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The RESOLVE trial, an open-label, single-arm, multi-center study, aims to assess the efficacy and safety of ablative radioembolization using TheraSphere Yttrium-90 microspheres. This trial specifically targets patients diagnosed with hepatocellular carcinoma accompanied by localized portal vein tumor thrombosis (Vp1-Vp3) and who maintain good liver function.
Patients diagnosed with unilobar hepatocellular carcinoma and localized portal vein tumor thrombosis (Vp1-Vp3), who also exhibit good liver function, will undergo ablative radioembolization with a dose exceeding 205 Gy to the tumor using TheraSphere glass microspheres. These patients will be monitored over a two-year period to evaluate their clinical course, treatment outcomes, and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radioembolization | Experimental | Hepatocellular carcinoma with localized portal vein tumor thrombosis (Vp1-Vp3) will be treated by ablative radioembolization using TheraSphere (Boston Scientific) glass microspheres |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablative radioembolization | Procedure | The interventional radiologist utilizes a pre-test with 99mTc-MAA SPECT-CT and cone-beam CT for procedural planning. For tumors confined to a single segment, the treatment area is planned to receive a radiation dose of over 400 Gy using the single-compartment MIRD technique. For tumors extending beyond a single segment, the multi-compartment MIRD technique is used to plan a radiation dose of 700 Gy (± 20%) to the tumor. The upper limit for the estimated lung dose is set at 25 Gy, and the upper limit for the perfused non-tumoral liver dose is 250 Gy. In cases where tumors extending beyond a single segment cannot receive the planned dose of 700 Gy (± 20%) due to limits on lung or normal liver dose, the plan is adjusted to deliver the maximum dose to the tumor within the permissible range for lung and normal liver doses. Radioembolization is typically performed in a single session, and any methods not mentioned here should follow the instructions for use of TheraSphere. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Time of treatment up to participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate according to mRECIST | Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled) | |
| Duration of response according to mRECIST |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-treatment dosimetry based on 99mTc-MAA SPECT-CT | Baseline | |
| Post-treatment dosimetry based on Y90 PET-CT | Within two days after the procedure |
Inclusion Criteria:
Adults aged 18 and over
Patients diagnosed with unilobar hepatocellular carcinoma, either histologically and/or radiologically (LI-RADS 4 or 5)
Patients with at least one measurable lesion greater than 10 mm on dynamic contrast-enhanced CT or MRI
Patients with localized portal vein invasion limited in one lobe (Vp1-3) on dynamic contrast-enhanced CT or MRI
Patients with no extrahepatic metastasis on lung CT and contrast-enhanced abdominal CT or MRI
Patients with no prior treatment for liver cancer
Child-Pugh class A
Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
Patients without serious dysfunction of major organs, as indicated by blood tests conducted within one month of study enrollment
Patients with a life expectancy of more than 3 months
Patients who have fully understood the clinical trial and given written consent
Female patients of childbearing age confirmed not to be pregnant
Exclusion Criteria:
Patients unsuitable for ablative radioembolization as per the pre-test with macro-aggregated albumin labeled with technetium-99 (99mTc-MAA) for radioembolization.
Patients whose volume of non-tumorous liver not included in the treatment area is less than 30% of the total non-tumorous liver volume.
Patients with hepatic vein or bile duct invasion as seen on dynamic contrast-enhanced CT or MRI.
Patients scheduled to use immunotherapy regardless of the response to radioembolization.
Patients who had active cancer within two years prior to joining the clinical trial.
Patients who have undergone surgery or procedures related to the bile duct.
Pregnant or breastfeeding women.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Woo Choi, MD, PhD | Contact | +82-220722584 | jwchoi.med@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Jin Woo Choi, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Recruiting | Ilsan | Gyeonggi-do | 10408 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39948248 | Derived | Choi JW, Kim GM, Hyun D, Jang MJ, Kim HC. Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma with Localized Portal Vein Tumor Thrombosis (RESOLVE): Protocol for an Open-label, Multi-center, Single-arm Trial. Cardiovasc Intervent Radiol. 2025 Mar;48(3):398-404. doi: 10.1007/s00270-024-03935-2. Epub 2025 Feb 13. |
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|
| Time of response up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled) |
| 2-year restricted mean duration of response according to localized mRECIST and mRECIST | Time of response up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or 24 months after the initial treatment |
| Complete response rate according to localized mRECIST and mRECIST | Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled) |
| Duration of complete response according to localized mRECIST and mRECIST | Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled) |
| 2-year restricted mean DoCR (RMDoCR) according to localized mRECIST and mRECIST | Time of complete response up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or 24 months after the initial treatment |
| Best response within 2-years according to localized mRECIST and mRECIST | Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled) |
| Time to best response according to localized mRECIST and mRECIST | Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled) |
| Time to progression according to localized mRECIST and mRECIST | Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled) |
| 2-year restricted mean survival time of overall survival | Time of treatment up to participant's death, opposition to data collection, lost to follow-up, or 24 months the initial treatment |
| Progression-free survival | Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled) |
| Hepatic progression-free survival | Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled) |
| Pathological necrosis rate (%) after curative resection or liver transplantation | Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled) |
| Time to subsequent HCC treatment | Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled) |
| Reason for subsequent HCC treatment | Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled) |
| Rate for conversion to curative resection and liver transplantation | Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled) |
| Adverse event and serious adverse event | Common Terminology Criteria for Adverse Events v5.0 | Time of treatment up to 90 days after the initial treatment or subsequent anticancer treatment, whichever comes first |
| Changes in Child-Pugh class | Baseline up to 90 days after the initial treatment or subsequent anticancer treatment, whichever comes first |
| Changes in ALBI (albumin-bilirubin) grade | Baseline up to 90 days after the initial treatment or subsequent anticancer treatment, whichever comes first |
| Changes in MELD (Model for end-stage liver disease) score | Baseline up to 90 days after the initial treatment or subsequent anticancer treatment, whichever comes first |
| Changes in ECOG (Eastern Cooperative Oncology Group) performance status scale | 0 (fully active) to 5 (dead) | Baseline up to 90 days after the initial treatment or subsequent anticancer treatment, whichever comes first |
| Objective response rate according to localized mRECIST | The number of patients with partial or complete response as the best local response divided by the total number of participants | Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled) |
| Duration of response according to localized mRECIST | The time from first documentation of partial or complete response to the first documentation of progressive disease, death due to any cause, or receipt of subsequent anticancer treatment, whichever comes first | Time of response up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled) |
| Seoul National University Hospital | Recruiting | Seoul | Seoul | 03080 | South Korea |
|
| Severance Hospital | Recruiting | Seoul | 03722 | South Korea |
|
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
|
| 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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