metastatic colorectal cancer
Conditions
Interventions
experimental group:Adbelimumab+famitinib malate+chemotherapy
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. =18 years of age, gender not limited; 2. Subjects with pathologically confirmed metastatic colorectal adenocarcinoma (all other histological types excluded); 3. Prior failure of first-line standard chemotherapy. 4. Subject had at least one measurable target lesion according to RECIST 1.1 criteria; 5. ECOG score: 0 ~ 1; 6. The expected survival period for 3 months or more; 7. Good main organ function, that is, the relevant examination indicators within 14 days before enrollment meet the following requirements: (1) blood routine examination (no blood transfusion, no use of white blood cell and platelet raising drugs within 14 days before screening) : hemoglobin > 90 g/L; Neutrophil count > 1.5×109/L; The platelet count > 100 x 109 / L; (2) Biochemical examination: total bilirubin = 1.5×ULN (upper limit of normal value); Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2×ULN; If there was liver metastasis, ALT and AST = 5×ULN; The endogenous creatinine clearance or 60 ml/min (Cockcroft - Gault formula); (3) Echocardiography: Left ventricular ejection fraction (LVEF) = 50%; 8. If you have hepatitis B virus (HBV) infection, if HBsAg is positive, HBV-DNA should be tested, and HBV-DNA should be <2000 IU/mL (<104 copy/mL if the research center has only copy/mL testing unit); Participants with HBV-DNA=2000 IU/mL received antiviral therapy (only nucleoside drugs such as entecavir, tenofovir dipivoxil fumarate, and tenofovir propofol fumarate tablets) for at least 1 week before the first dose and had a viral copy number decrease of more than 10-fold (1 lg) from the baseline. For HBV infection, need to accept the antiviral treatment during the whole research. Hepatitis C virus (HCV) -RNA positive subjects must receive antiviral therapy according to treatment guidelines. 9. Women of childbearing age must be within three days of pregnancy in the first drug testing for (beta HCG) negative. Women of reproductive age and men (who have sex with a woman of reproductive age) must agree to contraception during treatment and for 6 months after the last dose;
Exclusion criteria
Exclusion criteria: 1. In the past or at the same time with other malignant tumours, but has been cured except skin basal cell carcinoma and cervical carcinoma in situ; 2. Always received VEGFR class small molecule tyrosine kinase inhibitors (e.g., rice for Nepal, sorafenib, chougny, rui GeFei, etc.) for treatment of the subjects; 3. Subjects previously treated with ICS (e.g., PD-1/PD-L1 inhibitors, CTLA-4 inhibitors); 4. Participated in other drug clinical trials within four weeks; 5. Patients who have not recovered from other treatments, in which the interval between receiving nitroso or mitomycin and taking the study drug was 6 weeks or more; Received other cytotoxic drugs, targeted drugs, radiotherapy or surgery for more than 4 weeks, and the wound has been completely healed. Receiving Chinese patent medicine or Chinese medicine for =2 weeks; 6. Multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 7. Patients with a history of bleeding, with any bleeding event of CTCAE 5.0 grade 3 or higher within 4 weeks before screening; 8. Subjects with known CNS metastases prior to screening or a history of CNS metastases were screened. Subjects with clinically suspected central nervous system metastases had to undergo contrast-enhanced CT or Magnetic Resonance Imaging (MRI) within 28 days before enrollment to exclude central nervous system metastases. 9. Patients with hypertension not well controlled by single antihypertensive medication (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); Patients with a history of unstable angina; 3 months prior to screening new diagnosis of angina pectoris or myocardial infarction incident within 6 months prior to screening; Arrhythmias (including QTcF = 450 ms in men and = 470 ms in women) required long-term use of antiarrhythmic drugs and New York Heart Association (NYHA) grade = II cardiac dysfunction. 10. Urine routine showed urine protein = ++ and confirmed 24-hour urine protein quantitation >1.0 g; 11. Active infection, fever of unknown origin = 38.5? within 7 days before the first dose, or white blood cell count > 15×109/L at baseline; 12. Previous or current interstitial pneumonia/interstitial lung disease requiring systemic glucocorticoid therapy; There are currently active pneumonia or pulmonary function tests confirmed severely impaired lung function; 13. Not for a long time to heal the wounds or incomplete healing of fracture. 14. Imaging shows that the tumor has invaded the important blood vessels or the investigator judges that the subject's tumor has a high probability of invading the important blood vessels during the treatment and causing fatal hemorrhage; 15. Patients with abnormal coagulation function and bleeding tendency (INR within the normal range without using anticoagulants must be met within 14 days before enrollment); Subjects treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; Low-dose warfarin (1 mg orally once daily) or low-dose aspirin (at a dose of up to 100 mg daily) for preventive purposes were allowed if the International Normalized Ratio of prothrombin time (INR) was 1.5 or less. 16. Arterial/venous thrombosis events occurred within one year before screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except for venous thrombosis caused by venous catheterization due to previous chemotherapy and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Overall survival;Duration of Response;Progressives free survival; | — |
Countries
China
Contacts
Public ContactHe Yifu
Anhui Provincial Hospital
Outcome results
None listed