colorectal cancer
Conditions
Interventions
experimental group:Darafenitumertinib plus iritiniconcetuximab
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histopathologically confirmed metastatic colorectal cancer and tumor tissue genetically tested for BRAF V600E mutation. 2. Age >= 18 years and 2 weeks. 6. At least one measurable or evaluable lesion according to RECIST V1.1. 7. Can provide archived pathological tissue or fresh pathological tissue for BRAF V600E testing and obtain test results. 9. Expected survival >= 12 weeks. 10. Female subjects of childbearing age or male subjects whose sexual partner is a female of childbearing age are required to use effective contraception throughout the treatment period and 6 months after the treatment period (see Section 4.3). 11. Sign written informed consent and be able to comply with protocol-mandated visits and related procedures.
Exclusion criteria
Exclusion criteria: 1. Endoscopic signs of active bleeding in the lesion are known. 2. Presence of intestinal obstruction. 3. Recurrent diarrhea that cannot be relieved after symptomatic treatment. 4. The burden of liver metastases accounted for more than 50% of the total liver volume. 5. Known allergy (grade 3 or higher) to any monoclonal antibody or chemotherapy drug (irinotecan) preparation component. 6. A history of acute coronary syndrome, coronary angioplasty, or stent placement within 6 months; 7. Congestive heart failure grade II or higher (New York Heart Association); 8.QTc interval >= 480 ms; 9. Uncontrolled arrhythmias; 10. History of retinal vein occlusion; 11. History of active brain metastases or known G6PD deficiency. 12. You have hypertension that is not well controlled with antihypertensive medication (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg). 13. Abnormal coagulation function (INR> 2.0, PT> 16s), have bleeding tendencies or are receiving thrombolytic or anticoagulant therapy, allowing prophylactic use of low-dose aspirin and low-molecular weight heparin. 14. Clinically significant bleeding symptoms or clear bleeding tendency occurred within 3 months before enrollment. 15. Urine routine indicated urinary protein >= ++ and confirmed 24-hour urinary protein volume & GT; 1.0 g. 16. The patient had active infection, unexplained fever >= 38.5 ? within 7 days before medication, or baseline white blood cell count & GT; 15 x 10^9 / L. 17. The patient had previously received other BRAF inhibitors or MEK inhibitors. 18. Concurrent participation in another interventional clinical study unless participating in an observational (non-interventional) clinical study or in the follow-up phase of an interventional study. 19. Receive live attenuated vaccine within 4 weeks before the first dose of study treatment or during the study period. Note: Inactivated virus vaccine for injection against seasonal influenza is permitted within 4 weeks before the first dose; But they are not allowed to receive live attenuated influenza vaccines; 20. Had undergone a major surgical procedure (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the initial dose of study treatment or was expected to require major surgery during the study treatment. 21. Clinically uncontrollable malignant hydrothorax and ascites. 22. Patients with bone metastases at risk for paraplegia. 23. A known history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positivity). 24. Severe infections that are active or poorly controlled clinically. 25. Significant malnutrition, such as the need for intravenous nutrient supplementation; Malnutrition was not corrected for more than 4 weeks before the first dose of study treatment. 26. Known to have acute or chronic active hepatitis B (HBsAg positive with HBV DNA viral load >= 200 IU/mL or >= 10^3 copies /mL) or acute or chronic active hepatitis C (HCV antibody positive with HCV RNA positive). 27 had a history of gastrointestinal perforation and/or fistula within 6 months prior to study enrollment. 28. History of other primary malignancies, except malignancies that had a complete remission for at least 2 years before enrollment and did not require additional treatment during the study; Non-melanoma skin cancer or malignant freckle with adequate treatment and no evidence of disease recurrence; Adequately treated carcinoma in situ with no evidence of disease recurrence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose; | — |
Countries
China
Contacts
Public ContactBin Liu
Sichuan Cancer Hospital
Outcome results
None listed