pMMR/MSS advanced colorectal cancer
Conditions
Interventions
Treatment group:Cadonilimab in combination with regorafenib
Sponsors
National Cancer Center/Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 75 years old, men and women are not limited; 2. Advanced colorectal cancer diagnosed by histology or cytology; 3. Tumor tissue with pMMR status confirmed by immunohistochemistry or MSS status confirmed by second-generation sequencing (NGS)/polymerase chain reaction (PCR); 4. For Patients who have failed at least two prior systemic therapy regimens, initial therapy must include fluorouracil, irinotecan, oxaliplatin, anti-VEGF monoclonal antibodies (not limited to bevacizumab) and/or anti-EGFR monoclonal antibodies for patients with RAS wild-type. Prior therapy may also include (neo)adjuvant chemotherapy in the case of disease relapse during treatment or within 6 months of the last (neo)adjuvant therapy; 5. ECOG PS score 0-1; 6. Have measurable lesions that meet RECIST 1.1 criteria; 7. Expected survival = 3 months; 8. Normal function of major organs, no severe blood abnormalities, heart, lung, liver, kidney function, and immunodeficiency diseases; 9. Normal coagulation function, no active bleeding or thrombotic disease; 10. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and voluntarily use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of the study drug; For men, they should be surgically sterilized or agree to use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of the study drug; 11. Patients voluntarily enrolled in this study and signed an informed consent form (ICF); 12. Patients are expected to have good compliance and be able to follow up on efficacy and adverse effects as required by the protocol.
Exclusion criteria
Exclusion criteria: 1. Other malignancies diagnosed within 5 years prior to first administration of study drug, except effectively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or effectively resected in situ cervical and/or breast cancer; 2. Symptomatic central nervous system metastases; 3. Patients with previous immune checkpoint inhibitors; 4. Patients previously treated with similar VEGFR-TKI small molecule drugs, including but not limited to anlotinib, furoquitinib, apatinib, and lenvatinib; 5. Have any active autoimmune disease or history of autoimmune disease; 6. Suffering from congenital or acquired immune deficiency; 7. Immunosuppressive drug use within 14 days prior to first study drug use; 8. Live attenuated vaccine administered within 4 weeks prior to the first dose or planned during the study period; 9. Have an uncontrolled cardiac clinical condition or disease; 10. Have multiple factors that affect the absorption of orally administered drugs; 11. Patients with risk of gastrointestinal bleeding; 12. Those with hemoptysis within 1 month prior to study entry; 13. Need for long-term anticoagulation with warfarin or heparin, or need for long-term antiplatelet therapy; 14. Complicated severe infection within 4 weeks prior to first dose; 15. Major surgery, open biopsy or significant trauma within 28 days prior to enrollment; 16. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 17. People with thrombosis-like diseases or treated with anticoagulant drugs; 18. Pregnant or breastfeeding women; patients of childbearing potential who are unwilling or unable to use effective contraception; 19. Other conditions deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate, DCR;Progression free survival, PFS;Overall Survival, OS;Safety; | — |
Countries
China
Contacts
Public ContactJing Huang
National Cancer Center/Chinese Academy of Medical Sciences
Outcome results
None listed