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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06794099

Enrollment

177

Registered

2025-01-27

Start date

2019-01-01

Completion date

2025-01-01

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
sensitivity, specificity, accuracy, and AUC	January 2025	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.

Countries

China

Outcome results