Hepatocellular CarcinomaPhase 1/2NCT05842317
Lenvatinib Plus Tislelizumab With or Without TACE in First-line Treatment of Unresectable HCC
A Phase 1/2 study testing Lenvatinib Plus Tislelizumab and Transarterial Chemoembolization(TACE) in people with Hepatocellular Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
To explore the effects of lenvatinib in combination with tislelizumab with or without TACE in patients with hepatocellular carcinoma on survival, disease progression, and medication safety. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Lenvatinib Plus Tislelizumab and Transarterial Chemoembolization(TACE)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 15 Nov 2024
- Phase
- Phase 1/2
- 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
- Participants must meet all of the following criteria to be included:
- Participants must voluntarily agree to participate in the study and provide written informed consent, be compliant, and agree to follow-up.
- Participants must be between 18 and 80 years old, regardless of gender, at the time of signing the informed consent form.
- Participants must be diagnosed with hepatocellular carcinoma by imaging (according to AASLD criteria or the 2022 National Health Commission Guidelines for the Diagnosis and Treatment of Liver Cancer) or histological or cytological examination.
- Patients with advanced liver cancer: patients who are in BCLC stage C or B and are eligible for TACE treatment.
- Participants must not have received systemic treatment.
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- There must be at least one measurable lesion (according to RECIST 1.1 criteria, the measurable lesion must have a spiral CT scan long diameter ≥10 mm or an enlarged lymph node short diameter ≥15 mm).
- ECOG performance status must be 0-1 point within 1 week before enrollment.
- Child-Pugh liver function grade: Class A (5-6 points).
- Expected survival time ≥3 months.
- Active hepatitis B or C patients must receive relevant antiviral treatment, with HBV-DNA <2500 IU/mL (<105 copies/mL) and have received antiviral treatment for at least 14 days before participating in the study. HCV RNA-positive patients must be treated according to local standard treatment guidelines and have liver function increased no more than Grade 1 in CTCAE during treatment.
- Hematological and organ function must be adequate, based on laboratory test results obtained within 14 days before starting the study treatment, unless otherwise specified:
- Complete blood count: (not transfused, not treated with G-CSF or drugs for correction) white blood cell count ≥ 3.0 x 109/L, Hb ≥ 90 g/L, neutrophil count ≥ 1.5 × 109/L, and platelet count ≥ 60 × 109/L.
- Biochemical tests: (not given albumin in the last 14 days)
- Appropriate liver function: ALB ≥ 29 g/L, ALP, ALT, and AST <5 × ULN, TBIL ≤ 3 × ULN, and PT prolongation time no more than 6s of ULN
- Appropriate renal function: Creatinine ≤ 1.5 × ULN, or creatinine clearance (CCr) >50 mL/min (using the Cockcroft-Gault formula):
- Female: CrCl = ((140 - age) × body weight (kg) × 0.85) / 72 × serum creatinine (mg/dL) Male: CrCl = ((140 - age) × body weight (kg) × 1.00) / 72 × serum creatinine (mg/dL)
- Women of childbearing potential: must agree to abstain from sexual activity or use a contraceptive method with a failure rate of less than 1% for at least 6 months during the treatment period and after the last dose.
- If a female patient has menstruated and has not yet reached postmenopausal status (no menstrual periods for ≥12 months continuously, and no other causes for menopause except surgical sterilization), and has not undergone sterilization surgery (removal of the ovaries and/or uterus), she is considered to be of childbearing potential.
Who cannot join
- Patients with hepatocellular carcinoma who have one or more of the following:
- Suitable for surgical treatment;
- Already underwent radical surgery with no assessable lesions;
- A history of liver transplantation or are preparing for liver transplantation.
- ECOG score ≥ 2 points.
- History of hepatic encephalopathy.
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- Patients who have received systemic treatment in the past.
- Histological types of cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma, and squamous cell carcinoma.
- Pregnant (positive pregnancy test before medication) or lactating women. Known allergy or intolerance to recombinant humanized PD-1 monoclonal antibody drugs or lenvatinib and its components (or any excipient).
- Received local anti-tumor treatment within 4 weeks before the first study drug treatment, including but not limited to surgery, radiotherapy, hepatic artery embolization, TACE, hepatic artery infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection (palliative radiotherapy for bone metastases at least 2 weeks before study drug treatment is allowed);
- Past or current grade 3 or above digestive fistula or non-digestive fistula (such as skin) according to the CTCAE 5.0 standard.
