SCRT Based iTNT vs. LCRT Based TNT for MSS Locally Advanced Rectal Cancer (NCT07551479) | Clinical Trial Compass
Not Yet RecruitingPhase 3
SCRT Based iTNT vs. LCRT Based TNT for MSS Locally Advanced Rectal Cancer
China612 participantsStarted 2026-05-01
Plain-language summary
In this prospective, multicentre, randomized phase III trial, 612 locally advanced rectal cancer (LARC, T3-4/N+M0) patients with at least one high-risk features (lower location (≤5cm), cT4, cN2, MRF+, EMVI+, TD+) will be included, and randomly assigned to TNT group and iTNT group (1:1). TNT group receives long-course chemoradiotherapy (50Gy/25Fx concurrent with oral capecitabine) followed by 6 cycles of CAPOX. iTNT group receives short-course radiotherapy (25Gy/5Fx) followed by 6 cycles of Serplulimab combined with CAPOX. After the efficacy evaluation, the patients who achieves clinical complete response (cCR) will be managed by a watch and wait (W\&W) protocol and non-cCR patients will be recommended surgery. The primary endpoint is 3-year event-free survival rate (3yEFS%). The secondary endpoints include the complete response (CR, pathological complete response \[pCR\] plus cCR) rate, 3-year organ preservation rate, 3-year disease-free survival rate (3yDFS%), 3-year local recurrence free survival rate (3yLRFS%), 3-year distant metastasis free survival rate (3yDMFS%), 3-year overall survival rate (3yOS%), grade 3-4 acute adverse effects (AE) rate, rate of surgical complications, anal functions and quality of life, etc.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age 18-75 years old, female and male;
✓. Pathological confirmed adenocarcinoma;
✓. The distance from anal verge ≤ 10 cm;
✓. MSI/MMR status: MSS/pMMR;
✓. Clinical stage T3-4 and/or N+, without distance metastases;
✓. At least one of the following factors is present: distance from the anus ≤5 cm, cT4, cN2, positive cMRF, positive cEMVI, positive tumor deposit or positive lateral lymph node;
✓. KPS ≥ 70;
✓. No radiotherapy, chemotherapy, immunotherapy, or any other anti-tumor therapy had been administered prior to enrollment;
Exclusion criteria
✕. Pregnancy or breast-feeding women;
✕. Known history of other malignancies within 5 years;
What they're measuring
1
3 year event-free survival rate
Timeframe: From date of randomization until the date of first documented early local failure, disease progression during neoadjuvant therapy, pelvic recurrence, distant metastasis, or death, whichever came first, assessed up to 36 months.
. 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;
✕. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;
✕. Uncontrolled infection which needs systemic therapy;
✕. Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;
✕. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection;