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Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer

ConditionEarly Low Rectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

About this trial

TORCH-E2 is a prospective, multicentre, randomized phase II trial. 134 low-lying early (T1-3b/N0-1M0, distance from anal verge ≤5cm) patients will be recruited and assigned to Group 1 and Group 2 (1:1). Group 1 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. Group 2 receives LCRT (50Gy/25Fx) followed by 2 cycles of CAPOX. A WW option can be applied to patients achieving cCR while surgery will be recommended for those who fail to achieve 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age 18-75 years old, female and male

pathological confirmed adenocarcinoma

clinical stage T1-3bN0-1, tumor maximum diameter less than 4cm

the distance from anal verge less than 5 cm

Disqualifiers

pregnancy or breast-feeding women

pathological confirmed signet ring cell carcinoma

clinical stage T1N0 and can be resected locally

history of other malignancies within 5 years

Trial design

Design model

Parallel

Treatments tested in this trial

  • Short-course radiotherapy

    Radiation

    Short-course radiotherapy: 25Gy/5Fx

  • PD-1 antibody (Toripalimab)

    Drug

    Toripalimab 240mg d1 q3w

  • Long-course radiotherapy

    Radiation

    Long-course radiation: 50Gy/25Fx

  • Oxaliplatin

    Drug

    Oxaliplatin: 130mg/m2 d1 q3w

  • Capecitabine

    Drug

    Xeloda

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: Short-course Radiotherapy plus immunochemotherapy groupExperimental treatment 4 interventions
Group B: Long-course Radiotherapy plus chemotherapy groupExperimental treatment 3 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

Organ preservation rate

Organ preservation rate

Time frame
from date of receiving neoadjuvant therapy, assessed up to 3 years
3

3 year disease free survival rate

Rate of 3 year disease free survival

Time frame
From date of initiation of treatment 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 initiation of treatment 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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