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The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer

ConditionEarly Low Rectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFudan University

About this trial

The study evaluates the combination of immunotherapy of PD-1 antibody and neoadjuvant short-course radiotherapy in early low rectal cancer. A total of 34 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody, finally receive the local excision(TEM) or total mesorectal excision (TME). The rate of complete response (cCR+pCR), Organ retention rate, long-term prognosis, and adverse effects will be analyzed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age 18-70 years old, female and male

pathological confirmed adenocarcinoma

clinical stage T1-3bN0, 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

Single group

Treatments tested in this trial

  • PD-1 antibody

    Drug

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

  • Capecitabine

    Drug

    Capecitabine: 1000mg/m2 d1-14 q3w

  • Oxaliplatin

    Drug

    Oxaliplatin: 130mg/m2 d1 q3w

  • Short-course radiotherapy

    Radiation

    Shor-course radiotherapy: 25Gy/5Fx

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: Treatment ArmExperimental 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
The status of cCR will be evaluated after the completion of neoadjuvant therapy. The pCR rate will be evaluated after surgery. The cCR patients who adopted W&W strategy will be included into the CR rate caluculation.

Secondary outcomes

1

Organ preservation rate

Rate of patients who underwent organ preservation via WW or TEM after neoadjuvant therapy

Time frame
from date of receiving neoadjuvant therapy, assessed up to 2 years
2

Grade 3-4 adverse effects rate

Rate of chemotherapy, radiotherapy and immunotherapy related adverse events

Time frame
From date of initiation of treatment until the date of death from any cause, assessed up to 5 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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