Hepatocellular CarcinomaNCT07052448
The Efficacy of Sequential RT After Triple Therapy for uHCC
An observational study of Hepatocellular Carcinoma, run by Fujian Provincial Hospital at 1 site in China.
Trial summary
Triple therapy of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodies has demonstrated excellent efficacy in unresectable hepatocellular carcinoma (uHCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- sequential radiotherapy after the combination of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodies
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 30 Jun 2026
- Phase
- Observational
- 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
Study population: Patients with unresectable hepatocellular carcinoma received sequential radiotherapy after the combination of transcatheter arterial chemoembolization with lenvatinib and anti-PD-1 antibodies.
Who may be able to join
- Patients diagnosed with HCC and assessed as unresectable by multidisciplinary team (MDT)
- Patients who achieved PR or SD after triple therapy according to the mRECIST and did not meet the criteria for radical surgical resection or could not tolerate surgical treatment
- Patients who received sequential radiotherapy
- Age between 18 and 75 years
- Child-Pugh class A or B
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1
Who cannot join
- Previous acceptance of other antitumor treatments
- Treatment in conjunction with other treatment regimens, such as radiofrequency ablation and chemotherapy
- History of other malignancies
- Incomplete data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Efficacy of Sequential Radiotherapy After the Combination of Transcatheter Arterial Chemoembolization With Lenvatinib and Anti-PD-1 Antibodies for Unresectable Hepatocellular Carcinoma
Triple therapy of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodies has demonstrated excellent efficacy in unresectable hepatocellular carcinoma (uHCC). However, tumor drug resistance is still a major problem and many patients fail to achieve complete necrosis of the lesions after treatment. This study aimed to investigate the efficacy and safety of sequential radiotherapy after triple therapy in patients with uHCC to improve tumor response rate.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- sequential radiotherapy after the combination of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodies
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sequential radiotherapy after the combination of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodiesDrug
sequential radiotherapy after the combination of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodies
| Study group | Role | What they receive |
|---|---|---|
| sequential radiotherapy after triple therapy | Patients with unresectable hepatocellular carcinoma received sequential radiotherapy after the combination of transcatheter arterial chemoembolization with lenvatinib and anti-PD-1 antibodies Receives: Drug: sequential radiotherapy after the combination of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
overall survival
Measured: From date of randomization until the date of date of death from any cause or the most recent follow-up, whichever came first, assessed up to 100 months
Secondary outcomes (2)
PFS
progression-free survival
Measured: From date of randomization until the date of first documented progression, the date of death from any cause or the date of most recent follow-up, whichever came first, assessed up to 100 months
ORR
objective response rate
Measured: From date of randomization until the date of the best tumor response is achieved, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start1 Nov 2020
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Jun 2026 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mao-Lin Yan, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052448
- Sponsor's protocol ID
- TALENP006
- Status last verified
- Jun 2025
- First submitted
- 21 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are not publicly available due to privacy reasons but are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Sequential Radiotherapy After the Combination of Transcatheter Arterial Chemoembolization With Lenvatinib and Anti-PD-1 Antibodies for Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07052448
- Acronym / sponsor ID
- TALENP006
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 4 Jul 2025 (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.
Triple therapy of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodies has demonstrated excellent efficacy in unresectable hepatocellular carcinoma (uHCC). However, tumor drug resistance is still a major problem and many patients fail to achieve complete necrosis of the lesions after treatment. This study aimed to investigate the efficacy and safety of sequential radiotherapy after triple therapy in patients with uHCC to improve tumor response rate.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sequential radiotherapy after triple therapy | – | Drug: sequential radiotherapy after the combination of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodiesPatients with unresectable hepatocellular carcinoma received sequential radiotherapy after the combination of transcatheter arterial chemoembolization with lenvatinib and anti-PD-1 antibodies |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unresectable hepatocellular carcinoma received sequential radiotherapy after the combination of transcatheter arterial chemoembolization with lenvatinib and anti-PD-1 antibodies.
Key inclusion criteria (6 listed)
- Patients diagnosed with HCC and assessed as unresectable by multidisciplinary team (MDT)
- Patients who achieved PR or SD after triple therapy according to the mRECIST and did not meet the criteria for radical surgical resection or could not tolerate surgical treatment
- Patients who received sequential radiotherapy
- Age between 18 and 75 years
- Child-Pugh class A or B
Key exclusion criteria (4 listed)
- Previous acceptance of other antitumor treatments
- Treatment in conjunction with other treatment regimens, such as radiofrequency ablation and chemotherapy
- History of other malignancies
- Incomplete data.
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 |
|---|---|---|
| sequential radiotherapy after the combination of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodiessequential radiotherapy after the combination of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodies | Drug | sequential radiotherapy after triple therapy |
Primary outcome
OS
Time frame: From date of randomization until the date of date of death from any cause or the most recent follow-up, whichever came first, assessed up to 100 months
overall survival
2 secondary outcomes
PFS
Time frame: From date of randomization until the date of first documented progression, the date of death from any cause or the date of most recent follow-up, whichever came first, assessed up to 100 months
ORR
Time frame: From date of randomization until the date of the best tumor response is achieved, assessed up to 100 months
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 4 Jul 2025.
- Individual participant dataSharing planned: No. The data that support the findings of this study are not publicly available due to privacy reasons but are available from the corresponding author upon reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Fujian Provincial Hospital 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 6 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 4 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: From date of randomization until the date of date of death from any cause or the most recent follow-up, whichever came first, assessed up to 100 months). 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 4 Jul 2025.