Rectal Cancer
Conditions
Interventions
1:Fruquintinib + toripolimab + CRT
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Rectal adenocarcinoma was confirmed pathologically; 2. Baseline clinical staging was T3-4 and/or N+, and rectal enhanced MRI was recommended as staging standard; 3. Distance from anus = 80g/L, absolute value of neutrophil (ANC) >= 1.5 x 10^9/L, absolute value of lymphocytes >= the lower limit of normal value, platelet (PLT) >= 80 x 10^9/L; (2) Biochemical tests should meet the following criteria: Total bilirubin (TBIL) <= 1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 x ULN; (3) Coagulation tests should meet the following standards: International standardized ratio (INR) or prothrombin time (PT) <= 1.5 ULN; Activated partial thrombin time (APTT) <= 1.5 ULN (if the patient is on anticoagulant therapy, as long as PT and APTT are within the expected treatment range); (4) Thyroid function: T3 and T4 levels were normal after drug treatment; 9. No history of autoimmune diseases or current autoimmune diseases; 10. Subjects must give informed consent to the study prior to the study and have voluntarily signed a written informed consent; 11. The subjects can communicate well with the researcher and complete the study according to the protocol; 12. Women of reproductive age 12 should agree to use contraception (such as an intrauterine device, birth control pill or condom) during the study period and 120 days after the end of the study; Serum or urine pregnancy tests were negative during the 7 days prior to study enrollment.
Exclusion criteria
Exclusion criteria: 1. Those who have received previous treatment with immune checkpoint inhibitors; 2. Known allergic reactions to PD-1 inhibitors, TKI inhibitor-related ingredients or any excipients; 3. Patients with combined viscera bleeding or bleeding tendency, except for rectal bleeding in the primary foci (researchers need to evaluate the risk of massive bleeding; 4. Pregnant or nursing women; 5. Basal cell carcinoma of the skin, carcinoma in situ of the cervix and thyroid carcinoma that have been cured within 5 years or at the same time; 6. Patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder whose clinical severity, as judged by the investigator, may hinder the signing of informed consent or affect the patient's compliance with oral medication; 7. Clinically severe (i.e., active) heart disease, such as symptomatic coronary heart disease, NYHA class II or worse congestive heart failure or severe arrhythmia requiring medical intervention, or a history of myocardial infarction within the last 12 months; 8. Subjects (including organ transplant recipients) requiring systemic treatment with corticosteroids (more than 10mg of prednisone equivalent daily) or other immunosuppressants within 2 weeks prior to initial use of the study drug; 9. Participate in clinical trials of other interventional drugs within 4 weeks before the first administration; 10. Major surgery or severe trauma within 4 weeks prior to initial use of the study drug; 11. Severe infection (CTCAE greater than grade 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, and complications of infection requiring hospitalization; Baseline chest imaging suggests active lung inflammation, signs and symptoms of infection within 2 weeks prior to initial use of the study drug, or the need for oral or intravenous antibiotic therapy (excluding prophylactic use of antibiotics); 12. Have active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes); Autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone, and type 1 diabetes treated with stable doses of insulin can be included; Patients with vitiligo or recovered childhood asthma/allergies who do not need any intervention as adults are excluded. 13. Have a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or have a history of organ and bone marrow transplants; 14. Patients found to have active pulmonary tuberculosis infection through medical history or CT examination, or patients with active pulmonary tuberculosis infection history within 1 year prior to enrollment, or patients with active pulmonary tuberculosis infection history before 1 year without formal treatment; 15. subjects had active hepatitis (HBV DNA >= 2000IU/mL or 10000 copies/mL), hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the detection limit of analysis method); 16. Known history of psychotropic drug abuse, alcoholism and drug abuse; 17. Have medical history, illness, treatment, or abnormal laboratory results that may interfere with the results of the study or prevent the subjects from participating fully in the study, or the investigator believes that study participation is
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;1 year disease free survival rate;1 year overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Objective response rate; | — |
Countries
China
Contacts
Public ContactZhiping Li
West China Hospital, Sichuan University
Outcome results
None listed