Hepatocellular CarcinomaNCT05984511
TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT
A study testing I-125 Seeds Brachytherapy in PVTT, Transcatheter arterial chemoembolization and Atezolizumab plus Bevacizumab in people with Hepatocellular Carcinoma and Hepatic Portal Vein Tumor Invasion, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The present study aimed to assess the effectiveness of the combination treatment of Atezolizumab/Bevacizumab, transcatheter arterial chemoembolization (TACE) and I-125 Seeds Brachytherapy (TACE-AB-I) in patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatic Portal Vein Tumor Invasion, Tumor Thrombus
- What is being tested?
- I-125 Seeds Brachytherapy in PVTT, Transcatheter arterial chemoembolization and Atezolizumab plus Bevacizumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2023to 1 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between18 and 75 years;
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- Type I PVTT or type II PVTT;
- Child-Pugh class A;
- Eastern Cooperative Group performance status (ECOG) score of 0-1;
- No prior systemic therapy for HCC.
- Adequate hematologic and end-organ function;
- At least one measurable intrahepatic target lesion.
Who cannot join
- Diffuse HCC;
- Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes (confirmed by histology, or pathology) are not eligible;
- Evidence of extrahepatic spread (EHS);
- Any condition representing a contraindication to TACE or I-125 seeds brachytherapy as determined by the investigators;
- Evidence or history of bleeding diathesis or any hemorrhage or bleeding event >CTCAE grade 3 within 4 weeks prior to randomization;
- Active or history of autoimmune disease or immune deficiency;
Show all 15Show fewer
- Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk for bleeding;
- A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment;
- Evidence of bleeding diathesis or significant coagulopathy;
- Pregnant or breastfeeding females;
- Significant cardiovascular disease;
- Severe infection, such as active tuberculosis;
- Serious medical comorbidities;
- History of organ or cells transplantation;
- History of other uncurable malignancies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangzhou, 510630
Mingsheng Huang
About this study
Official title: TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT: A Phase III, Randomized Clinical Trial
The present study aimed to assess the effectiveness of the combination treatment of Atezolizumab/Bevacizumab, transcatheter arterial chemoembolization (TACE) and I-125 Seeds Brachytherapy (TACE-AB-I) in patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT). The investigators confirmed that the combination therapy yielded better survival data than the combined administration of Atezolizumab/Bevacizumab and TACE (TACE-AB) in patients with advanced HCC and Type I/II PVTT (Based on Cheng's PVTT classification).
Read the detailed description
This is a multicenter, open-label trial, randomized controlled to evaluate the efficacy and safety of TACE-AB-I compared with TACE-AB for the treatment of HCC with branch PVTT. 234 HCC patients with branch PVTT will be enrolled in this study. The Patients will be treated with TACE-AB-I or TACE-AB using a 1:1 randomization scheme. TACE will be performed for the patients after randomization. Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE and I-125 Seeds Brachytherapy and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the TACE-AB-I arm, iodion-125 seeds will be implanted into the PVTT (according to the pre-operative planning) under CT guidance within 3-7 days after the first TACE. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
- Being tested
- I-125 Seeds Brachytherapy in PVTT, Transcatheter arterial chemoembolization, Atezolizumab plus Bevacizumab
- Keywords
- Hepatocellular Carcinoma (HCC), Portal vein tumor thrombosis (PVTT), Transcatheter arterial chemoembolization (TACE), I-125 Seeds Brachytherapy, Atezolizumab plus Bevacizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-125 Seeds Brachytherapy in PVTTProcedure or surgery
Also called Iodine-125 Seeds Implantation
Iodine125 seed implantation into the PVTT was conducted 3-7 days after TACE when the results of the liver function tests were comparable to those obtained before TACE. Pre-procedural planning was conducted using a three-dimensional conformal radiation therapy treatment planning system (TPS) to determine the number of Iodine125 seeds required, the target location for implantation, the best percutaneous puncture site and the access route. The targeted zone for implantation was the tumour thrombosis in the segmental portal vein, left/right portal vein. Implantation was guided by CT, and the Iodine125 seeds were implanted into the PVTT using 18 G needles and the implantation gun that housed the Iodine125 seeds in the cartridge chamber.
Transcatheter arterial chemoembolizationProcedure or surgery
Also called TACE
TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE).
Atezolizumab plus BevacizumabDrug
Also called atezolizumab-bevacizumab; Atez/Bev treatment
Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) .
| Study group | Role | What they receive |
|---|---|---|
| TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I) | Experimental | TACE will be performed for the patients after randomization. Iodion-125 seeds will be implanted into the PVTT under CT guidance within 3-7 days after the first TACE.
Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE and I-125 Seeds Brachytherapy.
TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination. Receives: Procedure: I-125 Seeds Brachytherapy in PVTT; Procedure: Transcatheter arterial chemoembolization; Drug: Atezolizumab plus Bevacizumab |
| TACE and Atezolizumab/Bevacizumab (TACE-AB) | Active comparator | TACE will be performed for the patients after randomization. Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE.
TACE can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination. Receives: Procedure: Transcatheter arterial chemoembolization; Drug: Atezolizumab plus Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Time from randomization to death from any cause.
Measured: 2 years
Secondary outcomes (4)
Progression free survival (PFS)
Time from randomization to disease progression (mRECIST) or death from any cause, whichever occurred first.
Measured: 2 years
Objective response rate (ORR)
The percentage of patients who had a best overall tumor response rating of CR and PR (mRECIST).
Measured: 2 years
Duration of portal patency
The time from randomization until the date that complete portal vein occlusion was confirmed (if the portal vein is patent at diagnosis).
