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The study evaluates the combination of immunotherapy of PD-1 antibody and chemotherapy and neoadjuvant short-course radiotherapy in locally advanced colon cancer (LACC). Patients are randomly assigned into two prospective groups: treatment group and observerment group. In treatment group, a total of 60 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 surgery. In observerment group: a total of 60 patients will receive 4 cycles of CAPOX chemotherapy, then receive the surgery. The rate of pathologic complete response (pCR), long-term prognosis and adverse effects will be analyzed.
This study is a prospective, randomized controlled, multicenter phase II study, with a design of superior efficacy,to compare the efficacy of neoadjuvant short-course radiotherapy combined with CapOX chemotherapy and PD-1 immunotherapy in locally advanced colon cancer. We will consecutively enrolled patients who were diagnosed with locally advanced colon cancer with T4 stage or bulky nodes. A total of 120 patients will be Randomized 1:1 to the treatment group and observerment group. In observerment group, patients will receive 4 cycles of CAPOX (Capecitabine: 1000mg/m2 d1-14 q3w; Oxaliplatin: 130mg/m2 d1 q3w)chemotherapy, then receive the surgery, followed by 4 cycles of CAPOX. In treatment group, patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOXand PD-1 antibody(Serplulimab,300mg d1 q3w), then receive the surgery,followed by 4 cycles of CAPOX.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| short-course radiotherapy and immunotherapy | Experimental | A total of 60 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the surgery. |
|
| chemotherapy | Active Comparator | A total of 60 patients will receive 4 cycles of CAPOX chemotherapy ,then receive the surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serplulimab | Drug | Serplulimab 300mg, d1, q3w |
| |
| Measure | Description | Time Frame |
|---|---|---|
| pCR | pCR was defined as the absence, from surgical samples, of malignant cells in the primary site and regional lymph nodes | The pCR rate will be evaluated after surgery, an average of 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | R0 resection refers to the complete removal of the tumor in the operation with microscopically negative margins | The R0 resection rate will be evaluated after surgery, an average of 4 weeks |
| 3 year overall survival rate |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38309748 | Derived | Zhang H, Li Y, Xia F, Sun Y, Shen L, Wan J, Chen Y, Wang Y, Zhou M, Wu R, Zhou S, Wang Y, Liu F, Cai S, Zhang Z. Study protocol of short-course radiotherapy combined with CAPOX and PD-1 inhibitor for locally advanced colon cancer: a randomised, prospective, multicentre, phase II trial (TORCH-C). BMJ Open. 2024 Feb 2;14(2):e079442. doi: 10.1136/bmjopen-2023-079442. |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
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| short-term radiotherapy |
| Radiation |
radiation: 25Gy/5Fx |
|
|
| Oxaliplatin | Drug | 130mg/m2 d1 q3w |
|
| Capecitabine | Drug | 1000mg/m2 d1-14 q3w |
|
|
Rate of 3 years overall survival
| From date of randomization until the date of death from any cause, assessed up to 3 years |
| 3 year disease free survival rate | Rate of 3 years disease free survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years. |
| Grade 3-4 adverse effects rate | Rate of chemotherapy, radiotherapy and immunotherapy related severe adverse events | From date of randomization until the date of death from any cause, assessed up to 5 years |
| 3 year local recurrence free survival rate | Rate of 3 years local recurrence free survival | From date of randomization until the date of first documented local-regional failure, assessed up to 3 years |
| Surgical complications | Rate of surgical complications, such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc. | The surgery was scheduled 2-4 weeks after the end of neoadjuvant therapy. And the surgical complications were assessed up to 5 years from the surgery |
| 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 |