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A Phase I, Open-label Study to Assess the Safety and Efficacy of Poly-ICLC Plus Nivolumab in Unresectable Hepatocellular Carcinoma Patients

NCT05281926 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-03-16

No results posted yet for this study

Summary

Hepatocellular carcinoma (HCC) is a prevalent malignancy with great disease burden both in Taiwan and worldwide 1. Early stage HCC can be treated by surgical resection, radiofrequency ablation, embolization and liver transplantation. However, treatments for advanced HCC are still unsatisfactory. Systemic therapy is necessary for advanced HCC 2. Target therapy using sorafenib was established a decade ago, but its response rate is quite low (\~3%), the adverse effects may be intolerable and it can only extend survival 2.3 to 2.8 months 3,4. Newly developed tyrosine kinase inhibitors (TKIs) include regorafenib 5, lenvatinib 6, cabozantinib 7 and ramucirumab 8. The single target therapy objective response rate is around 3-24%. Recently, immune checkpoint inhibitors (ICIs) emerged as a new hope for cancer therapy in various kinds of malignancies including HCC. These include CTLA4, PD-1 and PD-L1 blockades.

Conditions

Interventions

DRUG

Poly ICLC

IT Poly-ICLC injection (1.0 mg) at Day 1 of weeks 0, 1 and 2. IM Poly-ICLC (20 μg/Kg) at Day 1 and Day 3 of weeks 3, 4, 5 and 6.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2024-06-30
Completion
2024-09-30

Countries

  • Taiwan

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 NCT05281926 on ClinicalTrials.gov