colorectal cancer
Conditions
Interventions
treatment group:fruquintinib plus candonilimab
Sponsors
Nanjing Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. All other histological types were excluded in patients with pathologically or cytologically confirmed adenocarcinoma of the colon or rectum; 3. Receiving at least two lines of standard therapy with imaging evidence of disease progression; For neoadjuvant or adjuvant therapy (chemotherapy or chemoradiotherapy), if disease progression occurs during treatment or within 6 months after discontinuation of treatment, it should be counted as first-line therapy (as assessed by investigators according to RECIST1.1); 4. ECOG score: 0-1; 5. At least one lesion detectable by CT, according to RECIST 1.1; 6. Expect to survive for at least 3 months; 7. Major organ function within 7 days before treatment meets the following criteria: (1) Hemoglobin (HB) >= 90 g/L; (2) Absolute neutrophil ANC >= 1.5 x 10^9/L; (3) Platelet (PLT) >= 100 x 10^9/L; 8. Biochemical tests shall meet the following standards: (1) Total bilirubin (TBIL) = 60 mL/min; 9. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= the lower limit of normal (50%); 10. Patients of childbearing age (including female and female partners of male patients) must take effective birth control measures; 11. The subjects volunteered to participate in the study and signed the ICF; 12. Good compliance is expected, and the efficacy and adverse reactions can be followed up according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients previously treated with candonilimab; 2. Previous use of anti-PD-1 or anti-PD-L1 /L2 antibody or anti-cytotoxic T-lymphocyte-associated antigen (CTLA-4) antibody; 3. Previous use of other anti-angiogenic small molecule TKI drugs, such as anlotinib, apatinib, sorafenib, regorafenib, etc.; 4. MSI-H/dMMR patients confirmed by immunohistochemistry and/or PCR and NGS; 5. Pregnant or lactating women; 6. Patients who have participated in other clinical trials and have not terminated the trials; 7. Subjects at risk for gastrointestinal bleeding were excluded if they had active digestive ulcer lesions, with bleeding, or any other condition that could lead to gastrointestinal bleeding or perforation in the investigator's judgment; 8. Patients with any severe and/or uncontrolled disease, including: (1) Patients with poor blood pressure control (systolic blood pressure =150 mmHg, diastolic blood pressure >= 100 mmHg); (2) Patients with grade I or higher myocardial ischemia or infarction, arrhythmias (including QTc >= 480ms), or congestive heart failure grade 2 (New York Heart Association (NYHA) classification); (3) Active or uncontrolled severe infection ( >= CTC AE grade 2 infection); (4) Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis need antiviral therapy; (5) Renal failure requiring hemodialysis or peritoneal dialysis; (6) Two consecutive routine urine tests indicated urinary protein =++, and confirmed 24-hour urinary protein quantification > 1.0 g; (7) Suffer from mental illness, including epilepsy, dementia, severe depression, mania, etc.; 9. Receiving major surgical treatment, open biopsy or obvious traumatic injury within 28 days before grouping (combined with clinical evaluation); 10. Any history of active autoimmune disease or autoimmune disease, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, pituitary inflammation, vasculitis, systemic lupus erythematosus, etc.; 11. Patients whose imaging showed that the tumor had invaded the periphery of important blood vessels or who were judged by the investigator to be highly likely to invade important blood vessels during the subsequent study and cause fatal massive bleeding; 12. Patients with any evidence of bleeding constitution or history, regardless of severity; Unhealed wounds, ulcers, or fractures were present in patients with any bleeding or bleeding events >= CTCAE grade 3 within 4 weeks before enrollment; 13. 6 months have experienced an arteriovenous thrombotic event, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism; 14. Those who have a history of psychotropic drug abuse and are unable to quit or have mental disorders; 15. Patients with a history of severe allergy or allergic constitution; 16. Any disease or condition that affects the absorption of the drug, or the inability to take the study drug orally; 17. Other conditions deemed inappropriate for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;Safety; | — |
Countries
China
Contacts
Public ContactMin Li
Nanjing Hospital of Traditional Chinese Medicine
Outcome results
None listed