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The aim of this study is to evaluate the safety and efficacy of neoadjuvant immunotherapy combined with chemotherapy before colonic resection in patients with locally advanced colon cancers
The trial is designed as an investigator-initiated, single center, prospective, single arm phase II study in patients with locally advanced colon cancers scheduled for intended curative surgery to determine the efficacy of immunotherapy using tislelizumab in the neoadjuvant setting. Patients will receive CapeOX + Terelizumab therapy(Day 1 through Day 21) following diagnosis. After 3 weeks a re-evaluation (to assess tumor response) will be performed, followed by standard surgery for resection of the tumor. Surgery will therefore be performed within 3 to 5 weeks after 2 cycle of neoadjuvant combined immunotherapy.. The patients will be followed as per the standard Danish guidelines with CT scans at 1 and 3 years after surgery. The specimen collected by surgery and clinical data will be collected . We use Integrative omics analysis to establish a clinical efficacy prediction model by means of bioinformatics to prospectively judge the efficacy and guide the follow-up individualized and accurate treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Locally Advanced Colon Cancers | Experimental | Cycle 1 to Cycle 2 CapeOX + Terelizumab therapy(Day 1 through Day 21) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terelizumab | Drug | q3w Terelizumab 200mg on day 1 of each cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response | Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging | 6 months |
| ORR (objective response rate) | Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathologic response (MPR) | It is defined as residual tumors less than 10% after neoadjuvant immunotherapy and(or) chemotherapy | 6 months |
| Overall survival (OS) | Time from study entry to death from any cause. |
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Inclusion Criteria:
2)The patient has adequate renal function as defined by a serum creatinine ≤1.5 times the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥50 mL/minute (that is, if serum creatinine is >1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed).
3)The patient has adequate hepatic function as defined by a total bilirubin ≤1.5 mg/dL (25.65 μmol/L), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases).
4)The patient must have adequate coagulation function as defined by international normalized ratio (INR) ≤1.5 8.Within 7 days before the first administration, women of childbearing age must confirm that the serum pregnancy test is negative and agree to use effective contraceptives during the study period and within 180 days after the last administration. In this program, women of childbearing age are defined as sexually mature women:
9.For male patients whose sexual partners are women of childbearing age, they must agree to use effective contraception during the study drug use and within 180 days after the last administration.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| fan L [fli] | Contact | 86 023 68757958 | levinecq@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daping hospital | Chongqing | 400042 | China |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| CapeOx |
| Drug |
Oxaliplatin(130mg/m2) on day 1 of each cycle and Capecitabine:Dose of 1000mg/m2,14days |
|
| 2 years |
| Disease-free survival (DFS) | Time from study entry to disease recurrence or patient death due to disease progression | 2 years |
| R0 resection rate | Rate of microscopically margin-negative resection | 6 months |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |