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This is a multi-center,open-label study to evaluate the efficacy and safety of anti-PD-1 antibody HX008 plus bevacizumab or lenvatinib in the first-line treatment of patients with unresectable hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: HX008+Bevacizumab | Experimental | Participants receive HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus bevacizumab 15 mg/kg, IV, Q3W. |
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| Experimental: HX008+Lenvatinib | Experimental | Participants receive HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight <60 kg) orally once a day (QD). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HX008 | Drug | 200 mg administered as IV infusion on Day 1 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR was defined as the percentage of participants who have a complete response (CR) or a partial response (PR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators. | Up to approximately 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | DCR was defined as the percentage of participants who have a CR or a PR or a stable disease (SD), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators. | up to approximately 15 months |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianqiang Cai | Contact | 010-67781331 | caijianqiang188@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fist Affiliated Hospital of USTC(Anhui Provincial hospital) | Not yet recruiting | Hefei | Anhui | 230001 | China |
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| Bevacizumab | Drug | 15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle. |
|
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| Lenvatinib | Drug | Administered orally once a day during each 21-day cycle |
|
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DOR was defined as the time from the first documented evidence of a response of CR or PR, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators. |
| up to approximately 15 months |
| Progression-free Survival (PFS) | PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 assessed by investigators or death due to any cause, whichever occurs first. | up to approximately 15 months |
| Overall Survival (OS) | OS was defined as the time from the date of beginning of HX008 administration until date of death from any cause. | up to approximately 20 months |
| Time to Disease Progression (TTP) | TTP is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by investigators. | up to approximately 15 months |
| Number of participants with adverse events (AEs) | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment | up to approximately 20 months |
| Cancer Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| Beijing Yuhe Integrated Traditional Chinese and Western Medicine Rehabilitation Hospital | Recruiting | Beijing | Beijing Municipality | 100089 | China |
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| Cancer Hospital Chinese Academy of Medical Sciences, shenzhen center | Not yet recruiting | Shenzhen | Guangdong | 518116 | China |
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| Harbin Medical University Cancer Hospital | Recruiting | Harbin | Heilongjiang | 150081 | China |
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| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | 450004 | China |
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| Hunan Provincial People's Hospital | Recruiting | Changsha | Hunan | 410000 | China |
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| The First Affiliated University of Nanhua University | Recruiting | Hengyang | Hunan | 421000 | China |
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| The Sixth People's Hospital of Shenyang | Recruiting | Shenyang | Liaoning | 110000 | China |
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| The Affiliated Hospital of Qingdao University | Not yet recruiting | Qingdao | Shandong | 266000 | China |
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| West China Hospital, Sichuan University | Not yet recruiting | Chengdu | Sichuan | 610041 | China |
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| Tianjin Cancer Hospital | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
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| The Central Hospital of Lishui City | Recruiting | Lishui | Zhejiang | 323000 | 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 |
| 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 |
|---|---|
| D000068258 | Bevacizumab |
| C531958 | lenvatinib |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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