Study on the Applicability of CCR Criteria in Rectal Cancer

NCT06794099 | Completed DMC

• 1 other identifier: RECTUMCCR
• Study Type: observational
• Target: 177
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• sensitivity, specificity, accuracy, and AUC

  To evaluate the performance of clinical complete response (cCR) assessment criteria in patients treated with neoadjuvant chemoradiotherapy (nCRT) and neoadjuvant immunochemoradiotherapy (nICRT), we will utilize the area under the curve (AUC), accuracy, sensitivity, and specificity as key performance indicators. These metrics will help us assess the effectiveness of the cCR assessment criteria in both treatment groups.

  January 2025

Study Arms (2)

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.

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).

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective study evaluated medical records, endoscopic findings, and MRI images of rectal cancer patients who underwent neoadjuvant chemoradiotherapy (with or without immunotherapy) followed by surgery at Peking University Cancer Hospital between January 2019 and October 2024.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

This retrospective study does not involve biological specimens from patients.

MeSH Terms

Conditions

Pathologic Complete Response

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 27, 2025
• Study Start: January 1, 2019
• Primary Completion: October 1, 2024
• Study Completion: January 1, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)