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•This is a randomized, open-label, multi-center, phases 2 and phase 3 trial to evaluate the efficacy and safety of SBRT combined with Camrelizumab and Apatinib as conversion therapy versus Camrelizumab combined with Apatinib as first-Line therapy for unresectable hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental |
| |
| control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation | Radiation | Subjects receive Stereotactic Body Radiotherapy combined with Camrelizumab and Apatinib as conversion therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The primary endpoint of phase 3 study is OS | Up to approximately 3 years |
| The R0 Resection rate of the experimental group | The primary endpoint of phase 2 study is the R0 Resection rate of the experimental group | Up to approximately 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The ORR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively. | Up to approximately 3 years |
| Disease control rate (DCR) | The DCR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Kuang | Contact | +86-020-87755766 | kuangm@mail.sysu.edu.cn | |
| Lixia Xu | Contact | +86-020-87755766 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
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| First line therapy | Drug | Subjects receive Camrelizumab intravenously. Subjects receive Apatinib orally. |
|
| First line therapy | Drug | Subjects receive Camrelizumab intravenously. Subjects receive Apatinib orally. |
|
| operation | Procedure | If subjects suitable for hepatic resection after conversion therapy, radical surgery and postoperative adjuvant therapy will be performed. |
|
| Up to approximately 3 years. |
| Time to Response (TTR) | The TTR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively. | Up to approximately 3 years. |
| Duration of response (DoR) | The DoR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively. | Up to approximately 3 years. |
| Time to progression (TTP) | The TTP is assessed by The investigators according to RECIST v1.1 and mRECIST, | Up to approximately 3 years. |
| Event free survival (EFS) | The EFS is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively. | Up to approximately 3 years. |
| Conversion rate | The conversion rate of the experimental group. | Up to approximately 30 days. |
| Resection rate | The resection rate of the experimental group. | Up to approximately 30 days. |
| R0 resection rate | The R0 resection rate of the experimental group. | Up to approximately 30 days. |
| Pathologic complete response (pCR) rate | The pCR rate of the experimental group. | Up to approximately 30 days. |
| Major pathological response (MPR) | The MPR rate of the experimental group. | Up to approximately 30 days. |
| Safety | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Up to approximately 90 days. |
| ID | Term |
|---|---|
| D011827 | Radiation |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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