Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This single-arm, open-label study assessed the efficacy and safety of Avastin (bevacizumab) treatment combined with transarterial chemoembolisation (TACE) in patients with localized unresectable liver cancer. Patients were treated with TACE at 8 or 10 week intervals for 4 sessions (continuation depended on investigator's discretion). Avastin 5 mg/kg intravenously was administered 24-48 hours prior to each TACE session and every 2 weeks between the TACE sessions until disease progression.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab 5 mg/kg | Experimental | Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab was supplied as a sterile liquid in single-use vials. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. | Baseline to the end of the study (up to 3 years, 3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Objective Response | An objective response was defined as a complete response or a partial response. A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong | 0 | Hong Kong | ||||
The Participant Flow data are discontinuations from bevacizumab treatment. Data for discontinuations from the study are not available.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab 5 mg/kg | Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat population: All participants who received study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab 5 mg/kg | Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival | Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. | Intent-to-treat population: All participants who received study medication. | Posted | Median | 95% Confidence Interval | Months | Baseline to the end of the study (up to 3 years, 3 months) |
|
Adverse events were reported from enrollment in the study up to 28 days after treatment completion.
Safety population: All participants who received at least 1 dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bevacizumab 5 mg/kg | Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (6.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (6.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 |
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Transarterial chemoembolisation (TACE) | Procedure | TACE was conducted by the transfemoral artery approach with selective cannulation of the artery supplying the tumor. Cisplatin mixed with Lipiodol in a 1 mg:1 mL ratio was infused intra-arterially up to a maximum dose of 30 mg, depending on tumor size, followed by embolization of the artery using Gelfoam particle until the blood flow slowed. Bilobar lesions were treated by separate catheterization of right and left hepatic arteries followed by injection of the cisplatin-Lipiodol mixture and embolization. Patients with stable disease or a partial response after 4 TACE sessions could be given further TACEs upon the investigator's discretion until there was evidence of progressive disease or contraindication due to severe complication or technical failure to perform the TACE. |
|
| Baseline to the end of the study (up to 3 years, 3 months) |
| Time to Progression | Time to progression was defined as the time from the first administration of study drug to the first documented disease progression. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. | Baseline to the end of the study (up to 3 years, 3 months) |
| Overall Survival | Overall survival was defined as the time from the first administration of study drug to death. | Baseline to the end of the study (up to 3 years, 3 months) |
| Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, or Stable Disease | A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the Baseline sum LD. Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the LD) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the LD for all target lesions will be calculated and reported as the Baseline sum LD. | Baseline to the end of the study (up to 3 years, 3 months) |
| Tumor Necrosis | Tumor necrosis was quantified in liver lesions greater than 2 cm at Baseline. When MRI showed many cut surfaces for a single tumor, tumor size and the size of necrotic area was measured by accumulation of the serial sections containing the tumor. Lipiodol accumulation in tumor after TACE was regarded as an indication of necrosis. Tumor necrosis was assessed at Baseline and 1 week prior to the next scheduled transarterial chemoembolisation (TACE) for the first 4 TACEs, then 1 week prior to every second TACE till disease progression. The extent of tumor necrosis is presented as the percentage of the tumor volume at Baseline. | Baseline to the end of the study (up to 3 years, 3 months) |
| Hong Kong |
| 852 |
| Hong Kong |
| Hong Kong | Hong Kong |
| Reason Unspecified |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Bevacizumab 5 mg/kg | Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals. |
|
|
| Secondary | Percentage of Participants With an Objective Response | An objective response was defined as a complete response or a partial response. A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. | Intent-to-treat population: All participants who received study medication. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to the end of the study (up to 3 years, 3 months) |
|
|
|
| Secondary | Time to Progression | Time to progression was defined as the time from the first administration of study drug to the first documented disease progression. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. | Intent-to-treat population: All participants who received study medication. | Posted | Median | 95% Confidence Interval | Months | Baseline to the end of the study (up to 3 years, 3 months) |
|
|
|
| Secondary | Overall Survival | Overall survival was defined as the time from the first administration of study drug to death. | Intent-to-treat population: All participants who received study medication. | Posted | Median | 95% Confidence Interval | Months | Baseline to the end of the study (up to 3 years, 3 months) |
|
|
|
| Secondary | Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, or Stable Disease | A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the Baseline sum LD. Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the LD) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the LD for all target lesions will be calculated and reported as the Baseline sum LD. | Intent-to-treat population: All participants who received study medication. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to the end of the study (up to 3 years, 3 months) |
|
|
|
| Secondary | Tumor Necrosis | Tumor necrosis was quantified in liver lesions greater than 2 cm at Baseline. When MRI showed many cut surfaces for a single tumor, tumor size and the size of necrotic area was measured by accumulation of the serial sections containing the tumor. Lipiodol accumulation in tumor after TACE was regarded as an indication of necrosis. Tumor necrosis was assessed at Baseline and 1 week prior to the next scheduled transarterial chemoembolisation (TACE) for the first 4 TACEs, then 1 week prior to every second TACE till disease progression. The extent of tumor necrosis is presented as the percentage of the tumor volume at Baseline. | Intent-to-treat population: All participants who received study medication. | Posted | Mean | Standard Deviation | Percentage of tumor volume at Baseline | Baseline to the end of the study (up to 3 years, 3 months) |
|
|
|
| 17 |
| 30 |
| 17 |
| 30 |
| Abdominal pain | Gastrointestinal disorders | MedDRA (6.0) | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (6.0) | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (6.0) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (6.0) | Systematic Assessment |
|
| Oesophageal perforation | Gastrointestinal disorders | MedDRA (6.0) | Systematic Assessment |
|
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA (6.0) | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (6.0) | Systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA (6.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (6.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (6.0) | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA (6.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (6.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (6.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (6.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (6.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (6.0) | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (6.0) | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (6.0) | Systematic Assessment |
|
| Liver carcinoma ruptured | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (6.0) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (6.0) | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (6.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (6.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (6.0) | Systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (6.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (6.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (6.0) | Systematic Assessment |
|
| Epistaxis | Vascular disorders | MedDRA (6.0) | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA (6.0) | Systematic Assessment |
|
| Injection site haematoma | Injury, poisoning and procedural complications | MedDRA (6.0) | Systematic Assessment |
|
| Puncture site haemorrhage | Injury, poisoning and procedural complications | MedDRA (6.0) | Systematic Assessment |
|
| Haemoptysis | Vascular disorders | MedDRA (6.0) | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Vascular disorders | MedDRA (6.0) | Systematic Assessment |
|
| Oesophageal varices | Gastrointestinal disorders | MedDRA (6.0) | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA (6.0) | Systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.0) | Systematic Assessment |
|
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA (6.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (6.0) | Systematic Assessment |
|
| Liver abscess | Hepatobiliary disorders | MedDRA (6.0) | Systematic Assessment |
|
| Hyperbilirubinaemia | Blood and lymphatic system disorders | MedDRA (6.0) | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA (6.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (6.0) | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (6.0) | Systematic Assessment |
|
| Oesophageal perforation | Gastrointestinal disorders | MedDRA (6.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (6.0) | Systematic Assessment |
|
| Portal vein thrombosis | Vascular disorders | MedDRA (6.0) | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D008107 |
| Liver Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Lesion 4 (N= 5) |
|
| Lesion 5 (N= 4) |
|