CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Nivolumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03439891
NCT03439891Phase 2Completed

Multicenter Pilot Study of the Safety, Efficacy, and Immune Cell Profiling in Advanced Hepatocellular Carcinoma (HCC) Patients Treated With the Combination of Sorafenib Plus Nivolumab as First-Line of Systemic Therapy

Robin Kate Kelley·interventional·Posted Feb 20, 2018·Updated Feb 11, 2025

In Brief

A Phase 2 clinical trial evaluating Nivolumab and Sorafenib for Stage III Hepatocellular Carcinoma AJCC v8 and 6 related conditions. Completed, enrolled 16 participants across 2 sites.

Detailed Summary

This phase II trial studies the best dose and side effects of sorafenib tosylate and nivolumab in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to nearby tissues or lymph nodes (locally advanced) or to other places in the body (metastatic). Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving sorafenib tosylate and nivolumab may work better in treating patients with liver cancer.

Study Details

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedFeb 20, 2018
Enrollment StartApr 16, 2018
Primary CompletionNov 30, 2023
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 8.4 years ago

Interventions

Nivolumabbiological

Given IV

Sorafenibdrug

Given PO