TislelizumabEarly Phase 1NCT05131698
Clinical Study of the Efficacy and Safety of Transhepatic Arterial Chemoembolization Combined With Tislelizumab and Lenvatinib in Patients With Advanced Unresectable Hepatocellular Carcinoma
A Early Phase 1 study testing Tislelizumab and Lenvatinib in people with Tislelizumab and Lenvatinib, run by Cancer Hospital of Guangxi Medical University at 1 site in China.
Trial summary
ICIs combined with AATDs have gradually become the mainstream treatment modality for advanced hepatocellular carcinoma, and more related clinical trials are underway. This is undoubtedly a breakthrough and the main direction for improving the overall 5-year survival rate of the liver cancer population in the next… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tislelizumab, Lenvatinib, TACE
- What is being tested?
- Tislelizumab and Lenvatinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 5 Jul 2024
- Phase
- Early Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Advanced Unresectable Hepatocellular Carcinoma
- Histological examination or clinical diagnosis of HCC
- BCLC C Stage
- Child-Pugh A
- ECOG 0-1
- Age ≥ 18 years old and ≤ 70 years old
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- No serious concomitant diseases
- No Portal vein tumor thrombus or Inferior vena cava tumor thrombus
- No extrahepatic metastases
- Not receiving any systematic treatment
- life expectancy > 3 months.
- The patient must be able to understand and be willing to sign a written informed consent form.
Who cannot join
- previous (within 5 years) or concurrent other malignancies
- participated in a clinical trial of another drug within four weeks
- the presence of a contraindication to TACE
- There is a history of bleeding, and any bleeding event with a severe grade of 3 or above in CTCAE v5.0 occurred within 4 weeks before screening
- Patients with known CNS metastases or a history of CNS metastases prior to screening. For patients with clinically suspected CNS metastases, CT or MRI must be performed within 28 days prior to enrolment to exclude CNS metastases.
- patients with a history of unstable angina pectoris; those with newly diagnosed angina pectoris within 3 months prior to screening or a myocardial infarction event within 6 months prior to screening; arrhythmias (including QTcF: ≥ 450 ms in men and ≥ 470 ms in women) requiring long-term antiarrhythmic medication and New York Heart Association classification ≥ Class II cardiac insufficiency.
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- Have a history of immunodeficiency, or suffer from other acquired and congenital immunodeficiency diseases, or have received allogeneic stem cell transplantation or organ transplantation in the past.
- patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other conditions requiring the use of corticosteroids.
- Have a serious history of chronic autoimmune diseases, such as systemic lupus erythematosus. Well-controlled immune-related diseases, such as dermatitis, psoriasis and rheumatoid arthritis, can be included in the group after being evaluated by researchers.
- There is a history of inflammatory bowel diseases such as ulcerative enteritis and Crohn's disease, and a history of inflammatory chronic diarrhea diseases such as irritable bowel syndrome.
- Have a history of sarcoidosis or tuberculosis.
- Known history of human immunodeficiency virus (HIV) infection.
- patients with hypersensitivity to human or murine monoclonal antibodies.
- persons with a history of psychotropic substance abuse who are unable to abstain or who have a psychiatric disorder.
- patients with clinical signs of pleural effusion or peritoneal effusion requiring clinical intervention.
- patients with concomitant illnesses that, in the judgment of the investigator, seriously jeopardize patient safety or interfere with patient completion of the study.
- pregnant and lactating females.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, 530000
About this study
ICIs combined with AATDs have gradually become the mainstream treatment modality for advanced hepatocellular carcinoma, and more related clinical trials are underway. This is undoubtedly a breakthrough and the main direction for improving the overall 5-year survival rate of the liver cancer population in the next decade, and a touchstone for exploring the development and value of liver surgery in the era of comprehensive treatment for advanced hepatocellular carcinoma.
Overall, there are relatively few reports on various types of translational therapy for advanced HCC, probably for the following two reasons: (1) advanced hepatocellular carcinoma is complex, rapidly progressing, difficult to treat, and has low translational efficiency; (2) the existing translational therapy strategies are highly selective in terms of applicable population, complex treatment process, and institutional dependence, and cannot achieve efficient and successful translation.
