colorectal cancer
Conditions
Interventions
experimental group:fruquintinib and cetuximab
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Advanced colorectal adenocarcinoma was diagnosed histologically or cytologically with measurable lesions outside the intestine (helical CT scan >= 10mm, RECIST 1.1 criteria); (2) Aged >= 18 years; (3) ECOG/PS score 0-2; (4) NRAS, KRAS and BRAF of histological gene detection were wild-type; (5) Patients with resistance or intolerance to second-line treatment ; (6) Expected survival >= 3 months; (7) Normal organ function : normal bone marrow function includes: absolute neutrophil count(ANC) >= 1.5 x 10^9/L, platelet (PLT) >= 80 x 10^9/L, and hemoglobin (HB) >= 90g/L;Normal renal function: serum creatinine (Cr) = 60ml/min;Normal liver function: total serum bilirubin (TBIL) <= 1.5 times the upper limit of normal (ULN), serum AST/ALT <= 2.5 times ULN, and AST/ALT <= 5 times ULN if the abnormal liver function is caused by a potential malignant tumor. (8) The patients voluntarily joined the study, signed the informed consent form, good compliance, and cooperated with the follow-up. (9) Women in childbearing age must undergo a negative pregnancy test (serum or urine) within 7 days of enrollment and voluntarily use an appropriate method of contraception during observation and within 8 weeks after the last administration.
Exclusion criteria
Exclusion criteria: (1) Regafenib, furoquinitinib and other small molecule tyrosine kinase inhibitors (apatinib, antininib, etc.) have been previously applied; (2) PFS time less than 2 months of patients in first-line and second-line cetuximab treatment, (3) Patients with central nervous system metastasis or other malignant tumors within 5 years; (4) Patients with active tuberculosis, other serious diseases and other uncontrolled infections, severe electrolyte disturbance, obvious bleeding tendency or active bleeding; (5) A history of autoimmune diseases, hematological system diseases and organ transplantation, or long-term use of hormones or immunosuppressive drugs; (6) Patients prepare to receive radiotherapy; (7) Patients with depression, mania, obsessive-compulsive disorder and schizophrenia; (8) Those who have participated in other clinical trials in the past 4 weeks; (9) Pregnant or lactating women. (10) Severe or uncontrolled hypertension. (11) Those who are considered inappropriate by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;grade 3/4 incidence of adverse side;dose-limiting toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;progression-free survival; | — |
Countries
China
Contacts
Public ContactHaibo Zhang
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed