KRAS is a common genetic mutation in tumors, and CRC is one of the tumors with a high KRAS mutation rate. The anti-tumor activity of KRAS G12C inhibitors combined with anti-EGFR anti-bodies have been proven in patients with advanced colorectal cancer, and one of them was approved for patients who have previously received standard treatment. However, Chinese patients still do not have access to these drugs. This study is to determine the efficacy and safety of KRAS G12C inhibitor JAB-21822 in combination with the second-line standard chemotherapy and bevacizumab in advanced colorectal cancer failed to standard therapy in Chinese population.
The study is aimed for patients with histologically confirmed advanced metastatic colorectal cancer with KRAS G12C mutation, patients enrolled will treated with JAB-21822 combined with standard second-line chemotherapy and bevacizumab until disease progression or intolerable toxicity or patient-initiated withdrawal from the study. Enrolled patients will undergo imaging assessments at baseline and every 6 weeks during the treatment period, the anti-tumor efficacy will be evaluated by the investigator according to RECIST v1.1. Safety assessment included vital signs, haematology, blood biochemistry and urinalysis and will be monitored regularly during the study period during treatment. Any discomfort experienced by the patients after administration of the drug will also be recorded.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Tablet, oral, 800 mg/QD, until PD or intolerable toxicity
The second line standard chemotherapy regimen recommended by clinical practice
5mg/kg every two weeks (according to the assessment by investigator)
Beijing Cancer Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Peking University Cancer Hospital (Inner Mongolia Campus)/Afffliated Cancer Hospital of Inner Mongolia Medical University
Hohhot, China
Fudan University Shanghai Cancer Center
Shanghai, China
Objective Response Rate (ORR)
The percentage of patients with total number of Complete Response (CR) + total number of Partial Response (PR) per RECIST v1.1
Time frame: Time Frame: up to 1year
Overall Survival (OS)
Defined as the time from date of study treatment to death due to any cause.
Time frame: Time Frame: up to 1 year
Progression-free Survival (PFS)
Defined as the time from date of study treatment to disease progression radiological/clinical or death due to any cause, whichever occurs first.
Time frame: Time Frame: up to 1 year
Disease Control Rate (DCR)
Defined as the percentage of patients whose best response are not Progressive Disease (PD) according to RECIST v1.1.
Time frame: Time Frame: up to 1 year
Duration of Response (DOR)
Defined as the time between the first assessment of the tumor as a CR or PR and the first assessment as disease progression (PD) or death from any cause.
Time frame: Time Frame: up to 1 year
Rate of treatment-related adverse events
Number of patients with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: Time Frame: up to 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.