Hepatocellular CarcinomaPhase 2NCT06233981
Phase II Study of Moderate-dose Hypofractionated RT Combined With Tislelizumab for HCC With Diffuse Tumor Thrombosis
A Phase 2 study testing Moderate-dose Hypofractionated Intensity-modulated Radiotherapy and Tislelizumab 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-center, single-arm, open-label study that includes patients meeting the inclusion criteria (liver-GTV volume < 700ml or estimated liver-GTV V5 < 300ml) with hepatocellular carcinoma with diffuse tumor thrombosis involving both left and right lobes. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hepatocellular Carcinoma, Radiotherapy, Tislelizumab
- What is being tested?
- Moderate-dose Hypofractionated Intensity-modulated Radiotherapy and Tislelizumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2024to 1 Jan 2026
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical or histological diagnosis of HCC with bilateral PVTT;
- Estimated Liver-GTV volume < 700ml or the estimated volume of liver minus GTV volume receiving less than 5 Gy of irradiation < 300ml;
- Age 18-90 years;
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
- Child-Pugh A5, A6, B7 and B8;
- Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 times upper limit of normal (ULN); or ALT ≤ 1.5 times ULN and AST ≤ 6 times ULN; TBIL < 60umol/L.
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- Creatinine (CRE) and blood urea nitrogen (BUN) < 2.5 ULN;
- Hb ≥ 50g/L, ANC ≥ 0.5 × 109/L, PLT ≥ 30 × 109 /L; patients with a history of gastrointestinal bleeding must be controlled for more than 2 weeks before enrollment with Hb ≥ 60g/L;
- 10. Voluntary to participate and sign informed consent.
Who cannot join
- Participating in other clinical trials currently;
- The history of abdominal irradiation;
- The history of liver transplantation;
- Known allergy to tislelizumab or lenvatinib;
- Pregnant, breast feeding, or unwilling to use adequate contraception;
- Serious myocardial disease or renal failure;
- Other serious diseases, such as alcohol and drug abuse or mental illness;
- Presence of other life-threatening malignancy within the last 3 years before enrollment (excluding superficial skin cancer, localized low-grade malignant tumor and carcinoma in situ).
Trial locations and contacts
1 site in 1 country.
China1 site
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College
Beijing
About this study
Official title: Phase II Study of Moderate-dose Hypofractionated Radiotherapy Combined With Tislelizumab for Hepatocellular Carcinoma With Diffuse Tumor Thrombosis Involved Both Left and Right Liver
This is a single-center, single-arm, open-label study that includes patients meeting the inclusion criteria (liver-GTV volume < 700ml or estimated liver-GTV V5 < 300ml) with hepatocellular carcinoma with diffuse tumor thrombosis involving both left and right lobes. All lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy, with a gross tumor dose of 25Gy/5f, and a maximum dose of 35Gy/5f at the tumor center. One week before or during the radiotherapy, patients receive concurrent Tislelizumab at a dose of 200mg. Subsequently, Tislelizumab is administered intravenously every 3 weeks. Follow-up examinations are conducted 1-3 months post-radiotherapy. Lenvatinib 4mg may be used for maintenance therapy with Tislelizumab if there are no contraindications. Maintenance therapy is continued until disease progression or intolerance. The primary endpoint is median overall survival (mOS), and secondary endpoints include objective response rate (ORR), progression-free survival (PFS), and toxicity.
- Conditions
- Hepatocellular Carcinoma, Radiotherapy, Tislelizumab, Tumor Thrombosis
- Being tested
- Moderate-dose Hypofractionated Intensity-modulated Radiotherapy, Tislelizumab
- Keywords
- Hepatocellular Carcinoma, Radiotherapy, Tislelizumab, Tumor Thrombosis
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-dose Hypofractionated Intensity-modulated RadiotherapyRadiation
All lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy, with a gross tumor dose of 25Gy/5f, and a maximum dose of 35Gy/5f at the tumor center.
TislelizumabDrug
One week before or during the radiotherapy, patients receive concurrent Tislelizumab at a dose of 200mg. Subsequently, Tislelizumab is administered intravenously every 3 weeks. Follow-up examinations are conducted 1-3 months post-radiotherapy. Lenvatinib 4mg may be used for maintenance therapy with Tislelizumab, which may be escalated up to a maximum of 12 mg per day, until disease progression or intolerance or death.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy and Tislelizumab | Experimental | Moderate-dose hypofractionated intensity-modulated radiotherapy with a gross tumor dose of 25Gy/5f and a maximum dose of 35Gy/5f at the tumor center concurrent with Tislelizumab, followed Tislelizumab±lenvatinib for maintenance. Receives: Radiation: Moderate-dose Hypofractionated Intensity-modulated Radiotherapy; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Overall Survival
Median Overall Survival (mOS) is defined as the median of Overall Survival (OS). OS is defined as the time from the end of radiotherapy to death from any cause
Measured: 24 months
Secondary outcomes (3)
Objective Response Rate
Treatment response was defined as the best response in 3 months after radiotherapy. ORR is defined as the percentage of patients who met the complete response (CR) or partial response (PR) criteria as defined by the modified Response Evaluation Criteria in Solid Tumors (mRECIST) and RECIST 1.1
Measured: Assessment in 1 to 3 months after radiotherapy
Progression-free Survival
Progression-free Survival (PFS) is defined as the time from the end of RT until tumor progression or death from any cause.