At present, there are few studies reported on the application of TACE+ICIs+AATDs to carry out translational therapy. In the absence of relevant guidelines for reference, advanced hepatocellular carcinoma may be the best entrance to carry out translational therapy with ICIs combined with AATDs, and after satisfactory results are achieved in the treatment of this group of patients, a point-to-point effect can be generated, facilitating the transformation of TACE+ICIs+AATDs The target population of TACE+ICIs+AATDs translational therapy can be further expanded. To promote the development of hepatocellular carcinoma treatment and improve the long-term survival rate of the overall hepatocellular carcinoma population. In this study, we enrolled patients with advanced HCC and used TACE+ICIs+AATDs for conversion therapy to improve the conversion rate, so that unresectable HCC patients could be converted to a chronic disease state and achieve long-term survival on the one hand, and provide potential for sequential surgical treatment on the other. The drug of choice is lenvatinib. This study provides a basis for the clinical application of translational therapy for advanced hepatocellular carcinoma.
- Being tested
- Tislelizumab and Lenvatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab and LenvatinibCombination product
Also called Clinical Study of the Efficacy and Safety of Transhepatic Arterial Chemoembolization Combined With Tislelizumab and Lenvatinib in Patients With Advanced Unresectable Hepatocellular Carcinoma
TACE therapy: For transarterial infusion chemotherapy before or after TACE embolization, each drug will generally be diluted with 0.9% sodium chloride solution or 5% dextrose solution 150-250 mL and injected slowly into the target artery for ≥20 min. Subsequent TACE therapy will be administered on an as-needed basis as assessed by the clinician, with each treatment interval exceeding 6 weeks and no more than 6 treatments in total.
Lenvatinib: The starting dose of lenvatinib will depend on the patient's baseline weight: if baseline weight ≥ 60 kg, patients will receive 12 mg of lenvatinib administered once daily; if baseline weight < 60 kg, patients will receive 8 mg of lenvatinib once daily. TACE therapy will be given 3 days apart.
Tirelizumab: Tirelizumab 200 mg , intravenous infusion on the same day as the first dose of lenvatinib, once every three weeks.
Translated with www.DeepL.com/Translator (free version)
| Study group | Role | What they receive |
|---|---|---|
| Patients with advanced unresectable liver cancer | Experimental | Not described Receives: Combination Product: Tislelizumab and Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Refers to cases in which the objective tumor outcome, including CR and PR, was assessed using the mRECIST version of the criteria
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start1 Mar 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion5 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TislelizumabStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi-ming Zhang, Cancer Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131698
- Sponsor's protocol ID
- CS2021（94）
- Status last verified
- Jan 2023
- First submitted
- 4 Nov 2021
- Last updated
- 26 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nong X, Yao Y, Xie J, Liang J, Zhang Y, Zhang Z. Preliminary experience of lenvatinib, tislelizumab and transcatheter arterial chemoembolization for BCLC stage C hepatocellular carcinoma: a phase II study. BMC Cancer. 2025 Oct 22;25(1):1631. doi: 10.1186/s12885-025-15016-9.
PubMed 41126100
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Efficacy and Safety of Transhepatic Arterial Chemoembolization Combined With Tislelizumab and Lenvatinib in Patients With Advanced Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05131698
- Acronym / sponsor ID
- CS2021（94）
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Cancer Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 5 Jul 2024 (estimated)
- First posted
- 23 Nov 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.
ICIs combined with AATDs have gradually become the mainstream treatment modality for advanced hepatocellular carcinoma, and more related clinical trials are underway. This is undoubtedly a breakthrough and the main direction for improving the overall 5-year survival rate of the liver cancer population in the next decade, and a touchstone for exploring the development and value of liver surgery in the era of comprehensive treatment for advanced hepatocellular carcinoma.
