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| Name | Class |
|---|---|
| Anyang Tumor Hospital | OTHER |
| Fujian Cancer Hospital | OTHER_GOV |
| Shandong First Medical University | OTHER |
| Yunnan Cancer Hospital |
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This randomized phase II trial evaluates the efficacy of long-course chemoradiotherapy (50Gy/25Fx + capecitabine) versus short-course radiotherapy (25Gy/5Fx) combined with CAPOX(Capecitabine and Oxaliplatin), PD-1 inhibitor (serplulimab), and COX-2 inhibitor (celecoxib) in MSS(MicroSatellite Stable) locally advanced rectal cancer, with primary endpoint of complete response rate (pCR+cCR)(Complete Remission) and secondary endpoints including anal preservation rate and 3-year survival outcomes, aiming to elucidate the immunomodulatory effects of triple therapy on tumor microenvironment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-course chemoradiotherapy group | Experimental | The long-course chemoradiotherapy (LC-CRT) arm refers to a preoperative treatment regimen combining normofractionated radiotherapy with concurrent chemotherapy. |
|
| Short-course chemoradiotherapy group | Experimental | The short-course chemoradiotherapy group refers to a preoperative regimen combining hypofractionated radiotherapy with concurrent or sequential chemotherapy . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCRT | Radiation | 50Gy/25Fx |
| |
| SCRT |
| Measure | Description | Time Frame |
|---|---|---|
| CR (Complete Response) | Complete response (CR) in malignant tumor patients is defined as the complete disappearance of all target lesions, normalization of tumor marker levels, and absence of new lesions for ≥4 weeks after treatment. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| sphincter preservation rate | 3 years | |
| Grade 3 or higher toxicity rate | 3 years | |
| 3yPFS (Progression-Free Survival) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dawei Li | Contact | +86-021-64175590 | li_dawei@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Provincial Cancer Hospital | Recruiting | Fuzhou | Fujian | 350000 | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| OTHER |
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| Radiation |
25Gy/5Fx |
|
| CAPOX | Drug | 1000mg/m2 bid d1-14 |
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| PD-1 | Drug | 300mg d1,q3w |
|
| Celecoxib | Drug | 200mg, bid |
|
PFS (Progression-Free Survival) in oncology is defined as the time from the initiation of treatment to the occurrence of disease progression or death from any cause , whichever occurs first. |
| 3 years |
| 3yLRFS (Local Recurrence-Free Survival) | LRFS (Local Recurrence-Free Survival) is a clinical endpoint in oncology that measures the time from treatment initiation to the occurrence of local recurrence or death from any cause , whichever occurs first, commonly used to assess tumor control efficacy after surgery or radiotherapy. | 3 years |
| 3yOS (Overall Survival) | Measures the time until death , regardless of cause, reflecting the ultimate therapeutic outcome . | 3 years |
| Surgical complications | 3 years |
| Anyang Tumor Hospital | Recruiting | Anyang | Henan | 455100 | China |
|
| The First Affiliated Hospital of Shandong First Medical University | Recruiting | Jinan | Shandong | 250014 | China |
|
| Yunnan Cancer Hospital | Recruiting | Kunming | 650118 | China |
|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |