Advanced colorectal cancer with RAS/BRAF mutation
Conditions
Interventions
Experimental Group:TAS-102 combined with bevacizumab
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients with colorectal cancer confirmed by histopathology, with distant metastasis and RAS or BRAF mutations, who have not had disease progression after 8-12 cycles (4-6 months) of first-line FOLFOX/FOLFIRI combined with bevacizumab treatment. Not suitable for surgery after treatment; 2.Age: >=18 years old, gender is not limited; 3.ECOG performance status score 0-1; 4.With adequate organ and bone marrow function, adverse reactions after induction therapy have recovered to grade 1 or normal; 5.Signed informed consent before commencing study-specific screening procedures; 6.The expected survival period is more than 3 months; 7.Patients of childbearing potential must take effective medical contraceptive measures (for both male and female subjects, until 90 days after the last study administration);
Exclusion criteria
Exclusion criteria: 1.In addition to chemotherapy combined with bevacizumab induction therapy, patients have previously received chemotherapy, radiotherapy, immunotherapy, anti-angiogenesis targeted therapy, and other research treatment drugs for colorectal cancer (excluding neoadjuvant and adjuvant chemoradiotherapy); 2.Patients who have received other anti-tumor treatments (including traditional Chinese medicine with anti-tumor effects) after chemotherapy combined with bevacizumab induction therapy; 3.Severe adverse reactions during first-line treatment lead to inability to continue treatment; 4.Patients choose surgery after induction therapy for metastatic colorectal cancer; 5.Pregnant or breastfeeding women; 6.History of other malignancies other than colorectal cancer in the past 5 years, excluding basal cell carcinoma of the skin, carcinoma in situ of the cervix, or early thyroid cancer; 7.Uncontrolled pleural effusion, pericardial effusion, or ascites; 8.Clinically significant cardiovascular disease, such as heart failure, coronary artery disease, cardiomyopathy, arrhythmia, uncontrolled hypertension, history of myocardial infarction within the past 5 years, left ventricular ejection on baseline MUGA or Doppler echocardiography Scores below the normal range, etc.; 9.severe uncontrolled concurrent infection or other severe uncontrolled concomitant diseases, moderate or severe renal impairment; 10.History of acute or subacute intestinal obstruction, or inflammatory bowel disease; 11.Underwent major surgery within 4 weeks before the first treatment; 12.Allergic reaction to the drugs used in this study; 13.History of active autoimmune disease or primary immunodeficiency; 14.Known to have active pulmonary tuberculosis; 15.known HIV infection or syphilis infection or active hepatitis B or C; 16.Other circumstances where the researcher believes that the patients cannot be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 12-month OS rate;Overall Survival, OS;Safety; | — |
Countries
China
Contacts
Public ContactYongdong Jin
Sichuan Cancer Hospital
Outcome results
None listed