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TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma (Prolong)

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ClinicalTrials.gov Identifier: NCT04560751
Recruitment Status : Not yet recruiting
First Posted : September 23, 2020
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
guoliang shao, Zhejiang Cancer Hospital

Study Description
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Brief Summary:
This is a multicenter, prospective, observational study in which subjects will be treated with lenvatinib combined with TACE in un-resectable HCC patients who had not received systematic treatment or TACE treatment in the past.

Condition or disease Intervention/treatment
Carcinoma, Hepatocellular Drug: Lenvatinib Procedure: TACE

Detailed Description:
Only 30% of HCC patients received radical resection. Most of the patients are in the advanced stage and can only receive palliative treatment such as TACE or systemic treatment. Lenvatinib is a multi-target receptor tyrosine kinase inhibitor (TKI), which mainly inhibits vascular endothelial growth factor(VEGF) receptor-1, 2, 3; fibroblast growth factors(FGF) receptor-1, 2, 3, 4; platelet derived growth factor receptor(PDGFR)α; RET and KIT and showed significant anti-tumor effect in REFLECT study. The purpose of this study is to explore the efficacy and safety of Lenvatinib and TACE in unresectable HCC patients.
Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma：A Multicenter, Single-armed, Prospective, Observational Study (Prolong)
Estimated Study Start Date : September 30, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Lenvatinib

Groups and Cohorts
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Group/Cohort Intervention/treatment
Lenvatinib and TACE
Patients in Lenvatinib + TACE group will take oral lenvatinib within ten days after TACE.
 Drug: Lenvatinib
Lenvatinib capsules will be administered orally, once daily (for patients <60kg, lenvatinib 8mg po; for patients ≥60kg, lenvatinib 12mg po)

Procedure: TACE
TACE will be performed as needed.


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate（ORR） [ Time Frame: up to 12 months ]
    The percentage of patients who have best overall response of complete response (CR) or partial response (PR) according to mRECIST.


Secondary Outcome Measures :
  1. Intrahepatic ORR and Extrahepatic ORR [ Time Frame: up to 12 months ]
    The percentage of patients who have best overall response of complete response (CR) or partial response (PR) according to mRECIST intrahepatic or extrahepatic, respectively.

  2. Progression-free survival (PFS) [ Time Frame: up to 12 months ]
    The time from the beginning of treatment of TACE to the time of tumor progression or death from any cause (according to mRECIST standard)

  3. Alpha-fetoprotein (AFP) response rate [ Time Frame: up to 12 months ]
    A decrease in AFP of more than 20% in AFP+ patients treated with lenvatinib is defined as an AFP response.AFP response rate defined as the percentage of AFP response patients in all AFP positive patients.

  4. Time to progression（TTP） [ Time Frame: up to 12 months ]
    The time from the beginning of treatment of TACE to the time of tumor progression. (according to mRECIST standard)

  5. Adverse events(AEs) [ Time Frame: up to 18 months ]
    AEs(adverse events) evaluated by the CTC-AE 5.0


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Unrecestable CNLC stage IIb-IIIb HCC patients
Criteria

Inclusion Criteria:

  1. Ages of ≥ 18 and ≤ 75 years old.
  2. Clinically or histopathologically diagnosed as hepatocellular carcinoma (HCC).
  3. China stage IIb-IIIb patients, not suitable for surgical resection.
  4. The imaging examination within 2 weeks before interventional therapy showed that there was at least one target lesion that could be measured by CT or MRI, and the lesion was suitable for repeated and accurate measurement.
  5. Child-Pugh scores ≤7.
  6. ECOG：0-1.
  7. Intended to be treated with TACE combined with lenvatinib.
  8. Good organ and bone marrow function: Blood routine: WBC>4.0×109/L、Hb>80g/L, PLT>75×109/L, NEUT>1.5×10⁹/L. Blood coagulation function: International normalized ratio (INR)<1.2. Hepatic function: serum albumin (ALB)>3.5 g/dl, total bilirubin (TBIL) <1.5 × normal upper limit (ULN) (Eliminate biliary obstruction), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 3 × ULN. Renal dysfunction：serum creatinine (SCR) <1.5× ULN.
  9. Agreed to join the clinical trial and sign the informed consent form.

Exclusion Criteria:

  1. Hepatobiliary cell carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma.
  2. With invasion of the main portal vein or vena cava.
  3. Received interventional therapy such as TACE within 2 years.
  4. Received systematic treatment in the past.
  5. Uncontrollable ascites, hepatic encephalopathy or esophagogastric variceal bleeding.
  6. Patients with hypertension who cannot be reduced to normal range after antihypertensive treatment (systolic blood pressure > 140mmHg, or diastolic blood pressure > 90 mmHg).
  7. Suffering from grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia or myocardial ischemia or myocardial infarction (The QTc interval ≥ 450ms, QTc interval is calculated by Fridericia formula).
  8. There is a history of gastrointestinal bleeding or a clear tendency of gastrointestinal bleeding in the past 3 months, such as esophageal varices at risk of bleeding, local active ulcer lesions, fecal occult blood ≥ (+).
  9. Pregnant or lactating women. A fertile patient who is unwilling or unable to use effective contraception.
  10. Patients with HIV infection.
  11. Suspected allergy to research drugs.
  12. Other situations which the researchers considered ineligible for participating in the trial.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04560751


Contacts
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Contact: Guoliang Shao, Professor 13989898089 zenghuiray@163.com

Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
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Study Chair: Guoliang Shao, Professor Zhejiang Cancer Hospital
More Information
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Responsible Party: guoliang shao, Vice President of Zhejiang Cancer Hospital, Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT04560751    
Other Study ID Numbers: Prolong
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by guoliang shao, Zhejiang Cancer Hospital:
Transarterial chemoembolization
Lenvatinib
Carcinoma, Hepatocellular
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Liver Diseases
Lenvatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action