colorectal cancer
Conditions
Interventions
experimental group:Toripalimab combined with Fruquintinib
Sponsors
The First Hospital of Lanzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed colorectal cancer patients; 2. Advanced colorectal cancer with second-line and above standard chemotherapy failure; 3. The tumor tissue test was consistent with any of the following: 1)Immunohistochemical analysis of mismatch repair protein is integrated 2)NGS is detected as MSI-L or MSS 3) PCR is detected as MSI-L or MSS 4. Age >= 18 years old =3 months; 8. Patients who have not been treated with immunological checkpoint inhibitors; 9. Patients are capable of taking medicine orally; 10. The function of the main organs is normal, that is to say, the following criteria are met, (1) Blood routine examination standards should be met the following criterions (no blood transfusion and blood products was used within 14 days, no G-CSF and other hematopoietic stimulating factors was used to correct) a. HB >= 90 g/L b. ANC >= 1.0 x 10^9/L c. PLT >= 80 x 10^9/L (2) Biochemical examinations must meet the following criteria: a. Total bilirubin = 50ml/min (According to the Cockroft-Gault formula) d. Urine protein: It satisfies one of the following criteria (other tests may not be performed if any test criteria is met) (1) urine protein (test paper method) 2+ or <2+; (2) urine protein creatinine (UPC) ratio < 3.5; (3) 24-hour urine protein determination: urine peptone<=3500 mg. e. Prothrombin time (PT)-international standardized ratio (INR): <= 1.5 (INR less than 3.0 if anticoagulant therapy is received). 11. Patients voluntarily joined the study and signed the informed consent, with good compliance and follow-up. 12. Women of childbearing age should agree to take adequate barrier contraception during and within 6 months after the study.
Exclusion criteria
Exclusion criteria: 1. Patients who have been previously treated with systematic chemotherapy, radiation therapy, hormone therapy or immunotherapy in the first three weeks of enrollment. 2. Patients who have been previously treated with Fruquintinib as well as Toripalimab 3. History and complications 1) Patients with uncontrolled hypertension (systolic blood pressure >=160 mmHg, diastolic blood pressure >= 95 mmHg); 2) Patients with acute coronary syndromes (including myocardial infarction and unstable angina) and a history of coronary angioplasty or stenting within 6 months prior to screening; 3) Patients with large pleural effusion or ascites requiring drainage; 4) Patients with active infection according to the version 4.03 of NCI-CTCAE; 5) Subjects with symptomatic brain metastases; 6) Patients with complete intestinal obstruction; 7) Known history of, or any evidence of active, non-infectious pneumonitis or interstitial lung disease; 8) Clinically significant active coronary heart disease, or congestive heart failure, NYHA III-IV; 9) Active autoimmune disease; 10) Patients requiring systemic corticosteroids (not including temporary tests, prevent allergic reactions or reduce radiation - related swelling) or immunosuppressants; 11) Patients with epilepsy require medication; 12) Patients with grade 3 or higher bleeding within 3 weeks prior to enrollment; 13) Patients underwent major surgery within 3 weeks before admission, and the surgical wound has not healed or with unhealed fracture; 14) Patients with a history of studying allergy to drugs or excipients; 15) A woman who is pregnant or breastfeeding, or is likely to become pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;1-year progression-free survival;overall survival;Safety;Quality Of Life; | — |
Countries
China
Contacts
Public ContactShoucheng Ma
The First Hospital of Lanzhou University
Outcome results
None listed