Study on the Applicability of CCR Criteria in Rectal Cancer

Peking University Cancer Hospital & Institute

Status: Completed

Conditions: Immunotherapy; Neoadjuvant Chemoradiotherapy; Complete Response; PMMR/MSS Adenocarcinoma of the Colon or Rectum

Study type: Observational

Funder types: Other

Identifiers

NCT06794099

RECTUMCCR

Details and patient eligibility

About

This study aims to explore how well the usual ways of checking if rectal cancer patients are free of disease signs after treatment work for a new treatment method. The new method combines chemotherapy, radiation, and immune-boosting drugs before surgery. We know these usual ways work for the standard treatment, but we're not sure if they're good enough for this new combo treatment. We'll look at patients with a specific type of rectal cancer that doesn't respond well to just immune-boosting drugs alone. By comparing how patients treated with the new method and the old method respond, we hope to find better ways to tell if the treatment is really working, which could help improve treatment plans for these patients.

Enrollment: 177 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. histopathologically confirmed adenocarcinoma;
2. pMMR/MSS tumors;
3. clinical staging of T3-T4 or any lymph node-positive T (N+);
4. no evidence of distant metastasis based on radiological examinations;
5. treatment with long-course chemoradiotherapy (LCRT) with or without immune checkpoint inhibitors (ICI);
6. post-neoadjuvant therapy evaluation with endoscopy and pelvic MRI.

Exclusion criteria

1. Presence of other active malignancies;
2. Having severe comorbidities, such as heart failure, severe hepatic or renal insufficiency, etc;
3. Lack of imaging and endoscopic examinations;
4. Treatment plan does not meet the study requirements.

Trial design

177 participants in 2 patient groups

NACRT Group

Description:

Participants in the neoadjuvant chemoradiotherapy (NACRT) group will receive standard neoadjuvant chemoradiotherapy. This typically involves a combination of chemotherapy drugs administered concurrently with radiation therapy targeted at the rectal tumor. The chemotherapy regimen may include drugs such as fluorouracil (5-FU) and leucovorin, or capecitabine, which are commonly used in the treatment of rectal cancer.

NAICRT Group

Description:

Participants in the neoadjuvant chemoradiotherapy combined with immunotherapy (nICRT) group will undergo neoadjuvant chemoradiotherapy combined with immunotherapy. In addition to the standard chemotherapy and radiation therapy as described for the nCRT group, patients in this group will also receive immune checkpoint inhibitors (ICIs).