Study on the Applicability of CCR Criteria in Rectal Cancer

NCT ID: NCT06794099

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 177 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2025-01-01

Brief Summary

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

NACRT Group

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.

No interventions assigned to this group

NAICRT Group

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).

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

RECTUMCCR

Identifier Type: -

Identifier Source: org_study_id