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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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 |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital & Institute | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D000095384 | Pathologic Complete Response |
| ID | Term |
|---|---|
| D018450 | Disease Progression |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This retrospective study does not involve biological specimens from patients.