Locally advanced rectal cancer
Conditions
Interventions
Long-term Chemoradiotherapy Group (TNT Control Group):Long-term radiotherapy (50Gy/25Fx) with concurrent capecitabine sensitization, followed by CAPOX chemotherapy for 6 cycles 2 weeks after radiother
Short-term Chemoradioimmunotherapy Group (iTNT Experimental Group):Short-term radiotherapy (25Gy/5Fx), followed by CAPOX plus PD-1 monoclonal antibody (sulirumab 300mg) chemoradioimmunotherapy for 6 c
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–75 years old, female and male; 2. Pathological confirmed adenocarcinoma; 3. The distance from anal verge = 70; 8. No radiotherapy, chemotherapy, immunotherapy, or any other anti-tumor therapy had been administered prior to enrollment; 9. With good compliance during the study; 10. Signed written informed consent;
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breast-feeding women; 2. Known history of other malignancies within 5 years, except cured skin cancer and cervical cancer in situ; 3. Individuals with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders that, in the judgment of the investigator, are of such clinical severity that they may prevent the signing of an informed consent form or affect the patient's adherence to oral medications; 4. Individuals with clinically serious (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months; 5. Individuals with a history of organ transplantation requiring immunosuppressive therapy and long-term hormone therapy; 6. Individuals with autoimmune diseases; 7. Individuals with severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases; 8. Baseline hematology and biochemistry did not meet the following criteria: Hb>=90g/L; NEU >=1.5×10^9/L; PLT >=100×10^9/L; ALT, AST =30g/L; 9. Individuals with dihydropyrimidine dehydrogenase (DPD) deficiency; 10. Individuals allergic to any drug component of the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year Event-Free Survival Rate (3yEFS%); | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Response (CR) Rate;3-year Organ Preservation Rate (3yOP%);3-year Overall Survival Rate (3yOS%);3-year Disease-Free Survival Rate (3yDFS%);3-year Distant Metastasis-Free Survival Rate (3yDMFS%);3-year Local Recurrence-Free Survival Rate (3yLRFS%);Safety Outcomes (including Grade =3 toxicities, surgical complication rate, quality of life score, anal function score); | — |
Countries
China
Contacts
Public ContactZhang Zhen
Fudan University Shanghai Cancer Center
Outcome results
None listed