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Hepatocellular CarcinomaPhase 3NCT05056337

Toripalimab in Combination With Lenvatinib and TACE for Conversion Therapy in Patients With Potentially Resectable HCC

A Phase 3 study testing Lenvatinib 4 MG Oral Capsule [Lenvima], Toripalimab and TACE in people with Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Study introduction: this is a multicenter, randomized controlled study of patients with histopathologically confirmed hepatocellular carcinoma (HCC) who have not previously received systematic treatment for HCC, all the patients are Chinese stage IIb/IIIa (BCLC stage B/C), and have not developed extrahepatic… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Lenvatinib 4 MG Oral Capsule [Lenvima], Toripalimab and TACE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
1 siteChina
Study dates
1 Aug 2021to 1 Dec 2023
Phase
Phase 3
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients of 18-75 years old;
  • Clinical or histopathological diagnosis of hepatocellular carcinoma;
  • ECOG PS score of 0-1, Child-Pugh grade A;
  • Chinese stage IIb/IIIa (equal to BCLC B/C) patients with portal vein tumor thrombus (according to the Japanese PVTT grading criteria Vp3-Vp4) or more than 3 tumor nodules, without extrahepatic metastasis;
  • According to the evaluation by the site multi-disciplinary team (MDT), surgical resection is not the current preferred treatment;
  • No previous systemic treatment for hepatocellular carcinoma; no previous use of PD-1 inhibitor, PD-L1 inhibitor, lenvatinib or sorafenib;
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  • Previous TACE treatment for 0-2 times
  • The patients in the treatment group voluntarily and have decided to receive treatment of lenvatinib in combination with toripalimab and TACE, and sign an informed consent form. Additional identification of qualified subjects: subjects who have received at least one combination medication enter the safety evaluation; subjects who have received at least one imaging evaluation after treatment enter the efficacy evaluation. The patients in the control group treated with TACE alone have at least one imaging evaluation.
  • Patients with HBV infection (characterized by hepatitis B surface antigen [HBsAg] positive and/or hepatitis B core antibody [anti-HBcAb], with detectable HBV DNA [>10 IU/mL]) should be treated with antiviral therapy according to clinical routine, so as to ensure adequate viral suppression (HBV DNA≤2000 IU/mL or 104) before enrollment. Patients must maintain antiviral therapy during the study period and within 6 months after the last study drug administration; patients with positive hepatitis B core antibody (HBc) and undetectable HBV DNA (<10 IU/mL) will be not required to receive antiviral therapy before enrollment; these patients will be checked every cycle to monitor HBV DNA levels; if HBV DNA is detected (> 10 IU/mL), antiviral therapy will be initiated; patients with detectable HBV DNA must continue to receive antiviral therapy during the study

Who cannot join

  • Clinical or pathological diagnosis of mixed liver cancer, fibrolamellar hepatocellular carcinoma or other non-hepatocellular malignant tumor components;
  • Hematological examination: PLT<50×109/L, WBC<3.0×109/L or not meet the requirements of TACE treatment;
  • Coagulation function: international normalized (prothrombin time) ratio (INR) > 1.2;
  • Liver function indicators: serum albumin (ALB) < 2.8 g/dl, serum total bilirubin (TBIL) > 1.5 times the upper limit of normal (excluding those with biliary obstruction), serum transaminase (ALT and AST) > 3 times the upper limit of normal;
  • Renal function indicators: serum creatinine (CR) > 1.5 times the upper limit of normal;
  • Uncontrollable hypertension (defined as diastolic blood pressure > 90 mmHg or systolic blood pressure > 150 mmHg);
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  • Patients with bile duct tumor thrombi, superior mesenteric vein tumor thrombi and diffuse portal vein tumor thrombi;
  • Participated in other clinical trials 30 days before screening;
  • Accompanied by hepatic encephalopathy, Gilbert syndrome, sclerosing cholangitis, etc.;
  • Acute gastrointestinal bleeding recorded within the last 3 months;
  • Have a history of allogeneic transplantation (such as liver transplantation);
  • Patients with acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV) DNA > 2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA > 103 copies/ml; those who are positive for both hepatitis B surface antigen (HbsAg) and anti-HCV antibodies.
  • Patients who have autoimmune diseases or a history of autoimmune diseases or syndromes requiring systemic use of steroids / immunosuppressants, including hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism etc.
  • Be suspected of being allergic to study drugs;
  • Patients with other organ dysfunction who are expected to be unable to tolerate general anesthesia or hepatectomy;
  • Other conditions in which the investigators deem the patients unsuitable for the clinical trial

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200000

Other trials in China

About this study

Official title: Efficacy and Safety of Toripalimab in Combination With Lenvatinib and TACE for Conversion Therapy in Patients With Potentially Resectable Hepatocellular Carcinoma: a Prospective, Multicenter, Randomized Controlled Study

Study introduction: this is a multicenter, randomized controlled study of patients with histopathologically confirmed hepatocellular carcinoma (HCC) who have not previously received systematic treatment for HCC, all the patients are Chinese stage IIb/IIIa (BCLC stage B/C), and have not developed extrahepatic metastases. Follow-up, data collection and analysis will be performed for patients who meet the study inclusion criteria and will be treated with lenvatinib plus toripalimab and TACE (on demand) or TACE alone, so as to compare the objective response rate (ORR), overall survival (OS), progression-free survival (PFS), ratio of conversion resection, and safety between the two cohorts.

