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

NCT ID: NCT06281405

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2028-12-31

Brief Summary

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, anal preservation rate, 3-year DFS rate, etc.

Conditions

Locally Advanced Rectal Cancer; Neoadjuvant Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immunochemotherapy group

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.

Group Type: EXPERIMENTAL

PD-1 antibody

Intervention Type: DRUG

PD-1 antibody (Toripalimab): 240mg d1 q3w

Capecitabine

Intervention Type: DRUG

Capecitabine: 1000mg/m2 bid d1-14 q3w

Radiation plus immunochemotherapy group

The patients will receive short-course radiotherapy (25Gy/5Fx), followed by 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.

Group Type: EXPERIMENTAL

PD-1 antibody

Intervention Type: DRUG

PD-1 antibody (Toripalimab): 240mg d1 q3w

Capecitabine

Intervention Type: DRUG

Capecitabine: 1000mg/m2 bid d1-14 q3w

Short-course radiotherapy

Intervention Type: RADIATION

Short-course radiotherapy: 25Gy/5Fx

Interventions

PD-1 antibody

PD-1 antibody (Toripalimab): 240mg d1 q3w

Intervention Type: DRUG

Capecitabine

Capecitabine: 1000mg/m2 bid d1-14 q3w

Intervention Type: DRUG

Short-course radiotherapy

Short-course radiotherapy: 25Gy/5Fx

Intervention Type: RADIATION

Other Intervention Names

Toripalimab

Eligibility Criteria

Inclusion Criteria

1. Pathological confirmed adenocarcinoma;

2. Clinical stage T3-4 and/or N+;

3. The distance from anal verge ≤ 12 cm;

4. Without distance metastases;

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

6. KPS ≥ 70;

7. 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;

8. With good compliance and signed the consent form.

Exclusion Criteria

1. Pregnancy or breast-feeding women;

2. Known history of other malignancies within 5 years;

3. Known history of previous anti-tumor treatment, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T cell-related therapy, etc;

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

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

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

7. Uncontrolled infection which needs systemic therapy;

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

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

10. Allergic to any component of the therapy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhen Zhang

Study Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhen Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, , China

Countries

China

Central Contacts

Zhen Zhang, MD

Role: CONTACT

zhen_zhang@fudan.edu.cn

18801735029

Yaqi Wang, MD

Role: CONTACT

10301010093@fudan.edu.cn

18121299593

Other Identifiers

FDRT-2023-290-3409

Identifier Type: -

Identifier Source: org_study_id