BRAF mutation-positive, microsatellite stable advanced colorectal cancer
Conditions
Interventions
Case series:Carrelizumab combined with furquetinib or regorafenib
Sponsors
Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old; 2. Colorectal cancer confirmed by histology or cytology, with measurable tumor lesions (spiral CT or MR scan >=10mm, meeting RECIST 1.1 standard); 3. The second-generation sequencing (NGS) result of the pathological tissue sample was BRAF V600E mutation and immunohistochemistry (IHC) showed that the mismatch repair status was proficient in mismatch repair (pMMR) or the gene sequencing result of MSI status was microsatellite stable (MSS); 4. Patients who have failed at least the first-line treatment; 5. ECOG PS score 0-1 points; 6. The expected survival period >=3 months; 7. If the enrolled patients have bone metastases, the patients should have no spinal cord compression; 8. The functions of vital organs meet the following requirements (excluding the use of any blood components and cell growth factors during the screening period): 1) The absolute count of neutrophils >=1.5 x 10^9/L; platelets >=100 x 10^9/L; hemoglobin >=9g/dL; 2) Thyroid-stimulating hormone (TSH) <=1 ULN (if abnormal, the T3 and T4 levels should be examined at the same time, if the T3 and T4 levels are normal, they can be included in the group); 3) Bilirubin <=1.5 ULN; ALT and AST <=5 ULN; 4) Serum creatinine <=1.5 ULN; 9. Women of childbearing age must have a negative pregnancy test (beta HCG) before starting treatment. Women and men of childbearing age (have sex with women of childbearing age) must agree to use effective contraception during treatment and 6 months after the last therapeutic dose; 10. The subject voluntarily joined the study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breastfeeding, or have fertility but refuse to take contraceptive measures; 2. Suffer from other malignant tumors within 5 years, except for fully treated cervical carcinoma in situ or skin squamous cell carcinoma, or skin basal cell carcinoma that has been basically controlled; 3. Patients with active bleeding or abnormal blood coagulation (PT > 16s, APTT > 43s, INR> 1.5 ULN), have bleeding tendency or are receiving thrombolytic therapy; 4. Have received PD-1/PD-L1 inhibitor monoclonal antibody therapy, VEGF pathway targeted therapy, EGFR pathway targeted therapy; 5. Those with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction; 6. Obvious voids or necrosis in the tumor; 7. Poor control of serous cavity effusion; 8. Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia and severely impaired lung function; 9. Subjects with active, known or suspected autoimmune diseases, hypothyroidism requiring only hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss) Can be selected 10. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months; or other patients who cannot tolerate surgery; 11. Severe active infections that require intravenous antibiotic treatment occurred during the enrollment period; 12. Those who are allergic to test drugs; 13. Live vaccines have been vaccinated or will be vaccinated within 30 days before the administration of Carrelizumab; 14. Known history of HIV infection; 15. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up; 16. The researcher believes that it is inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS;6-month OS;Safety; | — |
Countries
China
Contacts
Public ContactXiaoli Wei
Affiliated Cancer Hospital of Harbin Medical University
Outcome results
None listed