Read the detailed description

The study includes two groups:

Treatment group: patients with potentially resectable HCC who meet the study inclusion criteria will be treated with lenvatinib in combination with toripalimab and TACE (on demand). Tumor response will be regularly evaluated, data will be collected, and complete surgical resection will be evaluated by an independent review committee, the conversion resection rate will be calculated, and patient survival will be assessed.

Control group: patients with potentially resectable HCC who meet the study inclusion criteria will be treated with TACE. Tumor response will be regularly evaluated, data will be collected, and complete surgical resection will be evaluated by an independent review committee, the translational resection rate will be calculated, and patient survival will be assessed.

The maximum duration of study treatment for each subject is expected to be 48 weeks, with efficacy evaluation by the MDT after 2 TACE treatments to determine whether subjects meet the surgical criteria.

This study is a multicenter, randomized controlled study. The primary endpoint is the objective response rate (ORR). Historical data showed that the objective response rate of patients in the TACE group was about 40%. The objective response rate of lenvatinib in combination with toripalimab and TACE is expected to reach 60%. Using a two-sided Z test of pooled variance, α is set to 0.05, power is set to 0.8, and patients will be assigned at a 1:1 ratio. The required sample sizes are 98 (treatment group) and 98 (control group), and a total of 220 subjects are planned to be prospectively observed, taking into account a dropout rate of 10%.

Being tested
Lenvatinib 4 MG Oral Capsule [Lenvima], Toripalimab, TACE
Keywords
Toripalimab, Lenvatinib, TACE, conversion therapy, HCC
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 4 MG Oral Capsule [Lenvima]Drug

    patients will be treated with lenvatinib in combination with toripalimab and TACE (on demand)

  • ToripalimabDrug

    patients will be treated with lenvatinib in combination with toripalimab and TACE (on demand)

  • TACEProcedure or surgery

    Hepatic arterial chemoembolization

Study groups in NCT05056337
Study groupRoleWhat they receive
Treatment groupExperimentalPatients with potentially resectable HCC who meet the study inclusion criteria will be treated with lenvatinib(8mg/d for BW<60kg and 12mg for BW≥60kg) in combination with toripalimab(240mg iv Q3W) and TACE (on demand). Tumor response will be regularly evaluated, data will be collected, and complete surgical resection will be evaluated by an independent review committee, the conversion resection rate will be calculated, and patient survival will be assessed.
Receives: Drug: Lenvatinib 4 MG Oral Capsule [Lenvima]; Drug: Toripalimab; Procedure: TACE
Control groupActive comparatorPatients with potentially resectable HCC who meet the study inclusion criteria will be treated with TACE alone. Tumor response will be regularly evaluated, data will be collected, and complete surgical resection will be evaluated by an independent review committee, the translational resection rate will be calculated, and patient survival will be assessed.
Receives: Procedure: TACE

What is being measured

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

  1. Tumor response: Objective response rate (assessed based on mRECIST criteria)

    Proportion of patients who achieve pre-defined tumor volume reduction and can maintain the minimum time limit, as the sum of complete response (CR) and partial response (PR) ratios (assessed based on mRECIST criteria)

    Measured: Up to approximately 36 months

Secondary outcomes (5)

  1. Tumor response: Objective response rate (assessed based on RECIST1.1 criteria)

    Proportion of patients who achieve pre-defined tumor volume reduction and can maintain the minimum time limit, as the sum of complete response (CR) and partial response (PR) ratios (assessed based on RECIST1.1 criteria)

    Measured: Up to approximately 36 months

  2. Overall survival (OS)

    Time period from the patient's enrollment to death due to any cause.

    Measured: Up to approximately 36 months

  3. Progression-free survival (PFS)

    Time period from the patient's enrollment to the event of tumor progression or death.

    Measured: Up to approximately 36 months

  4. Percentage of patients who can receive resection.

    Percentage of patients who can receive resection.

    Measured: Up to approximately 36 months

  5. Adverse Events as assessed by CTCAE 5.0 criteria

    the main evaluation includes surgery-related adverse events, adverse events (AE), Serious adverse events (SAE), vital signs, physical examination, and laboratory examination. The severity of adverse events will be evaluated according to the NCI CTCAE 5.0 criteria.

    Measured: Up to approximately 36 months

Timeline

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

  1. First posted24 Sep 2021
  2. Study start1 Aug 2021
  3. Primary completion1 Nov 2023 (estimated)
  4. Study completion1 Dec 2023 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05056337
Sponsor's protocol ID
B2021-338(2)
Status last verified
Sep 2021
First submitted
17 Aug 2021
Last updated
24 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenvatinib 4 MG Oral Capsule [Lenvima], Toripalimab and TACE in people with Hepatocellular Carcinoma, run by Shanghai Zhongshan 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 9 inclusion and 16 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 24 Sep 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Tumor response: Objective response rate (assessed based on mRECIST criteria) (time frame: Up to approximately 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 NCT05056337.

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 24 Sep 2021.

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