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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
| Shanghai Changzheng Hospital | OTHER |
| Huadong Hospital | OTHER |
| RenJi Hospital |
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This is an open-label, multi-center, single-arm clinical study. All patients received concurrent chemoradiation therapy (CRT) followed by 4 cycles of tislelizumab combined with CAPOX, then underwent clinical response assessment. Patients who achieved CR (cCR+ pCR confirmed by local resection of ncCR) continue tislelizumab combined with CAPOX for another 4 cycles and tislelizumab for 9 cycles, then Watch and Wait. Patients who did not achieved CR underwent total mesorectal excision (TME).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tislelizumab | Experimental | CRT followed by 4 cycles of tislelizumab plus CAPOX and clinical response assessment: participants with CR (cCR+ pCR confirmed by local resection of ncCR): another 4 cycles of tislelizumab plus CAPOX and 9 cycles of tislelizumab, then watch and wait. participants with non-CR: underwent TME |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | 45-50.4Gy in 25-28 fractions to the pelvis on Days 1-5 every week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response rate (CR rate) | defined as the proportion of participants with clinical complete response(cCR) or near clinical complete response (ncCR) who achieved local resection confirmed pCR determined by the investigators after CRT and 4 cycles of CAPOX plus tislelizumab. | From first dose up to 12 months, approximately |
| Measure | Description | Time Frame |
|---|---|---|
| 1/2/3 year organ-preservation rate | defined as the proportion of participants who survived and did not underwent TME in 1/2/3 year (in the CR set and full analysis set respectively) | From first dose of radiotherapy up to 36 months, approximately |
| 1/2/3 year EFS rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Jian Xu, MD | Contact | 86-21-64041990 | xujmin@aliyun.com | |
| Tao Wen Tang, MD | Contact | Tangwt1988@163.com |
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| OTHER |
| Hebei Medical University Fourth Hospital | OTHER |
| First Hospital of China Medical University | OTHER |
| Liaoning Cancer Hospital & Institute | OTHER |
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| Tislelizumab | Drug | 200 mg IV on Day 1 of each 21-day cycle. |
|
| Capecitabine | Drug | Capecitabine 1000 mg/m2 orally twice daily (bid) on Day 1 to 14 of each 21-day cycle in CAPOX regimen |
|
| Oxaliplatin | Drug | 130 mg/m2 IV on Day 1 of each 21-day cycle in CAPOX regimen |
|
| Capecitabine | Drug | 825 mg/m2 orally twice daily (bid) 5 days/week during radiotherapy. |
|
defined as the proportion of participants who did not develop local recurrence, distant metastasis, new invasive primary lesions of colorectal cancer, or death in 1/2/3 year (in the CR set, non-CR set and full analysis set respectively) |
| From first dose of radiotherapy up to 36 months, approximately |
| 1/2/3 year OS rate | defined as the proportion of participants who survived in 1/2/3 year (in the full analysis set) | From first dose of radiotherapy up to 36 months, approximately |
| Percentage of Participants With Adverse Events | Percentage of Participants With adverse events (AEs) , immune-related adverse events(irAE) and serious adverse events (SAEs) per the National Cancer Institute CommonTerminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 | From first dose of radiotherapy up to 36 months, approximately |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| C000707970 | tislelizumab |
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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