colorectal cancer liver metastases
Conditions
Interventions
Experimental group:cardonilizumab in combination with regorafenib
Sponsors
Huashan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Be not allergic to regorafenib or cadonilimab; 2) Age: 18 to 75 years old, men and women are not limited; 3) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; 4) Histological or cytological confirmed adenocarcinoma of colon or rectum with liver metastases, with or without extrahepatic metastases; 5) Measurable disease as determined by response evaluation criteria in solid tumors (RECIST) v1.1; 6) Progression (radiologically or clinically) or intolerance to no more than two (for extended RAS mutant) or three (for extended RAS wild type) lines of systemic chemotherapy. Prior systemic therapy should include fluoropyrimidines, irinotecan, oxaliplatin, anti-vascular endothelial growth factor (VEGF) therapy, and, if extended rat sarcoma viral oncogene homolog (RAS) wild type, an anti-epidermal growth factor receptor (EGFR) therapy; 7) Known extended RAS and BRAF status; 8) pMMR status confirmed by immunohistochemistry or MSS status confirmed by next generation sequencing (NGS)/polymerase chain reaction (PCR); 9) For the evaluation of PD-L1 tissues and plasma before treatment; 10) Child-Pugh grade A: SB 35 g/L; 11) Hematologic function: white cell count (WBC) > 2.5 x 109/L, platelets =60 x109/L, prothrombin time (PT) prolongation <2s; 12) Patients of childbearing potential must be willing to use highly effective contraception for the duration of the study and for =120 days after the last dose of cadonilimab; female patients with a negative urine or serum pregnancy test result within =3 days prior to the first dose of the drug; 13 Able to understand and voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: 1) Women who are pregnant or breastfeeding 2) Patients previously treated with regorafenib, fruquintinib, TAS102 or other anti-angiogenic small molecule TKI drugs, such as anlotinib, apatinib, sorafenib etc; Or previously use of anti-PD-1, anti-PD-L1, anti-cytotoxic T-lymphocyte-associated antigen (CTLA-4) antibody or etc.; 3) Active autoimmune disease requiring systemic therapy within the past 2 years (e.g., treatment with disease-modifying drugs, corticosteroids, immunosuppressants), replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid therapy for adrenal or pituitary insufficiency) is not considered a systemic treatment; 4) Active or prior history of definite inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea); 5) Patients who have receivedinterventional therapy, ablation or radiotherapy for liver metastases within the past 3 months; 6) Patients with an expected survival time of less than 3 months; 7) Study participants with other malignant tumors within 3 years prior to enrollment, excluding cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.); 8) Patients with severe psychological or psychiatric abnormalities; 9) Patients with severe arrhythmia, heart failure, severe ventilatory dysfunction and severe lung infection, acute and chronic renal failure; 10) Concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study; 11) Any other clinically significant disease or condition that, in the opinion of the investigator, may affect adherence to the protocol, or the signing of the Informed Consent Form (ICF) by the subject, or make participation in this clinical trial inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression free survival;Overall survival;Safety;Duration of response; | — |
Countries
China
Contacts
Public ContactChen Jinhong
Huashan Hospital Fudan University
Outcome results
None listed