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

ConditionsLocally Advanced Rectal CancerNeoadjuvant Therapy
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • PD-1 inhibitor

    Drug

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

  • Capecitabine

    Drug

    Capecitabine: 1000mg/m2 bid d1-14 q3w

  • Short-course radiotherapy

    Radiation

    Short-course radiotherapy: 25Gy/5Fx

  • Oxaliplatin

    Drug

    Oxaliplatin 130mg/m2 d1 q3w

Treatment groups

192 Participants
are divided into 2 treatment groups
Group A: Immunochemotherapy groupExperimental treatment 3 interventions
Group B: Radiation plus immunochemotherapy groupExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Complete response (CR) rate

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

Time frame
1 month after the surgery or the decision of W&W

Secondary outcomes

1

Grade 3-4 adverse effects rate

Rate of chemotherapy, radiotherapy and immunotherapy related adverse events

Time frame
From date of randomization until 3 months after the completion neoadjuvant therapy
2

3 year organ or anal preservation rate

3 year organ or anal preservation rate

Time frame
From date of randomization until the resection of rectum or anus, assessed up to 36 months.
3

3 year disease free survival rate

Rate of 3 year disease free survival

Time frame
From 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.
4

3 year local recurrence free survival rate

Rate of 3 year local recurrence free survival

Time frame
From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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