- Various factors affecting oral administration of lenvatinib, such as inability to swallow, chronic diarrhea and intestinal obstruction, or other conditions that significantly affect drug intake and absorption.
- Clinically significant ascites (i.e., Child-Pugh score for ascites>2) or malignant ascites that require therapeutic abdominal paracentesis or drainage; or uncontrolled malignant ascites (as determined by the investigator) that cannot be controlled by diuretics or puncture.
- Major surgery (except biopsy) performed within 4 weeks before the first study drug treatment or surgical incision that has not completely healed; minor surgery (such as simple excision, biopsy, etc.) within 7 days before the first study intervention.
- Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, cerebrovascular accident or transient ischemic attack, congestive heart failure (New York Heart Association classification ≥2, see Appendix 4); arrhythmia requiring antiarrhythmic drugs (other than beta blockers or digoxin) for treatment; repeat electrocardiogram showing QTcF interval > 480 milliseconds (ms).
- Hepatic or renal dysfunction, such as jaundice, ascites, and/or bilirubin > 3 × ULN, creatinine ratio > 3.5 g/24 hours, or renal failure requiring blood or peritoneal dialysis. Urinalysis showing urinary protein ≥++ or confirmed 24-hour urinary protein quantification> 1.0g.
- Persistent infection of grade >2 (CTC-AE 5.0) in the past 6 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nan Zhang
Beijing, Beijing Municipality, 100730
Nan Zhang, M.D., +8615600802833, zhnan123@hotmail.com
About this study
Official title: A Randomized, Controlled, Single-center Clinical Study of Lenvatinib in Combination With Tislelizumab With or Without TACE in First-line Treatment of Advanced Hepatocellular Carcinoma.
To explore the effects of lenvatinib in combination with tislelizumab with or without TACE in patients with hepatocellular carcinoma on survival, disease progression, and medication safety.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Lenvatinib Plus Tislelizumab, Transarterial Chemoembolization(TACE)
- Keywords
- Hepatocellular Carcinoma, Lenvatinib, Tislelizumab, Transcatheter arterial chemoembolization, Efficacy, Safety
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenvatinib Plus TislelizumabDrug
Lenvatinib is 12mg/d for body weight >= 60kg, 8mg/d for body weight <60kg, once daily orally, once a day, after meals (take at the same time every day as much as possible); Tislelizumab is administered intravenously at a dose of 200mg/q3w.
Transarterial Chemoembolization(TACE)Device
A catheter is inserted through a small incision in the groin and guided to the hepatic artery, which supplies blood to the liver;A contrast dye is injected through the catheter to help visualize the blood vessels in the liver; A mixture of chemotherapy drugs and an embolic agent (such as small beads or gel foam) is injected through the catheter and into the artery that feeds the tumor;The embolic agent helps to block the blood flow to the tumor, which starves it of oxygen and nutrients; The chemotherapy drugs are then trapped in the tumor.
| Study group | Role | What they receive |
|---|---|---|
| Levatinib plus Tislelizumab | Experimental | Native-treated aHCC Patients were administered with Levatinib plus Tislelizumab Receives: Drug: Lenvatinib Plus Tislelizumab |
| Levatinib plus Lenvatinib with Transarterial Chemoembolization(TACE) | Experimental | Native-treated aHCC Patients were administered with Levatinib plus Tislelizumab with Transarterial Chemoembolization(TACE) Receives: Drug: Lenvatinib Plus Tislelizumab; Device: Transarterial Chemoembolization(TACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
The proportion of patients in a clinical trial who experience either a complete response (CR), a partial response (PR) as a result of treatment.
Measured: baseline up to approximately 6 months
Secondary outcomes (7)
Disease control rate(DCR)
The proportion of patients in a clinical trial who experience either a complete response (CR), a partial response (PR), or stable disease (SD) as a result of treatment.
Measured: baseline up to approximately 6 months
Progression free survival (PFS)
The length of time that a patient survives without their disease progressing.
Measured: baseline up to approximately 12 months
Overall response (OS)
The length of time that a patient survives from the start of treatment until death from any cause.
Measured: baseline up to approximately 12 months
Duration of Overall Response (DOR)
The length of time that a patient experiences a complete or partial response to treatment.
Measured: baseline up to approximately 6 months
3-month/6-month PFS rate
The proportion of patients who survive without their disease progressing for at least 3/6 months after the start of treatment.
Measured: At the time of 3-month/6-month
6-month/12-month OS rate
The proportion of patients who survive for at least 6/12 months after the start of treatment.
