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HCC - Hepatocellular CarcinomaPhase 2NCT07363512

Efficacy and Safety of Radiotherapy Combined With Tislelizumab and Anlotinib in the Treatment of Hepatocellular Carcinoma Complicated With Portal Vein Tumor Thrombus

A Phase 2 study testing Radiotherapy combined with tislelizumab and anlotinib in people with HCC - Hepatocellular Carcinoma, run by Henan Cancer Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

For HCC patients with PVTT who the researchers believe can benefit from radiotherapy combined with tislelizumab and anlotinib, informed consent forms will be signed, and then they will receive the study treatment and be followed up. The research design is as follows: First, radiotherapy was administered. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HCC - Hepatocellular Carcinoma
What is being tested?
Radiotherapy combined with tislelizumab and anlotinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
No sites listed yet
Study dates
5 Jan 2026to Nov 2028
Phase
Phase 2
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

  • Men aged between 18 and 75 or non-pregnant women;
  • Sign the informed consent form;
  • The researchers believe that the patients have the ability to comply with the research protocol;
  • Hepatocellular carcinoma (HCC) is diagnosed histologically, cytologically or clinically. Patients with liver cirrhosis are clinically diagnosed according to the AASLD standard, while non-liver cirrhosis patients need to be confirmed by histology.
  • Imaging examinations confirmed the presence of portal vein tumor thrombus;
  • The disease is not suitable for radical surgery;
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  • Has not received any anti-tumor treatment in the past;
  • At least one measurable (measurable according to RECIST1.1) untreated lesion;
  • Tumor tissue samples before treatment (if available). If tumor tissue is available, submit one formalin-fixed, paraffin-embedded (FFPE) tumor sample in a paraffin block (preferred), or approximately 10-15 slides containing unstained, freshly cut, series sections, along with a relevant pathological report within 4 weeks of enrollment. If the FFPE samples described above are not available, any type of sample (including fine needle aspiration biopsy samples and cell mass samples) can also be accepted. A relevant pathological report should be provided along with the sample.
  • The ECOG performance status score is 0 or 1;
  • Child-Pugh grade A;
  • Adequate hematology and organ function, based on the following laboratory test results obtained within 7 days before enrollment (unless otherwise specified) : absolute neutrophil count (ANC)≥1.5×109/L (1500/μL), no granulocyte colony-stimulating factor support; Lymphocyte count ≥0.5×109/L (500/μL); Platelet count ≥50×109/L (50,000 /μL), no blood transfusion; Hemoglobin ≥90 g/L (9g/dL);
  • Before enrollment, any acute and clinically significant treatment-related toxicity (caused by previous treatment) must have been alleviated to ≤ grade 1, except for alopecia.
  • The result of the HIV antibody test during screening was negative;
  • Patients with active hepatitis B virus (HBV) infection: HBV DNA obtained within 28 days before randomization < 2000IU/mL, and having received at least 14 days of anti-HBV treatment (treated according to local standard treatment, such as entecavir) before randomization and willing to continue treatment during the study period.

Who cannot join

  • Current or previous history of autoimmune diseases or immune deficiencies
  • History of meningitis;
  • Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., obliterative bronchiolitis), drug-induced pneumonia or idiopathic pneumonia, or evidence of active pneumonia can be seen on chest computed tomography (CT) images during the screening period. Radiation pneumonia has been allowed in the radiation area (fibrosis).
  • Known active tuberculosis;
  • Having major cardiovascular diseases (such as New York Heart Society Class II or more severe heart disease, myocardial infarction or cerebrovascular accident), unstable arrhythmia or unstable angina pectoris within 3 months prior to enrollment;
  • History of congenital long QT syndrome or corrected QT interval at screening >500ms (calculated using the Fridericia method);
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  • A history of uncorrectable electrolyte disorders such as serum potassium, calcium or magnesium;
  • Received major surgical treatment (excluding diagnosis) within 4 weeks before enrollment or is expected to require major surgical treatment during the study period;
  • Malignant tumors other than HCC that have occurred within 5 years prior to enrollment, excluding those with negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as well-treated cervical cancer in situ, non-melanoma skin cancer, localized prostate cancer, carcinoma in situ or stage I uterine cancer;
  • There was a severe infection within 4 weeks before enrollment, including but not limited to hospitalization due to infection, bacteremia or severe pneumonia complications;
  • Previous allogeneic stem cell or solid organ transplantation;
  • The patient cannot be followed up or is currently participating in other clinical trials;
  • Subjects who the researchers considered unsuitable for inclusion in this study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

jinxue Zhou contact

+86 13837175001

zhoujx888@126.com

About this study

For HCC patients with PVTT who the researchers believe can benefit from radiotherapy combined with tislelizumab and anlotinib, informed consent forms will be signed, and then they will receive the study treatment and be followed up. The research design is as follows:

First, radiotherapy was administered. Three days ±1 day after the start of radiotherapy, tislelizumab and anlotinib treatment were initiated. Each cycle was three weeks, and the treatment continued until no toxicity was acceptable or clinical benefits were lost (evaluated by the researcher based on imaging, biochemical indicators, and the patient's clinical status).

Being tested
Radiotherapy combined with tislelizumab and anlotinib
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiotherapy combined with tislelizumab and anlotinibCombination product

    Radiotherapy was performed using conventional fractionation. The PTV of the primary tumor and portal vein tumor thrombus was DT45-50Gy/25f, and the GTV was simultaneously pushed at DT50-60Gy/25f， Tislelizumab 200mg IV Q3W Anlotinib 12MG PO QD for two weeks followed by a one-week break Q3W

Study groups in NCT07363512
Study groupRoleWhat they receive
Radiotherapy combined with tislelizumab and anlotinibExperimentalNot described
Receives: Combination Product: Radiotherapy combined with tislelizumab and anlotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    The proportion of patients whose tumor volume has shrunk by more than 20% and can be maintained for more than 4 weeks.

    Measured: The time from the start of the first medication to the occurrence of tumor shrinkage or disappearance and maintaining it for more than 4 weeks (up to 36 months).

Secondary outcomes (6)

  1. Overall Survival

    Measured: up to 36 months

  2. Progression-Free Survival

    Measured: up to 36 months

  3. Disease Control Rate

    The percentage of patients whose tumors shrank or remained stable over a period of time.

    Measured: up to 36 months

  4. Duration of response

    Measured: up to 36 months

  5. Surgical resection rate

    After the treatment of portal vein tumor thrombus downstaging, the researchers evaluated that surgical resection was feasible, which was considered a successful transformation. The proportion of those who ultimately underwent resection was the conversion rate of surgical resection.

    Measured: up to 36 months

  6. adverse event

    Any adverse medical event that occurs to a patient or clinical trial subject after receiving a certain drug, but it does not necessarily have a causal relationship with the treatment.

    Measured: From the first treatment to 30 days after the end of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study start5 Jan 2026 (estimated)
  3. Primary completionMar 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

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
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07363512
Sponsor's protocol ID
2025-588-001
Status last verified
Jan 2026
First submitted
3 Jan 2026
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiotherapy combined with tislelizumab and anlotinib in people with HCC - Hepatocellular Carcinoma, run by Henan Cancer Hospital.

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 15 inclusion and 13 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: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

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 jinxue Zhou (+86 13837175001, zhoujx888@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: The time from the start of the first medication to the occurrence of tumor shrinkage or disappearance and maintaining it for more than 4 weeks (up to 36 months).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07363512.

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 23 Jan 2026.

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