Cadonilimab (AK104) Combined With Chemotherapy and Bevacizumab as First-line Treatment for RAS Mutated or Right Sided-metastatic MSS Colorectal Cancer
NCT Number: NCT06566755
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Colorectal Cancer
Interventions: DRUG: Cadonilimab (AK104) combined with chemotherapy and bevacizumab
Sponsor: Caigang Liu
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-01
Completion Date: 2027-02-01
Locations: Shengjing Hospital of China Medical University, Shenyang, Liaoning, China

Summary:
The purpose of this study is to assess the efficacy and safety of Cadonilimab (AK104) combined with chemotherapy and bevacizumab as first-line treatment for patients with RAS mutated or right sided-metastatic MSS colorectal cancer

Primary Outcome Measures: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator, PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator will be presented., Up to approximately 1 year
Secondary Outcome Measures: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator, ORR is defined as the percentage of the participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters)., Up to approximately 1years|Disease control Rate (DCR) Per RECIST 1.1 as Assessed by Investigator, DCR is the rate of CR,PR plus SD, Up to approximately 1 year|Duration of Response (DoR) Per RECIST 1.1 as Assessed by Investigator, For participants who demonstrate CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR per RECIST 1.1 as assessed by Investigator will be presented., Up to approximately 1 year|Time to response（TTR）, The time from randomization to the first CR or PR recorded, Up to approximately 6 months|Overall Survival (OS), OS is defined as the time from randomization to death due to any cause., From randomization through 90 days after last dose of study treatment|Number of Participants Who Experience an Adverse Event (AE), An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented., From randomization through 30 days after last dose of study treatment|Number of Participants Who Experience a Serious AE (SAE), An SAE is defined as any untoward medical occurrence that, at any dose: a.) Results in death; b.) Is life-threatening; c.) Requires inpatient hospitalization or prolongation of existing hospitalization; d.) Results in persistent or significant disability/incapacity; e.) Is a congenital anomaly/birth defect; f.) Other important medical events; h.) Is a new cancer (that is not a condition of the study) or i.) Is associated with an overdose. The number of participants who experience an SAE will be presented., From randomization through 90 days after last dose of study treatment