Measured: At the time of 6-month/12-month
Conversion surgery rate
The proportion of the patients who recieved the conversion surgery.
Measured: baseline up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Sep 2022
- Primary completion15 Apr 2024 (estimated)
- Study completion15 Nov 2024 (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.
- More trials run by Peking Union Medical College HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842317
- Sponsor's protocol ID
- BGB-HCC-001
- Status last verified
- Feb 2024
- First submitted
- 1 Mar 2023
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Single-center Clinical Study of Lenvatinib in Combination With Tislelizumab With or Without TACE in First-line Treatment of Advanced Hepatocellular Carcinoma.
- ClinicalTrials.gov ID
- NCT05842317
- Acronym / sponsor ID
- BGB-HCC-001
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Lenvatinib, Tislelizumab, Transcatheter arterial chemoembolization, Efficacy, Safety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 15 Apr 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 6 May 2023 (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.
To explore the effects of lenvatinib in combination with tislelizumab with or without TACE in patients with hepatocellular carcinoma on survival, disease progression, and medication safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levatinib plus Tislelizumab | Experimental | Drug: Lenvatinib Plus TislelizumabNative-treated aHCC Patients were administered with Levatinib plus Tislelizumab |
| Levatinib plus Lenvatinib with Transarterial Chemoembolization(TACE) | Experimental | Drug: Lenvatinib Plus Tislelizumab, Device: Transarterial Chemoembolization(TACE)Native-treated aHCC Patients were administered with Levatinib plus Tislelizumab with Transarterial Chemoembolization(TACE) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Participants must meet all of the following criteria to be included:
- Participants must voluntarily agree to participate in the study and provide written informed consent, be compliant, and agree to follow-up.
- Participants must be between 18 and 80 years old, regardless of gender, at the time of signing the informed consent form.
- Participants must be diagnosed with hepatocellular carcinoma by imaging (according to AASLD criteria or the 2022 National Health Commission Guidelines for the Diagnosis and Treatment of Liver Cancer) or histological or cytological examination.
- Patients with advanced liver cancer: patients who are in BCLC stage C or B and are eligible for TACE treatment.
Key exclusion criteria (17 listed)
- Patients with hepatocellular carcinoma who have one or more of the following:
- Suitable for surgical treatment;
- Already underwent radical surgery with no assessable lesions;
- A history of liver transplantation or are preparing for liver transplantation.
- ECOG score ≥ 2 points.
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 |
|---|---|---|
| Lenvatinib Plus TislelizumabLenvatinib is 12mg/d for body weight >= 60kg, 8mg/d for body weight <60kg, once daily orally, once a day, after meals (take at the same time every day as much as possible); Tislelizumab is administered intravenously at a dose of 200mg/q3w. | Drug | Levatinib plus Lenvatinib with Transarterial Chemoembolization(TACE), Levatinib plus Tislelizumab |
| Transarterial Chemoembolization(TACE)A catheter is inserted through a small incision in the groin and guided to the hepatic artery, which supplies blood to the liver;A contrast dye is injected through the catheter to help visualize the blood vessels in the liver; A mixture of chemotherapy drugs and an embolic agent (such as small beads or gel foam) is injected through the catheter and into the artery that feeds the tumor;The embolic agent helps to block the blood flow to the tumor, which starves it of oxygen and nutrients; The chemotherapy drugs are then trapped in the tumor. | Device | Levatinib plus Lenvatinib with Transarterial Chemoembolization(TACE) |
Primary outcome
Overall response rate (ORR)
Time frame: baseline up to approximately 6 months
The proportion of patients in a clinical trial who experience either a complete response (CR), a partial response (PR) as a result of treatment.
7 secondary outcomes
Disease control rate(DCR)
Time frame: baseline up to approximately 6 months
Progression free survival (PFS)
Time frame: baseline up to approximately 12 months
Overall response (OS)
Time frame: baseline up to approximately 12 months
Duration of Overall Response (DOR)
Time frame: baseline up to approximately 6 months
3-month/6-month PFS rate
Time frame: At the time of 3-month/6-month
6-month/12-month OS rate
Time frame: At the time of 6-month/12-month
Conversion surgery rate
Time frame: baseline up to approximately 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lenvatinib Plus Tislelizumab and Transarterial Chemoembolization(TACE) in people with Hepatocellular Carcinoma, run by Peking Union Medical College 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 19 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 9 Feb 2024. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nan Zhang, M.D. (+86 15600802833, zhnan123@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: baseline up to approximately 6 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 9 Feb 2024.