Hepatocellular CarcinomaPhase 2NCT04791176
Phase II Study of Concurrent Lenvatinib and Radiotherapy for Advanced HCC
A Phase 2 study testing concurrent lenvatinib and Radiotherapy, followed lenvatinib maintenance in people with Hepatocellular Carcinoma and Radiotherapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a single-arm, open-label study performed at our hospital, patients with progression hepatocellular carcinoma (HCC) met inclusion criteria will be enrolled. Patients received oral lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients<60kg ) before local radiotherapy 4 weeks, large lesions were… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma, Radiotherapy, Lenvatinib
- What is being tested?
- concurrent lenvatinib and Radiotherapy, followed lenvatinib maintenance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2021to 23 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients had an HCC diagnosis confirmed either histologically or clinically according to the Chinese Society of Clinical Oncology guidelines for primary liver cancer 2019 version；
- Aged ≥18 years and <80 years；
- ECOG 0-1;
- Live-GTV volume > 700ml;
- BCLC stage C, HCC with portal vein or hepatic vein tumor thrombosis or lymph node involved (LN involved can be included one treatment planning);
- Estimated life expectancy should be more than 3 months;
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- Patients with lung and / or bone metastases can be enrolled if those metastases couldn't effect the patients' life and quality of life within 3 months;
- Child-Pugh Score A5,A6,B7;
- Liver function: ALT is less than 1.5 times of the upper limit of normal; ALT is less than 0.5 times of the upper limit of normal, AST can be less than 6 times of the upper limit of normal, excluding the elevation of AST caused by heart infarction; ALT is 0.5 to 1.5 times of the upper limit of normal, AST is less than 1.5 times of the upper limit of normal;
- ECG examination showed no obvious abnormality, no obvious cardiac dysfunction;
- Renal function: CRE and BUN were within 1.5 times of the upper limit of normal value;
- Blood routine: HB ≥ 80g / L, ANC ≥ 1.0 × 109 / L, PLT ≥ 40 × 109 / L;
- Coagulation function: no bleeding tendency;
- Informed and voluntarily participated in the study and signed informed consent.
Who cannot join
- Currently in the process of other clinical trials within recently four weeks;
- Previous abdominal radiotherapy and liver transplantation;
- Patients with severe chronic diseases of heart, kidney, liver and other important organs;
- Pregnant or lactating women;
- Suspected or indeed drug abusers, drug abusers and alcoholics;
- Allergic to lenvatinib or other treatments.
- Severe mental or nervous system disorders affecting informed consent and / or expression or observation of adverse reaction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Concurrent Lenvatinib and Intensity-modulated Radiotherapy (IMRT) for Advanced Hepatocellular Carcinoma
This is a single-arm, open-label study performed at our hospital, patients with progression hepatocellular carcinoma (HCC) met inclusion criteria will be enrolled. Patients received oral lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients<60kg ) before local radiotherapy 4 weeks, large lesions were treated with IMRT for 40-60gy / 20-30f. Combined therapy will be taken until unacceptable treatment-related toxicities occurred or disease progression.
- Conditions
- Hepatocellular Carcinoma, Radiotherapy, Lenvatinib
- Being tested
- concurrent lenvatinib and Radiotherapy, followed lenvatinib maintenance
- Keywords
- hepatocellular carcinoma, intensity-modulated radiotherapy, portal vein thrombosis, lymph node metastasis, Lenvatinib
- Medical subject headings
- Carcinoma, Hepatocellular, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concurrent lenvatinib and Radiotherapy, followed lenvatinib maintenanceRadiation
Radiotherapy with IMRT or VMAT with 40-60Gy/20-30f; Concurrent Lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients<60kg ) qd po. (Note: Levatinib can be given to patients in four weeks before Radiotherapy is applied, so that it can control disease during waiting for Radiotherapy). Maintenance Lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients<60kg ) qd po until disease progress or unacceptable adverse events; six months is recommended but not mandatory.
