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| Name | Class |
|---|---|
| Jiangsu Hengrui Pharmaceutical Co., Ltd. | INDUSTRY |
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Hepatocellular carcinoma (HCC) is the most common primary liver cancer. Hepatectomy is a curable and effective method. However, the recurrence rate is as high as 50%~70% in 5 years after surgery. Perioperative treatment with immunotherapy combined with target therapy is expected to improve the patient's prognosis. This study aims to evaluate the efficacy, safety and tolerability of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The primary purpose of this study is to evaluate 2 year event-free survival(2y-EFS) of camrelizumab combined with apatinib mesylate in the perioperative period of hepatocellular carcinoma (CNLC Ib-IIIa). The secondary research purpose is to evaluate the R0 resection rate, the rate of subjects with major pathological response, the rate of subjects with pathological complete response, event-free survival (EFS) and overall survival of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The safety and tolerability is also evaluated.
Hepatocellular carcinoma (HCC) is the most common primary liver cancer. Hepatectomy is a curable and effective method. However, the recurrence rate is as high as 50%~70% in 5 years after surgery. Perioperative treatment with immunotherapy combined with target therapy is expected to improve the patient's prognosis. This study aims to evaluate the efficacy, safety and tolerability of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. This trial includes subjects with CNLC Ib/IIa/IIb/IIIa HCC. All eligible subjects will be randomized (1:1) to experimental group or control group. In the experimental group, patients will be treated with following: neoadjuvant therapy ( perioperative TACE treatment,camrelizumab and apatinib, 2 cycles), radical surgery, adjuvant therapy (camrelizumab and apatinib, 6 cycles); in the control group, patients will be treated with following: radical surgery,adjuvant therapy (camrelizumab and apatinib, 6 cycles). The primary purpose of this study is to evaluate 2 year event-free survival(2y-EFS) of camrelizumab combined with apatinib mesylate in the perioperative period of hepatocellular carcinoma (CNLC Ib-IIIa). The secondary research purpose is to evaluate the R0 resection rate, the rate of subjects with major pathological response, the rate of subjects with pathological complete response, event-free survival (EFS) and overall survival of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The safety and tolerability is also evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Preoperative TACE treatment → preoperative camrelizumab combined with apatinib mesylate (q2w, 2 cycles) → radical surgery → sequential camrelizumab and apatinib mesylate (q3w, at least 6 cycles) |
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| Control group | Active Comparator | Radical surgery → sequential camrelizumab and apatinib mesylate (q3w, at least 6 cycles) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab is administered at 200mg, q2w (2cycles) before radical surgery and 200mg, q3w (at least 6 cycles) after radical surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2 year event-free survival(2y-EFS) | 2y-EFS is defined as time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, or death due to any cause. | 2-year |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | R0 resection rate | 30-day |
| The rate of subjects of major pathological response (MPR) | MPR is defined as less than 10% residual tumor after neoadjuvant therapy of camrelizumab and apatinib therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuehao Wang, professor | Contact | 86-025-68303211 | Wangxh@njmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xuehao Wang, professor | The First Affiliated Hospital with Nanjing Medical University | Study Chair |
| Yongxiang Xia | The First Affiliated Hospital with Nanjing Medical Univer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Province Hospital | Recruiting | Nanjing | Jiangsu | 210029 | China |
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| Apatinib Mesylate | Drug | Apatinib Mesylate is administered at 250mg, qd (2 cycles) before radical surgery and 250mg, qd (at least 6 cycles) after radical surgery |
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| Radical surgery | Procedure | Radical surgery |
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| Preoperative TACE treatment | Procedure | TACE treatment before preoperative camrelizumab combined with apatinib mesylate |
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| Camrelizumab | Drug | Camrelizumab is administered at 200mg, q3w (at least 6 cycles) after radical surgery |
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| Apatinib Mesylate | Drug | Apatinib Mesylate is administered at 250mg, qd (at least 6 cycles) after radical surgery |
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| 30-day |
| the rate of subjects with pathological complete response (pCR) | pCR is defined as no histologic evidence of malignancy or only the ingredients of carcinoma in situ was found in primary tumors. | 30-day |
| Overall survival (OS) | OS is defined as the time from randomisation to death. | 3-year |
| Event-free survival (EFS) | EFS is defined as the time from randomisation to tumor progression, postoperative relaspse or metastasis, or death, which occur first. | 3-year |
| Disease-free survival (DFS) | DFS is defined as the time from randomization until disease recurrence or death from any cause. | 3-year |
| Adverse event (AE) | Adverse events (AEs) ; serious adverse events (SAEs); surgery related safety. | 3-year |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
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