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Due to dMMR colon cancer patients respond poorly to conventional chemotherapy, but immunotherapy can significantly improve the pCR in this group of patients, this study intends to explore whether neoadjuvant immunotherapy can improve the R0 resection rate with preservation of adjacent organs in T4 colon cancer patients with dMMR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant immunotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab 200mg for 3 cycles. Patients will undergo surgery 2-3 weeks after the last cycle of immunotherapy, type and extent of the surgery will be selected by the surgeon. |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of R0 resection | No tumor infiltration within 1 mm of the surgical margins | Tumour specimen evaluated within 2 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response (pCR) | Number of patients with pCR evaluated according to the Mandard tumour regression grading system | Tumour specimen evaluated within 2 weeks after surgery. |
| diesease-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen Sun, M.D. | Contact | +86-18910598831 | sunzhen0906@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| C536928 | Turcot syndrome |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
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No tumor regrowth or recurrence or metastasis found
| 3 years |
| overall survival | Refers to the proportion of patients still alive at 5 years after surgery | 5 years |
| Safety and tolerability of Camrelizumab administered | Determined by the incidence and severity of treatment related adverse events according to CTCAE version 5.0 | Up to approximately 9 weeks |
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |