Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: NCT06281405

Reclutando

TORCH-iTNT: CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer

Intervencionista

Fase 2

Fudan University Shanghai Cancer Center

Patrocinador: Fudan University

Última actualización: 3 de abril de 2026
Aviso: La información proviene de registros públicos y puede no reflejar cambios en tiempo real en el centro local.

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.

Categoría de tratamiento

Quimioterapia, Radioterapia, Otros medicamentos

Erforderliche Mutationen

Ninguna

Ensayo iniciado

28 de marzo de 2024

Última actualización por el patrocinador

3 de abril de 2026

Finalización estimada

30 de junio de 2026

Contacto del estudio

Nombre:Zhen Zhang, MD

Correo electrónico:zhen_zhang@fudan.edu.cn

Teléfono:18801735029

Nombre:Yaqi Wang, MD

Correo electrónico:10301010093@fudan.edu.cn

Teléfono:18121299593

Elegibilidad

Criterios de inclusión

1. Age 18-70 years old, female and male;

2. Pathological confirmed adenocarcinoma;

3. The distance from anal verge ≤ 10 cm;

4. MSI/MMR status: MSS/pMMR;

5. Clinical stage T3-4 and/or N+, without distance metastases;

6. At least one of the following factors is present: distance from the anus ≤5 cm, cT4, cN2, positive cMRF, positive cEMVI, or positive lateral lymph nodes;

7. KPS ≥ 70;

8. No radiotherapy, chemotherapy, immunotherapy, or any other anti-tumor therapy had been administered prior to enrollment;

9. Baseline blood and biochemical indicators meet the following criteria: neutrophils ≥ 1.5 × 10^9/L, Hb ≥ 90 g/L, PLT ≥ 100 × 10^9/L, ALT/ AST ≤ 2.5 ULN, Cr ≤ 1 ULN;

10. With good compliance and signed the consent form.

Criterios de exclusión

1. Pregnancy or breast-feeding women;

2. Known history of other malignancies within 5 years;

3. Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);

4. Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;

5. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;

6. Uncontrolled infection which needs systemic therapy;

7. Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;

8. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection;

9. Allergic to any component of the therapy.

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Detalles del diseño

AsignaciónRandomized

Modelo de intervenciónParallel Assignment

EnmascaramientoNone (Open Label)

Número a inscribir192

Brazos e Intervenciones

Brazos

Intervenciones

Tipo: Experimental

Descripción: The patients will receive 6 cycles of CAPOX and PD-1 antibody. TME surgery is scheduled after TNT while a W&W option can be applied to patients achieving cCR.

Intervenciones:

Capecitabine
Short-course radiotherapy
PD-1 inhibitor
Oxaliplatin

Medidas de resultado

Medidas de resultado primarias

Complete response (CR) rate1 month after the surgery or the decision of W&W

Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W&W strategy.

Medidas de resultado secundarias

3 year disease free survival rateFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.

Rate of 3 year disease free survival

3 year local recurrence free survival rateFrom date of randomization until the date of first documented pelvic failure, assessed up to 36 months.

Rate of 3 year local recurrence free survival

3 year overall survival rateFrom date of randomization until the date of death from any cause, assessed up to 36 months.

Rate of 3 year overall survival

Grade 3-4 adverse effects rateFrom date of randomization until 3 months after the completion neoadjuvant therapy

Rate of chemotherapy, radiotherapy and immunotherapy related adverse events

Rate of surgical complicationsThe surgical complications were assessed within 3 months after the surgery.

Rate of surgical complications, such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.

3 year organ or anal preservation rateFrom date of randomization until the resection of rectum or anus, assessed up to 36 months.

3 year organ or anal preservation rate

3 year distant metastasis free survival rateFrom date of randomization until the date of first documented distant metastasis, assessed up to 36 months.

Rate of 3 year distant metastasis free survival

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Sitios del ensayo

Este estudio tiene 1 sitio de ensayo

Fudan University Shanghai Cancer Center

Shanghai, CN

Nombre:Zhen Zhang, MD, PHD

Correo electrónico:zhen_zhang@fudan.edu.cn

Teléfono:18801735029

Reclutando

Shanghai, CN

Fudan University Shanghai Cancer Center

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