TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma (Prolong)

NCT04560751 | Unknown

• 1 other identifier: Prolong
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carcinoma, Hepatocellular

Keywords

Transarterial chemoembolization; Lenvatinib; Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• Objective response rate（ORR）

  The percentage of patients who have best overall response of complete response (CR) or partial response (PR) according to mRECIST.

  up to 12 months

Secondary Outcomes (5)

• Intrahepatic ORR and Extrahepatic ORR

  up to 12 months

• Progression-free survival (PFS)

  up to 12 months

• Alpha-fetoprotein (AFP) response rate

  up to 12 months

• Time to progression（TTP）

  up to 12 months

• Adverse events(AEs)

  up to 18 months

Study Arms (1)

Lenvatinib and TACE

Patients in Lenvatinib + TACE group will take oral lenvatinib within ten days after TACE.

Drug: Lenvatinib; Procedure: TACE

Interventions

Lenvatinib DRUG

Lenvatinib capsules will be administered orally, once daily (for patients \<60kg, lenvatinib 8mg po; for patients ≥60kg, lenvatinib 12mg po)

Lenvatinib and TACE

TACE PROCEDURE

TACE will be performed as needed.

Lenvatinib and TACE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Unrecestable CNLC stage IIb-IIIb HCC patients

You may qualify if:

• Ages of ≥ 18 and ≤ 75 years old.
• Clinically or histopathologically diagnosed as hepatocellular carcinoma (HCC).
• China stage IIb-IIIb patients, not suitable for surgical resection.
• 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.
• Child-Pugh scores ≤7.
• ECOG：0-1.
• Intended to be treated with TACE combined with lenvatinib.
• 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.
• Agreed to join the clinical trial and sign the informed consent form.

You may not qualify if:

• Hepatobiliary cell carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma.
• With invasion of the main portal vein or vena cava.
• Received interventional therapy such as TACE within 2 years.
• Received systematic treatment in the past.
• Uncontrollable ascites, hepatic encephalopathy or esophagogastric variceal bleeding.
• Patients with hypertension who cannot be reduced to normal range after antihypertensive treatment (systolic blood pressure \> 140mmHg, or diastolic blood pressure \> 90 mmHg).
• 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).
• 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 ≥ (+).
• Pregnant or lactating women. A fertile patient who is unwilling or unable to use effective contraception.
• Patients with HIV infection.
• Suspected allergy to research drugs.
• Other situations which the researchers considered ineligible for participating in the trial.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Guoliang Shao, Professor

  Zhejiang Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Guoliang Shao, Professor

CONTACT

13989898089; zenghuiray@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Zhejiang Cancer Hospital

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 23, 2020
• Study Start: September 30, 2020
• Primary Completion: December 31, 2021
• Study Completion: August 31, 2022
• Last Updated: September 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share