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Phase II of Lenvatinib Plus Toripalimab for Advanced HCC

  • identifier


  • Recruitment Status

    Withdrawn (No participants enrolled)

  • First Posted

    April 18, 2019

  • Last update posted

    June 3, 2019

Study Description

Brief summary:

The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with toripalimab in patients with advanced hepatocellular carcinoma (HCC)

  • Condition or Disease:Hepatocellular Carcinoma
  • Intervention/Treatment: Drug: Lenvatinib
    Drug: Toripalimab
  • Phase: Phase 2

Detailed Description

Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. No study has evaluated the efficacy and safety of lenvatinib plus toripalimab. Thus, the investigators carried out this single-arm, prospective, phase II study to find out it.

Study Design

  • Study Type: Interventional
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Phase II of Lenvatinib Plus Toripalimab Advanced Hepatocellular Carcinoma: a Single-arm Prospective Trial
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: December 2019
  • Estimated Study Completion Date: December 2019

Arms and interventions

Arm Intervention/treatment
Experimental: Lenvatinib Plus Toripalimab
Participants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (<) 60 kg at baseline, orally, once daily (QD) in continuous 21-day treatment cycles, and received 240mg toripalimab intravenously every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Drug: Lenvatinib
12 mg (or 8 mg) once daily (QD) oral dosing

Drug: Toripalimab
240mg intravenously every 3 weeks

Outcome Measures

  • Primary Outcome Measures: 1. 6 months progression free survival rates [ Time Frame: 6 months ]
    Progression was defined as progressive disease by independent radiologic review according to RECIST, version 1.1, criteria or death from any cause.
  • Secondary Outcome Measures: 1. Progression Free Survival (PFS) [ Time Frame: 6 months ]
    PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST), or date of death, whichever occurred first.
  • 2. Overall Survival (OS) [ Time Frame: 6 months ]
    OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
  • 3. Objective Response Rate (ORR) [ Time Frame: 6 months ]
    ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on RECIST. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference to the baseline sum of the diameters of target lesions
  • 4. Adverse Events [ Time Frame: 6 months ]
    Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03

Eligibility Criteria

  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No


Inclusion Criteria:

- The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European
Association for the Study of the Liver (EASL)

- Patients must have at least one tumor lesion that can be accurately measured according
to EASL criteria.

- Barcelona clinic liver cancer-stage C

- Eastern Cooperative Oncology Group performance status of 0 to 2

- with no previous systemic treatment

- No Cirrhosis or cirrhotic status of Child-Pugh class A only

- Not amendable to surgical resection ,local ablative therapy and any other cured

- The following laboratory parameters:

Platelet count ≥ 75,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥
30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of
normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
Ability to understand the protocol and to agree to and sign a written informed consent

Exclusion Criteria:

- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or
hepatic encephalopathy

- Known history of HIV

- History of organ allograft

- Known or suspected allergy to the investigational agents or any agent given in
association with this trial.

- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

- Evidence of bleeding diathesis.

- Patients with clinically significant gastrointestinal bleeding within 30 days prior to
study entry.

- Known central nervous system tumors including metastatic brain disease

Contacts and Locations



China, Guangdong
Cancer Center Sun Yat-sen University

Sponsors and Collaborators

Sun Yat-sen University

More Information

  • Responsible Party: Sun Yat-sen University
  • Identifier: NCT03919383 History of Changes
  • Other Study ID Numbers: hcc-S052b
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: June 3, 2019
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Sun Yat-sen University: Hepatocellular Carcinoma
  • Additional relevant MeSH terms: Carcinoma, Hepatocellular Carcinoma