjects
Time frame: approximately 4 months after the last subject participating in
Safety (adverse event)
The rates of adverse events.
Time frame: Up to approximately 2 years.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
7.5 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.