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PD-1 Monoclonal Antibody, Lenvatinib and TACE in the Treatment of HCC

NCT04273100 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2020-02-17

No results posted yet for this study

Summary

The vast majority of primary liver cancer (90%) is hepatocellular carcinoma (HCC), and the majority of HCC patients have been locally advanced or metastatic disease when they are diagnosed in clinics. Most of them are not suitable for radical treatment. In the case of supportive treatment, the median survival time was only 7.9 months. Therefore, there is an urgent need for effective treatment for these patients.

At present, the overall objective response rate (ORR) of single or sequential therapy is not satisfied, and the over survival (OS) improvement is not ideal. Therefore, combined therapy maybe the good choice for patients with advanced HCC.

This study focuses on the in-operable, middle and late stage (BCLC-B and BCLC-C) HCC patients. Through the combination of immunotherapy (PD-1 monoclonal antibody), local therapy (TACE) and anti-angiogenic therapy (lenvatinib), it is expected to change the tumor microenvironment, restore the immune response, strengthen the anti-tumor effect of various treatments, and improve the therapeutic efficacy in patients with middle and late stage HCC.

Conditions

  • Hepatocellular Carcinoma Non-resectable

Interventions

COMBINATION_PRODUCT

PD-1 mAb combined with TACE and lenvatinib

the combination of immunotherapy (PD-1 monoclonal antibody), local therapy (TACE) and anti-angiogenic therapy (lenvatinib)

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-14
Primary Completion
2020-12-31
Completion
2021-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04273100 on ClinicalTrials.gov