CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFudan University
About this trial
TORCH-iTNT is a prospective, multicentre, randomized phase II trial. 198 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with total neoadjuvant therapy (TNT) and assigned to Group A and Group B (1:1). Group A receives 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Group B receives SCRT (25Gy/5Fx) followed by 6 cycles of ToriCAPOX. TME surgery is scheduled after TNT while a watch and wait (W\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, organ or anal preservation rate, 3-year DFS rate, etc.
Eligibility criteria
Qualifiers
Age 18-70 years old, female and male;
Pathological confirmed adenocarcinoma;
The distance from anal verge ≤ 10 cm;
MSI/MMR status: MSS/pMMR;
Disqualifiers
Pregnancy or breast-feeding women;
Known history of other malignancies within 5 years;
Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);
Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;
Trial design
Treatments tested in this trial
- PD-1 inhibitor
- Capecitabine
- Short-course radiotherapy
- Oxaliplatin
Treatment groups
192 Participants
are divided into 2 treatment groupsLocations
1Fudan University Shanghai Cancer Center Shanghai China
Sponsors and collaborators
Fudan University
Lead sponsor
Source ClinicalTrials.gov