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Node-sparing Radiotherapy Combined With Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer

ConditionLocally Advanced Rectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJinhua Central Hospital

About this trial

phase II clinical trial to evaluate node-sparing short-course radiation combined with total neoadjuvant CAPOX and Sintilimab for MSS locally advanced rectal cancers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy.

Male or Female aged 18-75.

Patients diagnosed with low rectal cancer within 10 cm from the lower edge of the tumor to the anal verge by pelvic MRI and anorectoscopy, the clinical stage is cT2N+M0/cT3-4N0/+M0, the lymph nodes are limited to the mesorectum.

Histologically confirmed rectal adenocarcinoma; Genetic testing suggests MSI-L or MSS, or tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive.

Disqualifiers

Patients with a previous history of malignant tumors besides rectal cancer.

Patients with distant metastases before enrollment.

Patients with positive internal or external iliac lymph nodes are assessed by MRI or CT.

Patients with obstruction, perforation, or bleeding that require emergency surgery.

Trial design

Design model

Single group

Treatments tested in this trial

  • node-sparing short-course radiotherapy

    Radiation

    5Gy\*5d, radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes

  • Sintilimab

    Drug

    200mg intravenous infusion d1 of each cycle\*6cycles

  • Capecitabine

    Drug

    1000mg/m2, PO, BID, d1-14 of each cycle\*6cycles

  • Oxaliplatin

    Drug

    130mg/m2, intravenous infusion,d1 of each cycle\*6cycles

  • TME surgery

    Procedure/Surgery

    laparoscopic or robotic TME surgery for non-cCR patients

  • watch and wait

    Procedure/Surgery

    WW for cCR patients

Treatment groups

37 Participants
are divided into 1 treatment group
Group A: Treatment ArmExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Complete response

Pathological complete response (pCR) ：absence of residual tumour on resected specimen. Clinical complete response（cCR）: no residual tumour visible on imaging or colonoscopy and biopsy.

Time frame
within 10 days after TNT therapy or surgery

Secondary outcomes

1

Tumor regression grade

TRG is evaluated according to the AJCC system. TRG0-1 is defined as good response, TRG2 as moderate response, and TRG3 as poor response.

Time frame
within 10 days after surgery
2

Local recurrence rate(LRR)

Presence of adenocarcinoma within the rectal wall or within the mesorectum confirmed by pathology.

Time frame
3 years after sugery
3

Disease free survival(DFS)

the time from randomization to recurrence of tumor or death

Time frame
3 years after treatment
4

Overall survival(OS)

the time from randomization to death

Time frame
3 years after enrollment

Other outcomes

Sponsors and contacts

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

Jinhua Central Hospital

Lead sponsor

Source ClinicalTrials.gov
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