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To explore the safety and efficacy of cryoablation combined with PD-1 antibody and bevacizumab for patients with hepatocellular carcinoma resistance to PD-1/L1 antibody.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | Cryoablation combined with PD-1 antibody and bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoablation | Procedure | After the completion of screening, the subjects received cryoablation treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | mRECIST is used as the evaluation criterion for CT/MRI imaging at each follow-up visit. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progress | mRECIST is used as the evaluation criterion for CT/MRI imaging at each follow-up visit. | Up to 2 years |
| Objective Response Rate | mRECIST is used as the evaluation criterion for CT/MRI imaging at each follow-up visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lingxiao Liu | Contact | +86-18616881019 | liulingxiao2022@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Zhou | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
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Cryoablation combined with PD-1 antibody and bevacizumab
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| PD-1 antibody and bevacizumab | Drug | Three days after cryoablation, the patients receive intravenous infusion of Tislelizumab (200mg, with 100mL of normal saline) and Bevacizumab (dose 15mg/kg, with 100mL of normal saline) .The patients will receive Tislelizumab (200 mg, with 100 mL of normal saline) and Bevacizumab (15 mg/kg, with 100 mL of normal saline) once every 3 weeks until disease progression. |
|
| Up to 2 years |
| Overall survival | According to medical documents or descriptions of the patient's family | Up to 2 years |
| Adverse events | CTCAE v5.0 is used to assess adverse events. | Up to 2 years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |