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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00418 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30CA124435 | U.S. NIH Grant/Contract | View source | |
| HEP0052 | Other Identifier | OnCore ID |
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Business decision - funding
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized phase III trial studies how well transarterial chemoembolization (TACE) works compared to stereotactic body radiation therapy (SBRT) or stereotactic ablative radiation therapy (SABR) in patients with liver cancer that remain after attempts to remove the cancer have been made (residual) or has come back (recurrent). TACE is a minimally invasive, image-guided treatment procedure that uses a catheter to deliver both chemotherapy medication and embolization materials into the blood vessels that lead to the tumors. SBRT or SABR may be able to send radiation directly to the tumor and cause less damage to normal liver tissue. It is not yet known whether TACE is more effective than SBRT or SABR in treating patients with persistent or recurrent liver cancer who have undergone initial TACE.
PRIMARY OBJECTIVES:
I. To determine the freedom from local progression (FFLP) of TACE versus (vs) SABR in patients with persistent hepatocellular carcinoma (HCC) after TACE.
SECONDARY OBJECTIVES:
I. To determine the progression-free survival (PFS) of TACE vs SABR in patients with persistent HCC after initial TACE.
II. To determine the overall survival (OS) of TACE vs SABR for persistent HCC. III. To determine the toxicities associated with TACE or SABR for persistent HCC.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients undergo TACE.
ARM II: Beginning within 2 weeks of the radiation set-up scan and within 4 weeks of fiducial seed implantation (if applicable), patients undergo image guided SBRT 3 fractions within 1 week or 5 fractions within 2 weeks.
After completion of study treatment, patients are followed up for 1-2 weeks, 1, 3, 6, 12, and 18 months, and every 6 months up to 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (TACE) | Active Comparator | Patients undergo TACE. |
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| Arm II (SBRT) | Experimental | Beginning within 2 weeks of the radiation set-up scan and within 4 weeks of fiducial seed implantation (if applicable), patients undergo image guided SBRT 3 fractions within 1 week or 5 fractions within 2 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy | Radiation | Undergo SBRT |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Local Progression Event | Local progression event: occurring in the treated hepatic lesion. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Median Freedom From Extra Hepatic Progression | The time to freedom from extra hepatic progression will be estimated by competing risk models with death as a competing risk. Risk factors such as tumor size and institution will be tested in a multivariate Cox regression model adjusting for the competing risks. | Up to 16 weeks |
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Inclusion Criteria:
Confirmed hepatocellular carcinoma (HCC) by one of the following:
Radiographic evidence of persistent, progressive, or recurrent disease in an area previously treated with TACE and determined from 3 months after initial TACE; this evaluation should be within 6 weeks of date of study eligibility
Unifocal liver tumors not to exceed 7.5 cm in greatest axial dimension; multifocal lesions will be restricted to lesions that can be treated within a single target volume within the same liver segment and to an aggregate of 10 cm as long as the dose constraints to normal tissue can be met
Eastern Clinical Oncology Group (ECOG) performance status 0, 1 or 2
Patients with liver disease classified as Child Pugh class A or B, with score =< 9 ((within 4 weeks of treatment)
Life expectancy >= 6 months
Ability of the research subject or authorized legal representative to understand and have the willingness to sign a written informed consent document
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erqi Liu Pollom, MD | Stanford University | Principal Investigator |
| Daniel Chang, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Palo Alto | California | 94304 | United States | ||
| Hokkaido University Hospital |
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13 participants signed informed consent, 12 were randomized to a study arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Transarterial Chemoembolization (TACE) | Patients undergo TACE using an embolic agent (gelatin sponge [gelfoam], polyvinyl alcohol particles, or embolic beads). |
| FG001 | Stereotactic Body Radiation Therapy (SBRT) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2022 |
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| Transarterial Chemoembolization | Procedure | Undergo TACE |
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| embolic agent | Drug | . Acceptable embolic agents include:
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| lipiodol | Drug |
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| Median Extra Hepatic PFS for Patients With Tumors Smaller Than 3 cm and Greater Than 3 cm Per Treatment Group |
Extra hepatic PFS within each subgroup will be summarized by cumulative incidence function estimators adjusted for the competing risk of death or regional or distant progression. |
| At 18 months |
| Median FFLP for Patients With Tumors Smaller Than 3 cm and With Tumors Greater Than 3 cm Per Treatment Group | FFLP within each subgroup will be summarized by cumulative incidence function estimators adjusted for the competing risk of death or regional or distant progression. | At 18 months |
| Median OS | Overall survival will be summarized using Kaplan-Meier curves and medians with 95% confidence intervals calculated using Greenwood's formula. Log rank tests will be used to compare treatment groups. Cox proportional hazard models will be used to estimate hazard ratios between treatment groups and to assess other risk factors, in particular the effect of tumor size and the impact of the different institutions. | Time from randomization until death from any cause, assessed up to 3 years |
| Median OS for Patients With Tumors Smaller Than 3 cm and Greater Than 3 cm Per Treatment Group | Within each subgroup OS will be summarized using Kaplan-Meier curves and medians with 95% confidence intervals calculated using Greenwood's formula. | At 18 months |
| Number of Participants With Disease Progression or Death | Including local, regional, or distant progression events, or death. Local progression event: occurring in the treated tumor. Regional progression event: occurring in the same part of the body as the treated tumor. Distant progression event: occurring outside the region of the body where the treated tumor is located. | Randomization through 3 years |
| Number of Participants With Disease Progression or Death by Tumor Size (<= 3 cm and > 3 cm) Per Treatment Group | Including local, regional, or distant progression events, or death. Local progression event: occurring in the treated tumor. Regional progression event: occurring in the same part of the body as the treated tumor. Distant progression event: occurring outside the region of the body where the treated tumor is located. | Randomization through 18 months |
| The Impact of Elevated Serum Alpha-Fetoprotein Level (AFP) on Freedom From Local Progression (FFLP) | The impact of elevated AFP level on time to event endpoints will be evaluated both in terms of the initial AFP level and on-study levels in a Cox proportional hazards model. | Up to 18 months |
| The Impact of Elevated Serum Alpha-Fetoprotein Level (AFP) on Progression-free Survival (PFS) | The impact of elevated AFP level on time to event endpoints will be evaluated both in terms of the initial AFP level and on-study levels in a Cox proportional hazards model. | Up to 18 months |
| The Impact of Elevated Serum Alpha-Fetoprotein Level (AFP) on Extra Hepatic PFS | The impact of elevated AFP level on time to event endpoints: FFLP, PFS, extra hepatic PFS and OS will be evaluated both in terms of the initial AFP level and on-study levels in a Cox proportional hazards model. | Up to 18 months |
| The Impact of Elevated Serum Alpha-Fetoprotein Level (AFP) on Overall Survival (OS) | The impact of elevated AFP level on time to event endpoints will be evaluated both in terms of the initial AFP level and on-study levels in a Cox proportional hazards model. | Up to 18 months |
| Sapporo |
| Hokkaido |
| 060-8648 |
| Japan |
Patients undergo image-guided SBRT (3 fractions within 1 week or 5 fractions within 2 weeks).
| Received Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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Participants who received treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Transarterial Chemoembolization (TACE) | Patients undergo TACE using an embolic agent. |
| BG001 | Stereotactic Body Radiation Therapy (SBRT) | Patients undergo image-guided SBRT. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Elevated Serum Alpha-Fetoprotein (AFP) | Participants with AFP data | Count of Participants | Participants |
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| 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 | Number of Participants With a Local Progression Event | Local progression event: occurring in the treated hepatic lesion. | Participants who received treatment | Posted | Count of Participants | Participants | Up to 12 months |
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| |||||||||||||||||||||||||||||
| Secondary | Comparison of Median Freedom From Extra Hepatic Progression | The time to freedom from extra hepatic progression will be estimated by competing risk models with death as a competing risk. Risk factors such as tumor size and institution will be tested in a multivariate Cox regression model adjusting for the competing risks. | Participants who received treatment | Posted | Median | 95% Confidence Interval | months | Up to 16 weeks |
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| |||||||||||||||||||||||||||||
| Secondary | Median Extra Hepatic PFS for Patients With Tumors Smaller Than 3 cm and Greater Than 3 cm Per Treatment Group | Extra hepatic PFS within each subgroup will be summarized by cumulative incidence function estimators adjusted for the competing risk of death or regional or distant progression. | Participants who received treatment | Posted | Median | 95% Confidence Interval | months | At 18 months |
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| Secondary | Median FFLP for Patients With Tumors Smaller Than 3 cm and With Tumors Greater Than 3 cm Per Treatment Group | FFLP within each subgroup will be summarized by cumulative incidence function estimators adjusted for the competing risk of death or regional or distant progression. | Participants who received treatment | Posted | Median | 95% Confidence Interval | months | At 18 months |
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| Secondary | Median OS | Overall survival will be summarized using Kaplan-Meier curves and medians with 95% confidence intervals calculated using Greenwood's formula. Log rank tests will be used to compare treatment groups. Cox proportional hazard models will be used to estimate hazard ratios between treatment groups and to assess other risk factors, in particular the effect of tumor size and the impact of the different institutions. | Participants who received treatment | Posted | Median | 95% Confidence Interval | months | Time from randomization until death from any cause, assessed up to 3 years |
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| |||||||||||||||||||||||||||||
| Secondary | Median OS for Patients With Tumors Smaller Than 3 cm and Greater Than 3 cm Per Treatment Group | Within each subgroup OS will be summarized using Kaplan-Meier curves and medians with 95% confidence intervals calculated using Greenwood's formula. | Participants who received treatment | Posted | Median | 95% Confidence Interval | months | At 18 months |
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| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Disease Progression or Death | Including local, regional, or distant progression events, or death. Local progression event: occurring in the treated tumor. Regional progression event: occurring in the same part of the body as the treated tumor. Distant progression event: occurring outside the region of the body where the treated tumor is located. | Participants who received treatment | Posted | Count of Participants | Participants | Randomization through 3 years |
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| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Disease Progression or Death by Tumor Size (<= 3 cm and > 3 cm) Per Treatment Group | Including local, regional, or distant progression events, or death. Local progression event: occurring in the treated tumor. Regional progression event: occurring in the same part of the body as the treated tumor. Distant progression event: occurring outside the region of the body where the treated tumor is located. | Participants who receive treatment | Posted | Count of Participants | Participants | Randomization through 18 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | The Impact of Elevated Serum Alpha-Fetoprotein Level (AFP) on Freedom From Local Progression (FFLP) | The impact of elevated AFP level on time to event endpoints will be evaluated both in terms of the initial AFP level and on-study levels in a Cox proportional hazards model. | Participants who received treatment | Posted | Median | 95% Confidence Interval | months | Up to 18 months |
|
| |||||||||||||||||||||||||||||
| Secondary | The Impact of Elevated Serum Alpha-Fetoprotein Level (AFP) on Progression-free Survival (PFS) | The impact of elevated AFP level on time to event endpoints will be evaluated both in terms of the initial AFP level and on-study levels in a Cox proportional hazards model. | Participants who received treatment | Posted | Median | 95% Confidence Interval | months | Up to 18 months |
|
| |||||||||||||||||||||||||||||
| Secondary | The Impact of Elevated Serum Alpha-Fetoprotein Level (AFP) on Extra Hepatic PFS | The impact of elevated AFP level on time to event endpoints: FFLP, PFS, extra hepatic PFS and OS will be evaluated both in terms of the initial AFP level and on-study levels in a Cox proportional hazards model. | Participants who received treatment | Posted | Median | 95% Confidence Interval | months | Up to 18 months |
|
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| Secondary | The Impact of Elevated Serum Alpha-Fetoprotein Level (AFP) on Overall Survival (OS) | The impact of elevated AFP level on time to event endpoints will be evaluated both in terms of the initial AFP level and on-study levels in a Cox proportional hazards model. | Participants who received treatment | Posted | Median | 95% Confidence Interval | months | Up to 18 months |
|
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Up to 3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transarterial Chemoembolization (TACE) | Patients undergo TACE using an embolic agent. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG001 | Stereotactic Body Radiation Therapy (SBRT) | Patients undergo image-guided SBRT. | 3 | 6 | 1 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| GI disorder other | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Bile duct stenosis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
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| Hepatic Pain | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
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| Portal Hypertension | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
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| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Alkaline Phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| ALT | Investigations | CTCAE (4.0) | Systematic Assessment |
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| AST increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Blood Bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| INR increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| WBC decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Investigations | CTCAE (4.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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This study did not enroll the planned number of participants and did not meet the protocol-prespecified threshold for statistical significance.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erqi Pollom, MD | Stanford University | (650) 498-0484 | erqiliu@stanford.edu |
| Dec 5, 2023 |
| Prot_SAP_000.pdf |
| 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 |
|---|---|
| D016634 | Radiosurgery |
| C020320 | ethylene-vinyl alcohol copolymer |
| D004998 | Ethiodized Oil |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D007459 | Iodized Oil |
| D010938 | Plant Oils |
| D009821 | Oils |
| D008055 | Lipids |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Japan |
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