This study is a prospective, multi-arm, phase II clinical trial that uses transcriptome profiling to guide the evaluation of the efficacy of multiple lines of standard chemotherapy and bevacizumab combined with adebrelimab in patients with MSS-type metastatic colorectal cancer, aiming to expand the immunotherapy cohort while accurately narrowing the population of MSS-type colorectal cancer that benefits from immunity. This study includes a screening period, a treatment period, and a follow-up period.
This study plans to include a total of 100 first-line, second-line, and third-line MCRIH (MSS Colorectal Cancer Immuno-Hot) participants. First-line and second-line participants who pass the screening period will receive standard chemotherapy (XELOX/mXELIRI: conventional dose) combined with Bevacizumab (7.5mg/kg, q3w) and Adebrelimab (1200mg, q3w); third-line subjects will receive Fruquintinib (4mg po d1\~d14, q3w) combined with Adebrelimab (1200mg, q3w). Participants will receive imaging examinations during the treatment period to evaluate efficacy and progression. In addition, any adverse reactions at any time will be recoded to evaluate safety. The EDC system will be used to collect statistics on participants examination data.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Adebrelimab: 1200mg,q3w Bevacizumab: 7.5mg/kg,q3w Fruquintinib: 4mg po d1\~d14, q3w Chemotherapy: XELOX/mXELIRI: conventional dose
Objective Response Rate
The percentage of people in a study or treatment group who have a partial response or complete response to the treatment within a certain period of time according to RECIST 1.1.
Time frame: 2 years
Disease Control Rate
The percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents according to RECIST 1.1.
Time frame: 2 years
Progression Free Survival
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works according to the results of RECIST 1.1.
Time frame: 2 years
Overall Survical
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. In a clinical trial, measuring the overall survival is one way to see how well a new treatment works.
Time frame: 2 years
QoL
QoL will be eveluated based on EORTC QLQ-C30
Time frame: 2 years
Incidence of Treatment-related Adverse Events (Safety )
This will be evaluated based on NCI CTCAE, including the number of participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.
Time frame: 2 years
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