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To evaluate the efficacy and safety of the combination therapy of SH006 injection in the treatment of advanced hepatocellular carcinoma
This is an open, randomized, multicenter study aimed at evaluating the safety and efficacy of SH006 injection (15 mg/kg) in combination with bevacizumab and/or oxaliplatin/capecitabine versus regorafenib in the treatment of patients with advanced hepatocellular carcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 SH006 in combination with bevacizumab and chemotherapy | Experimental |
| |
| Arm 2 SH006 in combination with bevacizumab | Experimental |
| |
| Arm 3 SH006 in combination with chemotherapy | Experimental |
| |
| Arm 4 Regorafenib | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SH006 | Drug | 15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) (Phase II) | PFS was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). | Up to approximately 4 years |
| Incidence of Adverse Events (AEs) (Phase II) | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. | Up to approximately 4 years |
| Overall Survival (OS) (Phase III) | OS was defined as the time from randomization to death due to any cause. | Up to approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR was assessed by investigators per RECIST 1.1 | Up to approximately 4 years |
| Disease Control Rate (DCR) | DCR was assessed by investigators per RECIST 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Min | Contact | 86-15121121360 | minjie@sanhome.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Tianyinshan Hospital | Nanjing | Jiangsu | 211199 | China |
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| Bevacizumab | Drug | 15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle |
|
| Oxaliplatin injection | Drug | 85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle |
|
| Capecitabine | Drug | 1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle |
|
| Regorafenib | Drug | 160 mg orally once daily for 21 days continuous dosing followed by a 7-day break of each 28-day cycle |
|
| Up to approximately 4 years |
| Duration of Response (DOR) | DOR was assessed by investigators per RECIST 1.1 | Up to approximately 4 years |
| Time to progression (TTP) | TTP was assessed by investigators per RECIST 1.1 | Up to approximately 4 years |
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
|
| 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 |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| C559147 | regorafenib |
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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