Rectal cancer
Conditions
Interventions
Treatment group:Oxaliplatin 130mg/m^2 d1 + capecitabine 1000mg/m^2 bid D1-14 + PD-1 monoclonal antibody (toripalimab) 240mg d1 + cetuximab 500mg/m^2, repeated every 3 weeks.
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 70 years old, gender not limited. 2. Pathologically confirmed as rectal adenocarcinoma. 3. Distance from the anus =70. 7. No chemotherapy or any other anti-tumor treatment was received before inclusion. 8. No prior immunotherapy was received before selection. 9. Be able to abide by the plan during the research period. 10. Sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women 2. Those with a history of other malignant diseases in the last five years, except for cured skin cancer and cervical carcinoma in situ 3. For patients with a history of uncontrolled epilepsy, central nervous system diseases or mental disorders, the researcher will determine that the clinical severity may prevent them from signing the informed consent form or affect their compliance with oral medication 4. Clinically severe (i.e., active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more severe congestive heart failure, or severe arrhythmia requiring drug intervention, or a history of myocardial infarction within the last 12 months 5. Those who need immunosuppressive therapy for organ transplantation and those who have been using hormone therapy for a long time 6. Patients with autoimmune diseases 7. Severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases 8. The baseline blood routine and biochemical indicators of the subjects did not meet the following criteria: hemoglobin >=90g/L; The absolute neutrophil count (ANC) is >=1.5×10^9/L; Platelet count >=100×10^9/L; ALT and AST=2.5 times the normal upper limit value; ALP =30g/L 10. Those who are allergic to any component of the research drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of anal preservation;2-year progression free survival rate;2-year local recurrence free survival rate;2-year overall survival rate;Overall survival; | — |
Countries
China
Contacts
Public ContactJiang Xin
The First Hospital of Jilin University
Outcome results
None listed