Overall, there are relatively few reports on various types of translational therapy for advanced HCC, probably for the following two reasons: (1) advanced hepatocellular carcinoma is complex, rapidly progressing, difficult to treat, and has low translational efficiency; (2) the existing translational therapy strategies are highly selective in terms of applicable population, complex treatment process, and institutional dependence, and cannot achieve efficient and successful translation.
At present, there are few studies reported on the application of TACE+ICIs+AATDs to carry out translational therapy. In the absence of relevant guidelines for reference, advanced hepatocellular carcinoma may be the best entrance to carry out translational therapy with ICIs combined with AATDs, and after satisfactory results are achieved in the treatment of this group of patients, a point-to-point effect can be generated, facilitating the transformation of TACE+ICIs+AATDs The target population of TACE+ICIs+AATDs translational therapy can be further expanded. To promote the development of hepatocellular carcinoma treatment and improve the long-term survival rate of the overall hepatocellular carcinoma population. In this study, we enrolled patients with advanced HCC and used TACE+ICIs+AATDs for conversion therapy to improve the conversion rate, so that unresectable HCC patients could be converted to a chronic disease state and achieve long-term survival on the one hand, and provide potential for sequential surgical treatment on the other. The drug of choice is lenvatinib. This study provides a basis for the clinical application of translational therapy for advanced hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with advanced unresectable liver cancer | Experimental | Combination Product: Tislelizumab and Lenvatinib |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Advanced Unresectable Hepatocellular Carcinoma
- Histological examination or clinical diagnosis of HCC
- BCLC C Stage
- Child-Pugh A
- ECOG 0-1
Key exclusion criteria (17 listed)
- previous (within 5 years) or concurrent other malignancies
- participated in a clinical trial of another drug within four weeks
- the presence of a contraindication to TACE
- There is a history of bleeding, and any bleeding event with a severe grade of 3 or above in CTCAE v5.0 occurred within 4 weeks before screening
- Patients with known CNS metastases or a history of CNS metastases prior to screening. For patients with clinically suspected CNS metastases, CT or MRI must be performed within 28 days prior to enrolment to exclude CNS metastases.
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 |
|---|---|---|
| Tislelizumab and LenvatinibAlso: Clinical Study of the Efficacy and Safety of Transhepatic Arterial Chemoembolization Combined With Tislelizumab and Lenvatinib in Patients With Advanced Unresectable Hepatocellular CarcinomaTACE therapy: For transarterial infusion chemotherapy before or after TACE embolization, each drug will generally be diluted with 0.9% sodium chloride solution or 5% dextrose solution 150-250 mL and injected slowly into the target artery for ≥20 min. Subsequent TACE therapy will be administered on an as-needed basis as assessed by the clinician, with each treatment interval exceeding 6 weeks and no more than 6 treatments in total. Lenvatinib: The starting dose of lenvatinib will depend on the patient's baseline weight: if baseline weight ≥ 60 kg, patients will receive 12 mg of lenvatinib administered once daily; if baseline weight < 60 kg, patients will receive 8 mg of lenvatinib once daily. TACE therapy will be given 3 days apart. Tirelizumab: Tirelizumab 200 mg , intravenous infusion on the same day as the first dose of lenvatinib, once every three weeks. Translated with www.DeepL.com/Translator (free version) | Combination product | Patients with advanced unresectable liver cancer |
Primary outcome
Objective response rate
Time frame: 1 year
Refers to cases in which the objective tumor outcome, including CR and PR, was assessed using the mRECIST version of the criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 41126100Nong X, Yao Y, Xie J, Liang J, Zhang Y, Zhang Z. Preliminary experience of lenvatinib, tislelizumab and transcatheter arterial chemoembolization for BCLC stage C hepatocellular carcinoma: a phase II study. BMC Cancer. 2025 Oct 22;25(1):1631. doi: 10.1186/s12885-025-15016-9.
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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 Early Phase 1 study testing Tislelizumab and Lenvatinib in people with Tislelizumab and Lenvatinib, run by Cancer Hospital of Guangxi Medical 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 12 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 26 Jan 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Objective response rate (time frame: 1 year). 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 NCT05131698, which also lists 1 linked publication.
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 26 Jan 2023.