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The study evaluates the combination of immunotherapy of PD-1 antibody and neoadjuvant short-course radiotherapy in early low rectal cancer. A total of 34 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody, finally receive the local excision(TEM) or total mesorectal excision (TME). The rate of complete response (cCR+pCR), Organ retention rate, long-term prognosis, and adverse effects will be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | A total of 34 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the TEM or TME surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 antibody | Drug | PD-1 antibody (Toripalimab): 240mg d1 q3w |
|
| Measure | Description | Time Frame |
|---|---|---|
| complete response (CR) rate | Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W&W strategy. | The status of cCR will be evaluated after the completion of neoadjuvant therapy. The pCR rate will be evaluated after surgery. The cCR patients who adopted W&W strategy will be included into the CR rate caluculation. |
| Measure | Description | Time Frame |
|---|---|---|
| Organ preservation rate | Rate of patients who underwent organ preservation via WW or TEM after neoadjuvant therapy | from date of receiving neoadjuvant therapy, assessed up to 2 years |
| Grade 3-4 adverse effects rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen Zhang, M.D, PH.D | Contact | 18801735029 | 18801735029 | zhen_zhang@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37802608 | Derived | Chen Y, Wang Y, Zhang H, Wan J, Shen L, Wang Y, Zhou M, Wu R, Yang W, Zhou S, Cai S, Li X, Zhang Z, Xia F. Short-course radiotherapy combined with chemotherapy and PD-1 inhibitor in low-lying early rectal cancer: study protocol for a single-arm, multicentre, prospective, phase II trial (TORCH-E). BMJ Open. 2023 Oct 6;13(10):e076048. doi: 10.1136/bmjopen-2023-076048. |
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Individual participant data that underlie the results reported in the related article, after deidentification (text, tables, figures, and appendices).
Beginning 3 months and ending 5 years following related article publication.
Proposals should be directed to xxx@yyy. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link will to be included).
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| ID | Term |
|---|---|
| C000711728 | spartalizumab |
| C000656314 | toripalimab |
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| Capecitabine | Drug | Capecitabine: 1000mg/m2 d1-14 q3w |
|
|
| Oxaliplatin | Drug | Oxaliplatin: 130mg/m2 d1 q3w |
|
| Short-course radiotherapy | Radiation | Shor-course radiotherapy: 25Gy/5Fx |
|
Rate of chemotherapy, radiotherapy and immunotherapy related adverse events
| From date of initiation of treatment until the date of death from any cause, assessed up to 5 years |
| 3 year disease free survival rate | Rate of 3 year disease free survival | From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months. |
| 3 year local recurrence free survival rate | Rate of 3 year local recurrence free survival | From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months. |
| 3 year overall survival rate | Rate of 3 year overall survival | From date of initiation of treatment until the date of death from any cause, assessed up to 36 months. |
| 10 year Quality of Life | Quality of life will be evaluated using EORTC QLQ-C30, EORTC QLQ-CR29, LARS score and Wexner score. | From date of initiation of treatment until the date of death from any cause, assessed up to 10 years |
| 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 |