Colorectal cancer
Conditions
Interventions
Test group:Camrelizumab + Fruquintinib
Sponsors
Anhui Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with advanced colon or rectal adenocarcinoma diagnosed by pathology; MSS or pMMR; 2. At least and can only receive 2 standard regimens of treatment after recurrence or metastasis; 3. Voluntarily sign the informed consent form, understand the study and be willing to follow and have the ability to complete all experimental procedures; 4. Men and women are not limited, and aged 18 to 70 years (including the boundary value); 5. Patients with a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) score; 6. Expected to survive for at least 3 months; 7. According to the evaluation criteria for solid tumors (RECIST v1.1), subjects must have measurable lesions (at least 1 extracranial lesion); 8. Asymptomatic central nervous system (Central Nervous System, CNS) metastases, or patients with asymptomatic brain metastases after treatment, Must be free of disease progression on computed tomography (CT) or magnetic resonance imaging (MRI), stable for at least 3 months, and for at least 4 weeks No need for steroid treatment; 9. The laboratory test results within two weeks before enrollment meet the following conditions: (1) Absolute neutrophil count (ANC) >= 1.5x10^9/L; (2) Absolute white blood cell count (WBC) >= 3.0x10^9/L; (3) Platelets>=100x10^9/L; (4) Hemoglobin>=90g/L; (5) Serum creatinine <= 1.5 times the upper limit of normal (ULN); (6) AST and ALT <= 2.5 times ULN, patients with liver metastases <= 5 times ULN; (7) Serum total bilirubin (TBIL) <= 1.5 ULN; (8) International normalized ratio (INR) <= 2 ULN, or activated partial thromboplastin (APPT) <= 1.5 ULN (except for patients receiving anticoagulant therapy); (9) Male subjects and female subjects of childbearing age should agree to take effective contraceptive measures from the signing of the informed letter until 3 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Those suffering from other malignant tumors within 5 years before enrollment, except for cured cervical carcinoma in situ and cured basal cell carcinoma of the skin; 2. The adverse effects of previous treatments failed to recover to CTCAE v5.0 grade score 10 mg prednisone/day) or other immunosuppressive drugs within 14 days before the first administration or during the study period; the following conditions are allowed to be included in the group; 10. Allow subjects to use topical or inhaled corticosteroids 11. Allow short-term (<=7 days) use of glucocorticoids to prevent or treat non-autoimmune allergic diseases; 12. Patients with active gastrointestinal ulcer, incomplete intestinal obstruction, active gastrointestinal bleeding, or perforation; 13. Currently suffering from interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease, radiation pneumonia; 14. Uncontrolled and stable systemic diseases after treatment, such as cardiovascular and cerebrovascular diseases, diabetes, hypertension, tuberculosis, etc.; 15. Have a history of infection with human immunodeficiency virus, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation, or a history of stem cell transplantation; 16. Patients with active chronic hepatitis B or active hepatitis C. Carriers of hepatitis B virus, stable hepatitis B (DNA titer not higher than 500 IU/mL or copy number <1000 copies/ml) after drug treatment, and cured hepatitis C patients (with negative HCV RNA test) can be included in the group; 17. Patients with severe infections within 4 weeks before the first administration, or patients with active infections within the first 2 weeks that require oral or intravenous antibiotic treatment; 18. Subjects who are known to have had severe allergic reactions to macromolecular protein preparations/monoclonal antibodies, or to any test drug component (CTCAE v5.0 grade greater than 3); 19. Participated in other drug clinical trials within 4 weeks before the first administration (subject to the trial drug used) 20. Alcohol dependence or a history of drug abuse or drug abuse within the past year; 21. Those who have a clear history of neurological or mental disorders, such as epilepsy, dementia, poor compliance, or peripheral nervous system disorders;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Countries
China
Contacts
Public ContactHe Yifu
Anhui Cancer Hospital
Outcome results
None listed