Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a prospective, single-arm, phase Ⅱtrial. The subjects are patients resectable centrally-located hepatocellular carcinoma in BCLC stage B who are admitted to the Hepatobiliary Surgery Department of Tongji Hospital , Tongji Medical College, Huazhong University of Science and Technology, are over 18 years old, and have signed the informed consent form to voluntarily participate in this study. Through the neoadjuvant treatment of Apatinib mesylate and Camrelizumab combined with TACE before liver resection, it is expected to reduce the tumor size, lower the tumor burden, increase the surgical margin, improve the R0 resection rate, decrease the postoperative recurrence risk, and prolong the overall survival.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TACE combined with Camrelizumab and Apatinib | Experimental | Patients in the neoadjuvant treatment group will receive TACE treatment within one week after enrollment. One week after the resolution of the TACE treatment syndrome, they will be given Camrelizumab (200 mg, once every two weeks, for a total of 4 cycles) and oral Apatinib mesylate tablets (250 mg, once a day, for a total of 2 months).To ensure surgical safety, Camrelizumab should be discontinued at least two weeks before surgery, while Apatinib should be discontinued at least one week before surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE (transarterial chemoembolization) combined with targeted/immunotherapy | Drug | Patients in the neoadjuvant treatment group will receive TACE treatment within one week after enrollment. One week after the resolution of the TACE treatment syndrome, they will be given Camrelizumab (200 mg, once every two weeks, for a total of 4 cycles) and oral Apatinib mesylate tablets (250 mg, once a day, for a total of 2 months).To ensure surgical safety, Camrelizumab should be discontinued at least two weeks before surgery, while Apatinib should be discontinued at least one week before surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Two-year disease-free survival rate | DFS is defined as the time from surgical resection to local recurrence. | From the time of undergoing the surgery to two years later |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | It refers to the proportion of patients whose tumors have shrunk to a certain extent and maintained that state for a certain period of time (mainly for solid tumors), including cases of complete response (CR, Complete Response) and partial response (PR, Partial Response). | The period from the onset of therapeutic effect until the confirmation of tumor progression,up to 24 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| WeiZhang, MD | Contact | 086-13986029425 | weizhangtjh@hust.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| MPR | The residual surviving tumor tissue is ≤ 30%. | max 24 months |
| TTR | TTR is defined as the time from the start of treatment until the first objectiveobservation of a response (either partia response, PR,or complete responseCR),provided that the response is subsequently confirmed | max 24 months |
| OS | OS is defined as the time from study treatment to the date of death of thesubject, regardless of the cause of death. | max 24 months |
| DCR | The proportion of patients who achieve complete response (CR) , partial response (PR) , or stable disease (SD) for a specified minimum duration according to standardized response criteria | max 24 months |
| R0 resection rate | The proportion of cases where the tumor is completely removed and the microscopic margins are negative, meaning there is no tumor residue remaining. | max 24 months |
| AE | Adverse events (AEs), Serious Adverse events (SAEs), surgery related safety. | max 24 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |