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The purpose of this study is to assess the efficacy and safety of QL1706 in combination with bevacizumab and/or chemotherapy versus sintilimab in combination with bevacizumab as first-line treatment in patients with advanced hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | QL1706 in combination with bevacizumab and chemotherapy |
|
| Arm 2 | Experimental | QL1706 in combination with bevacizumab |
|
| Arm 3 | Experimental | QL1706 in combination with chemotherapy |
|
| Arm 4 | Active Comparator | Sintilimab in combination with bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1706 | Drug | 7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) (Phase II) | ORR 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 | |
|---|---|---|---|---|
| Jian Gao | Contact | +8613304321400 | jian7.gao@qilu-pharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Jia Fan | Fudan University | Principal Investigator |
| Shukui Qin | Nanjing Tianyinshan Hospital | Principal Investigator |
| 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 |
|
| Sintilimab | Drug | 200 mg administered as IV infusion on Day 1 of each 21-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 |
| Progression-free Survival (PFS) | PFS 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 |
| Objective Response Rate (ORR) | ORR was assessed by investigators per mRECIST | Up to approximately 4 years |
| Disease Control Rate (DCR) | DCR was assessed by investigators per mRECIST | Up to approximately 4 years |
| Duration of Response (DOR) | DOR was assessed by investigators per mRECIST | Up to approximately 4 years |
| Progression-free Survival (PFS) | PFS was assessed by investigators per mRECIST | Up to approximately 4 years |
| Time to progression (TTP) | TTP was assessed by investigators per mRECIST | 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 |
| C000632826 | sintilimab |
| 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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