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The question of how to administer adequate chemotherapy and immunotherapy to synchronise hypofraction radiotherapy (HFRT) treatment strategy to maximise the benefits of neoadjuvant therapy for the improved prognosis of patients with locally advanced rectal cancer (LARC).We aimed to study whether chemotherapy and tislelizumab plus split-course HFRT results in better outcomes in LARC patients.
Prior to analyzing continuous variables, the statistical normality of the data will be determined. The differences between the main variables will be compared by using the analysis of variance. A comparison of data on categorical variables will be carried out by χ2 tests or Fisher's exact tests. The OS and PFS was estimated using the Kaplan-Meier method. PFS and OS will be compared using the log-rank test. In cases where variables must be adjusted, we will use the proportional hazard Cox regression model. P values for all analyses will be based on using a significance level of 0.05.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFRT with concurrent chemotherapy and immunotherapy | CAPOX chemotherapy plus tislelizumab treatment plus split-course HFRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| split-course HFRT | Radiation | 7Gy/F, d7, q3w, 5 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response(pCR) | pCR is defined as no residual tumor in the surgical specimen. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease-free survival | the time from randomization to disease recurrence or patient death due to disease progression. | 2 years |
| local recurrence rate | It's defined as disease-free proximal, distal and circumferential margins.And its progression was defined as an increase in tumor size. |
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Inclusion Criteria:
Exclusion Criteria:
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Hosptal in-patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benhua Xu | Contact | 86+13696884375 | benhuaxu@163.com | |
| Mengxia Zhang | Contact | 86+18305932021 | 18898534045@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Benhua Xu | Fujian Medical University Union Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36927585 | Derived | Zheng R, Wang BS, Li Z, Chi P, Xu B. Combining chemotherapy and tislelizumab with preoperative split-course hypofraction radiotherapy for locally advanced rectal cancer: study protocol of a prospective, single-arm, phase II trial. BMJ Open. 2023 Mar 16;13(3):e066976. doi: 10.1136/bmjopen-2022-066976. |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| C000707970 | tislelizumab |
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
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whole blood, tumor tissue
| CAPOX chemotherapy | Drug | CAPOX chemotherapy will commence on day 1 for each of six cycles: oxaliplatin 130 mg/m^2 intravenous infusion on day 1,followed by capecitabine 1000 mg/m^2 administered orally twice daily on day 1 to 14 of a 21-day cycle. |
|
|
| Tislelizumab | Drug | Tislelizumab 200 mg intravenous infusion on day 1 of each 21-day cycle for each of six cycles. |
|
|
| 3 years |
| overall survival(OS) | It's defined as the time after the first dose of study therapy to death from any cause. | 5 years |
| Sphincter-sparing surgery rate | sphincter-sparing surgery rate | 1 year |
| R0 Resection Rate(R0-R) | It's defined as the percentage of patients undergoing resection, defined as a tumour-free resection margin. | 1 year |
| predictive biomarkers andquality of life(QoL) | Objective condition index include subjective perception index objective condition index and subjective perception index. | 3 years |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| 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 |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |