Study on the Applicability of CCR Criteria in Rectal Cancer

Applicability of CCR Assessment Criteria in PMMR Rectal Cancer Patients Treated with Neoadjuvant Chemoradiotherapy Combined with Immunotherapy

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 177

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Peking University Cancer Hospital & Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Neoplasms, Glandular and Epithelial; Carcinoma; Rectal Neoplasms; Adenocarcinoma
• Other Study ID Numbers: RECTUMCCR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No