Study on the Applicability of CCR Criteria in Rectal Cancer

Peking University Cancer Hospital & Institute177 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

177

Conditions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: January 2025