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Completed

NCT Number: NCT06794099

Study on the Applicability of CCR Criteria in Rectal Cancer

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.

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Key information

Conditions

pMMR/MSS Adenocarcinoma of the Colon or Rectum Complete Response Disease Attributes Disease Progression Immunotherapy Neoadjuvant Chemoradiotherapy Pathologic Complete Response Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. sensitivity, specificity, accuracy, and AUC

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Jan 27, 2025
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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