Locally advanced or metastatic colorectal cancer
Conditions
Interventions
Experimental Group:immunoradiotherapy + Irinotecan Liposome + Iparomlimab and Tuvonralimab + Bevacizumab
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects have good compliance, can understand the research process of this study, and sign a written ICF; 2. Age> = 18 years old, gender is not limited; 3. Confirmed diagnosis of mCRC by histopathology or cytopathology; 4. Failure of previous first-line oxaliplatin-containing systemic therapy (definition of treatment failure: disease progression or intolerance during the last line of systemic therapy for metastatic colorectal cancer or within 3 months after treatment; First-line therapy failure is considered if recurrence or metastasis occurs during or within 6 months of adjuvant/neoadjuvant therapy or within 6 months of completion); 5. Have at least one reproducibly assessable lesion according to RECIST1.1 criteria; 6. ECOG 0-2 points; 7. Expected survival time >= 3 months; 8. Bone marrow function: neutrophil (ANC) > = 1.5×10^9/L, platelets (PLT) > = 100×10^9/L, hemoglobin (Hb) >=90g/L, white blood cell (WBC) >=3.0×10^9/L; 9. Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) =60 mL/min (calculated according to Cockroft-Gault), urine protein <2+; 11. Coagulation function: normal coagulation function (international normalized ratio INR<=1.5); 12. Patients need to have proper nutritional status; 13. Non-pregnant or lactating females; Females/males of childbearing potential should use effective contraception for the duration of the study and for 6 months after the end of study treatment.
Exclusion criteria
Exclusion criteria: 1.Prior treatment with irinotecan, liposomal irinotecan, or PD-1/PD-L1 inhibitors. 2.Uncontrolled recurrent effusions requiring frequent drainage (more than once per month), including pleural, pericardial, or peritoneal effusions. 3.History of other malignancies within the past 3 years (except cured carcinoma in situ or basal cell skin cancer). 4.Active brain metastases or leptomeningeal metastasis. 5.Concurrent use of strong CYP3A4 inducers within 3 weeks prior to the first dose, or strong CYP3A4 inhibitors/UGT1A1 inhibitors within 3 weeks prior to the first dose. 6.Major organ surgery within 4 weeks before the first dose of the study drug (excluding needle biopsy, central venous catheter placement, port placement, biliary stenting, percutaneous biliary drainage, or cholecystostomy) or planned elective surgery. 7.Active infections, including: HIV infection, Active chronic HBV/HCV (e.g., HBV DNA >=10^4 copies/mL or >=2000 IU/mL; antiviral therapy must be initiated to reduce HBV DNA to =2 per NCI-CTCAE v5.0: >=4 stools/day over baseline, significant ostomy output, limiting daily activities). 10.Severe psychiatric disorders. 11.Known hypersensitivity to any component of the study drug. 12.Participation in other clinical trials within 4 weeks prior to enrollment. 13.Pregnancy, lactation, or refusal to use effective contraception during the trial and for 6 months post-treatment (for patients of childbearing potential). 14.Investigator judgment of unsuitability for the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Disease Control Rate;Duration of Response; | — |
Countries
China
Contacts
Public ContactBaorui Liu
Nanjing Drum Tower Hospital
Outcome results
None listed