Colorectal cancer
Conditions
Interventions
experimental group:Toripalimab combined with Cetuximab and FOLFIRI
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75 years; 2. Patients with advanced metastatic colorectal adenocarcinoma diagnosed by histopathology, or with metastasis more than 12 months after radical operation, were confirmed to be unresectable by MDT discussion; 3. Patients with left hemicolon cancer (including rectum), KRAS / NRAS / BRAF all wild type; 4. Patients with ECoG score = 3 months; 5. White blood cells >= 3.5 * 10^9 / L, neutrophils >= 1.5 * 10^9 / L, hemoglobin >= 100g / L, platelets >= 80 * 10^9 / L, serum liver enzyme in patients without liver metastasis is not higher than 2.5 times of the upper limit of normal value, serum liver enzyme in patients with liver metastasis is not higher than 5 times of the upper limit of normal value, serum bilirubin is not higher than 1.5 times of the upper limit of normal value, serum creatinine is not higher than 1.5 times of the upper limit of normal value; 6. Patients with at least one focus that can be measured by CT or MRI; 7. Patients with no history of other malignant tumors; 8. Subjects with fertility but willing to take contraceptive measures; 9. Patients who sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with hypersensitive or hypersensitive constitution, patients with autoimmune diseases and patients with organ transplantation history; 2. Patients who have received immunotherapy (anti PD1, anti PDL1), chemotherapy and targeted treatment for colorectal cancer, except for the end time of adjuvant treatment more than 6 months; 3. Patients with peritoneum metastasis, patients with 3 or more bone metastases; 4. Patients (including interferon, interleukin, thymosin, etc.) who received Chinese medicine or immunomodulator with anti-tumor indications within 2 weeks before the first administration; 5. Patients who have undergone major surgery within 4 weeks before the first treatment; 6. Patients who have used immunosuppressive drugs within 4 weeks before the first treatment, but excluding (less than 10 mg prednisone or the same dose of glucocorticoids per day, glucocorticoids for allergic reaction prevention) 7. Patients with only unmeasurable lesions, such as carcinomatous lymphangitis and diffuse liver invasion; patients without measurable lesions or lesions that cannot be evaluated; 8. Pregnant and lactating women who are fertile but refuse to take contraceptive measures; 9. Patients with central nervous system (brain or meninges) metastasis or mental disorders can not correctly express subjective symptoms; 10. Patients with important organ failure; 11. Patients with factors affecting administration, absorption, distribution, metabolism, excretion, etc., have uncontrollable seizures, physiological or pathological malnutrition, chronic diarrhea, and cachexia; 12. Patients with complete or incomplete ileus; 13. Patients with serious heart disease or history, including: recorded history of congestive heart failure, high-risk uncontrolled heart rate disorder, angina requiring drug treatment, clinically clear history of heart valve disease, serious myocardial infarction and stubborn hypertension; 14. Patients with severe uncontrollable infection; 15. Patients with alcohol and / or drug abuse or poor investigator compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| ETS;DPR;PFS;OS;security; | — |
Countries
China
Contacts
Public ContactBao Jun
Jiangsu Cancer Hospital
Outcome results
None listed