Colorectal cancer
Conditions
Interventions
Experimental group :fruquintinib+cadonilimab+standard chemotherapy
Sponsors
Xuancheng People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Participants aged between 18 to 75 years inclusive (both 18 and 75 years old); 2. Understand the study procedures and content, and voluntarily sign a written informed consent form; 3. Histologically and/or cytologically confirmed advanced or metastatic colorectal adenocarcinoma, all other histological types are excluded; 4. Have at least one measurable lesion according to RECIST 1.1 criteria; 5. Failure of first-line standard treatment (disease progression or intolerance after treatment with fluorouracil-based or oxaliplatin-based chemotherapy with or without bevacizumab); KRAS wild-type patients must have disease progression or intolerance after anti-EGFR targeted therapy. (Note: If a patient discontinues treatment for reasons other than disease progression, they are considered intolerant to this treatment); 6. Adjuvant/neoadjuvant therapy is allowed, if recurrence or disease progression occurs within 6 months (180 days) after neoadjuvant or adjuvant therapy, it is considered as failure of first-line standard treatment; 7. Performance status score (ECOG PS score): 0-1; 8. Expected survival =3 months; 9. Good major organ function, and relevant test indicators meet the following requirements within 14 days before enrollment: (1) Hemoglobin =90 g/L; (2) Neutrophil count >1.5×109/L; (3) Platelet count =100×109/L; (4) Total bilirubin =1.5×ULN (upper limit of normal); (5) Serum glutamic-pyruvic transaminase (ALT) or serum glutamic-oxaloacetic transaminase (AST) =2.5×ULN; if liver metastasis is present, then ALT or AST=5×ULN; (6) Serum creatinine (Cr) =1.5×ULN or creatinine clearance (Ccr) =60 ml/min; (7) Echocardiogram assessment: Left ventricular ejection fraction (LVEF) =50%; (8) Weight at least 40 kg (inclusive), or BMI>18.5; 10. Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days before enrollment and must agree to use effective contraception during the study and for at least 180 days after the last dose of medication. 11. Males who are not sterilized must agree to use effective contraception during the study and for at least 180 days after the last dose of medication.
Exclusion criteria
Exclusion criteria: Participants who meet any of the following criteria must be excluded from this study plan: 1. Previous use of other anti-angiogenic small molecule TKI drugs, such as fruquintinib, anlotinib, regorafenib, etc.; 2. Previous use of anti-PD-1 or anti-PD-L1/L2 antibodies or anti-cytotoxic T lymphocyte-associated antigen (CTLA-4) antibodies; 3. Pregnant or breastfeeding women; 4. Patients who have previously participated in other clinical trials and have not yet terminated the trials; 5. Participants with a risk of gastrointestinal bleeding cannot be enrolled, such as those with active peptic ulcer lesions, bleeding, or any other conditions that may lead to gastrointestinal bleeding or perforation according to the investigator's judgment; 6. Patients with any severe and/or uncontrolled diseases, including: (1) Patients with poorly controlled blood pressure (systolic blood pressure =150 mmHg, diastolic blood pressure =100 mmHg); (2) Patients with grade I or above myocardial ischemia or myocardial infarction, arrhythmias (including QTc=480ms), and grade =2 congestive heart failure (New York Heart Association (NYHA) classification); (3) Active or uncontrolled severe infections (=CTC AE grade 2 infections); (4) Cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis requiring antiviral treatment; (5) Renal failure requiring hemodialysis or peritoneal dialysis; (6) Two consecutive routine urine tests indicating urinary protein =++, and confirmed 24-hour urinary protein quantification >1.0 g; (7) Patients with mental diseases, including epilepsy, dementia, severe depression, mania, etc. 7. Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days before grouping (specifically combined with clinical assessment); 8. Any history of active autoimmune diseases or autoimmune diseases, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, pituitary inflammation, vasculitis, systemic lupus erythematosus, etc.; 9. Imaging shows that the tumor has invaded the surrounding of important blood vessels or the investigator judges that the tumor is highly likely to invade important blood vessels during the subsequent study period, causing fatal massive bleeding; 10. Patients with any signs or history of bleeding diathesis, regardless of severity; patients with any bleeding or bleeding events =CTCAE grade 3 within 4 weeks before enrollment, with unhealed wounds, ulcers, or fractures; 11. Arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism; 12. Patients with a history of substance abuse and inability to quit or with mental disorders; 13. Patients with a severe allergy history or allergic constitution; 14. Any disease or condition that affects drug absorption, or inability to orally take study medication; 15. Other situations deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival(OS);Disease control rate(DCR);Objective response rate(ORR);Safety;Molecular markers for efficacy prediction; | — |
Countries
China
Contacts
Public ContactHua Xie
Xuancheng People's Hospital
Outcome results
None listed