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

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

Treatments tested in this trial

  • node-sparing short-course radiotherapy
  • Sintilimab
  • Capecitabine
  • Oxaliplatin
  • TME surgery
  • watch and wait

Treatment groups

37 Participants
are divided into 1 treatment group

Sponsors and collaborators