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

NCT04518852 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-06-25

No results posted yet for this study

Summary

Hepatocellular carcinoma (HCC) is the fourth most common cause of cancer-related death that ranks sixth in terms of incident cases, with an overall 5 years survival of 18%. Despite a significant improvement in treatment strategy, the overall survival of HCC remains low due to high recurrence, progressive liver dysfunction and the high fatality of the disease. Surgical resection has been applied in a number of patients; however, surgery has been associated with a high incidence of recurrence (approximately 70% within 5 years). TACE is generally applied on intermediate-stage HCC. However, TACE is not satisfied with improving overall survival. 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, BCLC-B/C HCC patients. Through the combination of local therapy (TACE), anti-angiogenic therapy (Sorafenib), and immunotherapy (PD-1 monoclonal antibody), 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 BCLC-B/C HCC.

Conditions

Interventions

COMBINATION_PRODUCT

TACE combined with sorafenib and PD-1 mAb

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

Sponsors & Collaborators

  • Sichuan Cancer Hospital and Research Institute

    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
2020-09-14
Primary Completion
2022-07-31
Completion
2023-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT04518852 on ClinicalTrials.gov