This study is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of Candonilimab (AK104) combined with Regorafenib for the treatment of MSS colorectal liver metastasis. Candonilimab (AK104) is a humanized IgG1 bispecific antibody that targets PD-1 and CTLA-4.
This is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of Candonilimab (AK104) combined with Regorafenib for the treatment of MSS colorectal liver metastasis. The purpose of the study is to observe and evaluate the efficacy and safety of Cadonilimab in combination with Regorafenib in patients with CRLM who had failed the previous second-line standard regimen, and to explore biomarkers related to efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Cadonilimab (AK104): 6mg/kg, i.v. q2w.
Regorafenib: 80 mg p.o. qd for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off).
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGHuashan Hospital
Shanghai, China
RECRUITINGShanghai Tenth People's Hospital
Shanghai, China
RECRUITINGObjective Response Rate (ORR)
ORR, determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
Time frame: 6 months
Disease Control Rate (DCR)
DCR, determined using RECIST v1.1, defined as the percentage of subjects whose best response was not PD (= total number of CR + PR + SD; CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating)
Time frame: 6 months
Duration of response (DoR)
DoR, determined using RECIST v1.1, defined as the time from the first judgment of CR or PR to the discovery of PD after treatment.
Time frame: 6 months
Progression-free Survival (PFS)
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.
Time frame: 6 months
Overall survival (OS)
OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Time frame: 2 years
Adverse event incidence rate (AE rate)
Safety variables will be summarized using descriptive statistics based on adverse events collection.
Time frame: 6 months
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