Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Complete Response | — | UNRESOLVED | — |
| Immunotherapy | — | UNRESOLVED | — |
| Neoadjuvant Chemoradiotherapy | — | UNRESOLVED | — |
| PMMR/MSS Adenocarcinoma of the Colon or Rectum | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- NACRT Group
- description
- 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.
- label
- NAICRT Group
- description
- 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).
Primary outcomes (1)
- measure
- sensitivity, specificity, accuracy, and AUC
- timeFrame
- January 2025
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available