Measured: 2 years
Adverse events (AEs)
Number of patients with AE, treatment-related AE (TRAE), AE of special interest (AESI), serious adverse event (SAE), assessed by NCI CTCAE v5.0.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start30 Aug 2023
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter, open-label trial, randomized controlled trial to evaluate the efficacy and safety of TACE-AB-I compared with TACE-AB for the treatment of HCC with branch PVTT.
- Masking
- None (open label)
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen University Cancer Center, Fifth Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital of Guangzhou Medical University, Maoming People's Hospital, Shandong Province Third hospital
- Responsible party
- Principal investigator, Huang Mingsheng, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Mingsheng Huang, M.D. & Ph.D., Principal investigator, Department of Interventional Radiology, The Third Affiliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984511
- Sponsor's protocol ID
- II2023-162-02
- Status last verified
- Feb 2025
- First submitted
- 26 Jul 2023
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan to share IPD with collaborators.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT: A Phase III, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05984511
- Acronym / sponsor ID
- II2023-162-02
- Keywords
- Hepatocellular Carcinoma (HCC), Portal vein tumor thrombosis (PVTT), Transcatheter arterial chemoembolization (TACE), I-125 Seeds Brachytherapy, Atezolizumab plus Bevacizumab
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-Sen University Cancer Center, Fifth Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital of Guangzhou Medical University, Maoming People's Hospital, Shandong Province Third hospital
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aimed to assess the effectiveness of the combination treatment of Atezolizumab/Bevacizumab, transcatheter arterial chemoembolization (TACE) and I-125 Seeds Brachytherapy (TACE-AB-I) in patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT). The investigators confirmed that the combination therapy yielded better survival data than the combined administration of Atezolizumab/Bevacizumab and TACE (TACE-AB) in patients with advanced HCC and Type I/II PVTT (Based on Cheng's PVTT classification).
Detailed description
This is a multicenter, open-label trial, randomized controlled to evaluate the efficacy and safety of TACE-AB-I compared with TACE-AB for the treatment of HCC with branch PVTT. 234 HCC patients with branch PVTT will be enrolled in this study. The Patients will be treated with TACE-AB-I or TACE-AB using a 1:1 randomization scheme. TACE will be performed for the patients after randomization. Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE and I-125 Seeds Brachytherapy and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the TACE-AB-I arm, iodion-125 seeds will be implanted into the PVTT (according to the pre-operative planning) under CT guidance within 3-7 days after the first TACE. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multicenter, open-label trial, randomized controlled trial to evaluate the efficacy and safety of TACE-AB-I compared with TACE-AB for the treatment of HCC with branch PVTT.
| Arm | Type | Receives |
|---|---|---|
| TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I) | Experimental | Procedure: I-125 Seeds Brachytherapy in PVTT, Procedure: Transcatheter arterial chemoembolization, Drug: Atezolizumab plus BevacizumabTACE will be performed for the patients after randomization. Iodion-125 seeds will be implanted into the PVTT under CT guidance within 3-7 days after the first TACE. Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE and I-125 Seeds Brachytherapy. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination. |
| TACE and Atezolizumab/Bevacizumab (TACE-AB) | Active comparator | Procedure: Transcatheter arterial chemoembolization, Drug: Atezolizumab plus BevacizumabTACE will be performed for the patients after randomization. Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE. TACE can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between18 and 75 years;
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- Type I PVTT or type II PVTT;
- Child-Pugh class A;
- Eastern Cooperative Group performance status (ECOG) score of 0-1;
Key exclusion criteria (15 listed)
- Diffuse HCC;
- Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes (confirmed by histology, or pathology) are not eligible;
- Evidence of extrahepatic spread (EHS);
- Any condition representing a contraindication to TACE or I-125 seeds brachytherapy as determined by the investigators;
- Evidence or history of bleeding diathesis or any hemorrhage or bleeding event >CTCAE grade 3 within 4 weeks prior to randomization;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-125 Seeds Brachytherapy in PVTTAlso: Iodine-125 Seeds ImplantationIodine125 seed implantation into the PVTT was conducted 3-7 days after TACE when the results of the liver function tests were comparable to those obtained before TACE. Pre-procedural planning was conducted using a three-dimensional conformal radiation therapy treatment planning system (TPS) to determine the number of Iodine125 seeds required, the target location for implantation, the best percutaneous puncture site and the access route. The targeted zone for implantation was the tumour thrombosis in the segmental portal vein, left/right portal vein. Implantation was guided by CT, and the Iodine125 seeds were implanted into the PVTT using 18 G needles and the implantation gun that housed the Iodine125 seeds in the cartridge chamber. | Procedure or surgery | TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I) |
| Transcatheter arterial chemoembolizationAlso: TACETACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE). | Procedure or surgery | TACE and Atezolizumab/Bevacizumab (TACE-AB), TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I) |
| Atezolizumab plus BevacizumabAlso: atezolizumab-bevacizumab; Atez/Bev treatmentAtezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) . | Drug | TACE and Atezolizumab/Bevacizumab (TACE-AB), TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I) |
Primary outcome
Overall survival (OS)
Time frame: 2 years
Time from randomization to death from any cause.
4 secondary outcomes
Progression free survival (PFS)
Time frame: 2 years
Objective response rate (ORR)
Time frame: 2 years
Duration of portal patency
Time frame: 2 years
Adverse events (AEs)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No. Plan to share IPD with collaborators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mingsheng Huang, M.D. & Ph.D. principal investigator
Department of Interventional Radiology, The Third Affiliated Hospital of Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-125 Seeds Brachytherapy in PVTT, Transcatheter arterial chemoembolization and Atezolizumab plus Bevacizumab in people with Hepatocellular Carcinoma and Hepatic Portal Vein Tumor Invasion, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingsheng Huang, M.D. & Ph.D. (+86-02085253416, huangmsh@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.