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According to the cancer statistics in 2020, colorectal cancer (CRC) remains a major public health issue worldwide, representing the third common cancer (10%) and second leading cause of death (9.4%) with 5-year survival rate approaching 65%. Meanwhile, 28.8% of the newly diagnosed cases and 30.3% of the CRC-related death occurs in China. Among all the CRC, stage I-III account for 75%. For the standard management for non-late stage(stage I-III) CRC patients, surgery including the primary site and local lymph nodes dissection has been the most important one. But for the high-risk stage II and locally-advanced stage III CRC, neoadjuvant or adjuvant therapy such as chemotherapy and radiotherapy plays a vital role in preventing the residual cancer cells to relapse and spread to distant sites after surgery. For the past decades, immunotherapy like anti-PD-1 and anti-CTLA4 checkpoint inhibitor achieves great process in solid tumor treatment especially for late-stage CRC. And Pembrolizumab and Nivolumab has been proved for dMMR/MSI-H late-stage-CRC by FDA. Combination of Ipilimumab and Nivolumab has achieved great success among the early-stage-CRC in NICHE study. The investigators here to carry out a phase II clinical trial to explore the safety and effect of single anti-PD-1 (Tisleizumab-BGB-A317 ) neoadjuvant treatment for non-late stage CRC patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dMMR/MSI-H stage I-III CRC patients | Experimental | Patients will accept 4 dose of Tisleizumab(BGB-A317) treatment after enrollment and the assessment of the therapeutic effect by clinicians would be finished after that. Once the patients has been qualified as cCR , they could be exempted for surgery and continued the watch and wait management. If the patient has been assessed as able to R0 surgery , then they would received surgery. Otherwise ,they would be excluded from the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tisleizumab(BGB-A317) | Drug | 200mg i.v. q3w |
|
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete regression rate | Patients without noninvasive or focal-invasive residues or involved lymph nodes should be considered as having achieved pCR. The rate is these patients over the whole group. | From enrollment to 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| CR rate | Patients with non-invasive or focal-invasive or involved lymph nodes which persists for 4 weeks after neoadjuvant immunotherapy. The rate of these patients over the whole group. | From enrollment to 1 year after surgery |
| Major Pathological Response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gong Chen, Prof | Contact | +86 020 87343584 | chengong@sysucc.org.cn | |
| Rong-xin Zhang, Prof | Contact | +86 020 87343584 | zhangrx@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Gong Chen, Prof | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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Rate of the patients who had focal invasive and residue tumor site which less than 10% both in primary tumors and all lymph nodes. |
| From enrollment to 1 year after surgery |
| Disease free survival | The time interval between the enrollment to the events such as relapse, distant metastasis and progressed occured. | From enrollment to 1 year after surgery |