Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma With Localized Portal Vein Tumor Thrombosis

NCT ID: NCT06166576

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-20
• Study Completion Date: 2027-11-30

Brief Summary

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.

Detailed Description

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radioembolization

Hepatocellular carcinoma with localized portal vein tumor thrombosis (Vp1-Vp3) will be treated by ablative radioembolization using TheraSphere (Boston Scientific) glass microspheres

Group Type: EXPERIMENTAL

Ablative radioembolization

Intervention Type: 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.

Interventions

Ablative radioembolization

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Adults aged 18 and over

2. Patients diagnosed with unilobar hepatocellular carcinoma, either histologically and/or radiologically (LI-RADS 4 or 5)

3. Patients with at least one measurable lesion greater than 10 mm on dynamic contrast-enhanced CT or MRI

4. Patients with localized portal vein invasion limited in one lobe (Vp1-3) on dynamic contrast-enhanced CT or MRI

5. Patients with no extrahepatic metastasis on lung CT and contrast-enhanced abdominal CT or MRI

6. Patients with no prior treatment for liver cancer

7. Child-Pugh class A

8. Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less

9. Patients without serious dysfunction of major organs, as indicated by blood tests conducted within one month of study enrollment

1. Leukocytes ≥ 2,500/µL and ≤ 12,000/µL

2. Absolute neutrophil count ≥ 1,500/mm^3

3. Hemoglobin ≥ 8.0 g/dL (transfusions allowed to meet this criterion)

4. Total bilirubin ≤ 3.0 mg/dL

5. Platelets ≥ 50,000/µL

6. For patients not on anticoagulants, INR ≤ 2.0

7. AST ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)

8. ALT ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)

9. ALP ≤ 575 IU/L (i.e., ≤ 5X upper normal limit)

10. Creatinine ≤ 2.0 mg/dL

10. Patients with a life expectancy of more than 3 months

11. Patients who have fully understood the clinical trial and given written consent

12. Female patients of childbearing age confirmed not to be pregnant

Exclusion Criteria

1. Patients unsuitable for ablative radioembolization as per the pre-test with macro-aggregated albumin labeled with technetium-99 (99mTc-MAA) for radioembolization.

1. Cases where, according to multi-compartment Medical Internal Radiation Dose method, delivering 205 Gy of radiation to the tumor exceeds an estimated lung dose of 25 Gy.

2. Cases with severe hepatic artery-portal vein shunting leading to expected irradiation of the non-tumorous opposite lobe.

2. Patients whose volume of non-tumorous liver not included in the treatment area is less than 30% of the total non-tumorous liver volume.

3. Patients with hepatic vein or bile duct invasion as seen on dynamic contrast-enhanced CT or MRI.

4. Patients scheduled to use immunotherapy regardless of the response to radioembolization.

5. Patients who had active cancer within two years prior to joining the clinical trial.

6. Patients who have undergone surgery or procedures related to the bile duct.

7. Pregnant or breastfeeding women.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin Woo Choi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin Woo Choi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

National Cancer Center

Ilsan, Gyeonggi-do, South Korea

Site Status: RECRUITING

Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status: RECRUITING

Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jin Woo Choi, MD, PhD

Role: CONTACT

jwchoi.med@snu.ac.kr

+82-220722584

Facility Contacts

In Joon Lee, MD, PhD

Role: primary

2injoon@hanmail.net

+82 319200114

Jin Woo Choi, MD, PhD

Role: primary

jwchoi.med@snu.ac.kr

+82-220722584

Gyoung Min Kim

Role: primary

kimgm@yonsei.ac.kr

Dong-Ho Hyun, MD, PhD

Role: primary

mesentery@naver.com

References

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.

Reference Type: DERIVED

PMID: 39948248 (View on PubMed)

Other Identifiers

D-2306-207-1446

Identifier Type: -

Identifier Source: org_study_id