Measured: 24 months
Toxicity
Toxicity is assessed and graded according to the Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0).
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 posted31 Jan 2024
- Study start25 Jan 2024
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
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
- 30 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
- NCT06233981
- Sponsor's protocol ID
- NCC4247
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Moderate-dose Hypofractionated Radiotherapy Combined With Tislelizumab for Hepatocellular Carcinoma With Diffuse Tumor Thrombosis Involved Both Left and Right Liver
- ClinicalTrials.gov ID
- NCT06233981
- Acronym / sponsor ID
- NCC4247
- Conditions
- Hepatocellular Carcinoma, Radiotherapy, Tislelizumab, Tumor Thrombosis
- Keywords
- Hepatocellular Carcinoma, Radiotherapy, Tislelizumab, Tumor Thrombosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 31 Jan 2024 (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-center, single-arm, open-label study that includes patients meeting the inclusion criteria (liver-GTV volume < 700ml or estimated liver-GTV V5 < 300ml) with hepatocellular carcinoma with diffuse tumor thrombosis involving both left and right lobes. All lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy, with a gross tumor dose of 25Gy/5f, and a maximum dose of 35Gy/5f at the tumor center. One week before or during the radiotherapy, patients receive concurrent Tislelizumab at a dose of 200mg. Subsequently, Tislelizumab is administered intravenously every 3 weeks. Follow-up examinations are conducted 1-3 months post-radiotherapy. Lenvatinib 4mg may be used for maintenance therapy with Tislelizumab if there are no contraindications. Maintenance therapy is continued until disease progression or intolerance. The primary endpoint is median overall survival (mOS), and secondary endpoints include objective response rate (ORR), progression-free survival (PFS), and toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy and Tislelizumab | Experimental | Radiation: Moderate-dose Hypofractionated Intensity-modulated Radiotherapy, Drug: TislelizumabModerate-dose hypofractionated intensity-modulated radiotherapy with a gross tumor dose of 25Gy/5f and a maximum dose of 35Gy/5f at the tumor center concurrent with Tislelizumab, followed Tislelizumab±lenvatinib for maintenance. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinical or histological diagnosis of HCC with bilateral PVTT;
- Estimated Liver-GTV volume < 700ml or the estimated volume of liver minus GTV volume receiving less than 5 Gy of irradiation < 300ml;
- Age 18-90 years;
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
- Child-Pugh A5, A6, B7 and B8;
Key exclusion criteria (8 listed)
- Participating in other clinical trials currently;
- The history of abdominal irradiation;
- The history of liver transplantation;
- Known allergy to tislelizumab or lenvatinib;
- Pregnant, breast feeding, or unwilling to use adequate contraception;
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 |
|---|---|---|
| Moderate-dose Hypofractionated Intensity-modulated RadiotherapyAll lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy, with a gross tumor dose of 25Gy/5f, and a maximum dose of 35Gy/5f at the tumor center. | Radiation | Radiotherapy and Tislelizumab |
| TislelizumabOne week before or during the radiotherapy, patients receive concurrent Tislelizumab at a dose of 200mg. Subsequently, Tislelizumab is administered intravenously every 3 weeks. Follow-up examinations are conducted 1-3 months post-radiotherapy. Lenvatinib 4mg may be used for maintenance therapy with Tislelizumab, which may be escalated up to a maximum of 12 mg per day, until disease progression or intolerance or death. | Drug | Radiotherapy and Tislelizumab |
Primary outcome
Median Overall Survival
Time frame: 24 months
Median Overall Survival (mOS) is defined as the median of Overall Survival (OS). OS is defined as the time from the end of radiotherapy to death from any cause
3 secondary outcomes
Objective Response Rate
Time frame: Assessment in 1 to 3 months after radiotherapy
Progression-free Survival
Time frame: 24 months
Toxicity
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 17 Apr 2026.
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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 Moderate-dose Hypofractionated Intensity-modulated Radiotherapy and Tislelizumab 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 9 inclusion and 8 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 17 Apr 2026. 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?
Median Overall Survival (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 17 Apr 2026.