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib and IMRT | Experimental | Concurrent Lenvatinib and IMRT, followed Lenvatinib maintenance for advanced hepatocellular carcinoma with portal vein or hepatic vein tumor thrombosis or lymph node involved Receives: Radiation: concurrent lenvatinib and Radiotherapy, followed lenvatinib maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
MST
Median Survival Time (MST) was defined as the duration from the date of patient recruited to the date of death from any cause
Measured: 24 months
Secondary outcomes (3)
ORR
Overall Response Rate (ORR) was defined as the total of CR (Complete Response) and PR (Partial Response). CR and PR were assessed by independent reviewers according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR evaluated in 1 to 3 months after the completion of radiotherapy.
Measured: Assessment in 1 to 3 months after radiotherapy
TTP
Time to Progression (TTP) was defined as the duration from the date of patient recruited to the first progress at any site or the date of death
Measured: 24 months
Rate of III-IV grade adverse events
Adverse events was evaluated during received protocol therapy according to CTCAE 4.03
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start12 Apr 2021
- Primary completion30 Jun 2024
- Study completion23 May 2025
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.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BO CHEN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791176
- Sponsor's protocol ID
- NCC2508
- Status last verified
- Aug 2025
- First submitted
- 6 Mar 2021
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Concurrent Lenvatinib and Intensity-modulated Radiotherapy (IMRT) for Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04791176
- Acronym / sponsor ID
- NCC2508
- Conditions
- Hepatocellular Carcinoma, Radiotherapy, Lenvatinib
- Keywords
- hepatocellular carcinoma, intensity-modulated radiotherapy, portal vein thrombosis, lymph node metastasis, Lenvatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 10 Mar 2021 (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.
This is a single-arm, open-label study performed at our hospital, patients with progression hepatocellular carcinoma (HCC) met inclusion criteria will be enrolled. Patients received oral lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients<60kg ) before local radiotherapy 4 weeks, large lesions were treated with IMRT for 40-60gy / 20-30f. Combined therapy will be taken until unacceptable treatment-related toxicities occurred or disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib and IMRT | Experimental | Radiation: concurrent lenvatinib and Radiotherapy, followed lenvatinib maintenanceConcurrent Lenvatinib and IMRT, followed Lenvatinib maintenance for advanced hepatocellular carcinoma with portal vein or hepatic vein tumor thrombosis or lymph node involved |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients had an HCC diagnosis confirmed either histologically or clinically according to the Chinese Society of Clinical Oncology guidelines for primary liver cancer 2019 version；
- Aged ≥18 years and <80 years；
- ECOG 0-1;
- Live-GTV volume > 700ml;
- BCLC stage C, HCC with portal vein or hepatic vein tumor thrombosis or lymph node involved (LN involved can be included one treatment planning);
Key exclusion criteria (7 listed)
- Currently in the process of other clinical trials within recently four weeks;
- Previous abdominal radiotherapy and liver transplantation;
- Patients with severe chronic diseases of heart, kidney, liver and other important organs;
- Pregnant or lactating women;
- Suspected or indeed drug abusers, drug abusers and alcoholics;
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 |
|---|---|---|
| concurrent lenvatinib and Radiotherapy, followed lenvatinib maintenanceRadiotherapy with IMRT or VMAT with 40-60Gy/20-30f; Concurrent Lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients<60kg ) qd po. (Note: Levatinib can be given to patients in four weeks before Radiotherapy is applied, so that it can control disease during waiting for Radiotherapy). Maintenance Lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients<60kg ) qd po until disease progress or unacceptable adverse events; six months is recommended but not mandatory. | Radiation | Lenvatinib and IMRT |
Primary outcome
MST
Time frame: 24 months
Median Survival Time (MST) was defined as the duration from the date of patient recruited to the date of death from any cause
3 secondary outcomes
ORR
Time frame: Assessment in 1 to 3 months after radiotherapy
TTP
Time frame: 24 months
Rate of III-IV grade adverse events
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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?
A Phase 2 study testing concurrent lenvatinib and Radiotherapy, followed lenvatinib maintenance in people with Hepatocellular Carcinoma and Radiotherapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 14 inclusion and 7 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: finished, as of the sponsor's last update on 14 Aug 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MST (time frame: 24 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 14 Aug 2025.