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Two-Drug cocktail shows promise against tough liver cancer

NCT ID NCT03211416

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a combination of two drugs—sorafenib (a targeted therapy) and pembrolizumab (an immunotherapy)—in 37 people with advanced liver cancer that had spread. The goal was to see if the combo could shrink tumors and help people live longer. The trial was early-stage, so results are promising but not yet proven for widespread use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sorafenib and pembrolizumab (a targeted therapy and an immunotherapy drug combination)
What this could lead to
If it works, this combination could offer a new treatment option for advanced liver cancer, potentially shrinking tumors and extending survival.
What could go wrong
This was a small, early-phase trial (37 people), so results may not apply to everyone. Side effects from the drug combination can be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

37 people

The number who actually took part.

Started

Dec 2017

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant must have histologically or radiographically confirmed hepatocellular cancer (HCC) that is advanced or metastatic and if archival tissue is available, have archival tissue submitted for PD-L1, PD-L2 testing * Participants with measurable disease that has progressed are eligible if prior surgery or locoregional therapy occurred \> 28 days prior to enrollment * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Karnofsky \>= 60%) * Child-Pugh class-A liver function * Absolute neutrophil count (ANC) \>= 1,500/ mcL * Hemoglobin \>= 8.5 g/dL * Platelets \>= 75,000/ mcL * Total bilirubin =\< 2.0 mg/dL * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 5 X ULN * Serum Creatinine \<= 1.5 upper limit of normal (ULN)or Creatinine clearance \> 50 mL/minute if serum creatinine is elevated above 1.5 X ULN * Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present * Ability to swallow and retain oral medication * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure * Participants with past or ongoing hepatitis C virus (HCV) infection will be eligible for the study. The treated participants must have completed their treatment at least 1 month prior to starting study intervention. * Participants with controlled hepatitis B will be eligible as long as they meet the following criteria: Antiviral therapy for HBV must be given for at least 12 weeks and HBV viral load must be less than 100 IU/ml prior to first dose of study drug. Participants on active HBV therapy with viral loads under 100 IU/mL should stay on the same therapy throughout study treatment Participants who are anti-HBc , negative for Hepatitis B surface antigen (HBsAg) and negative or positive for anti-HBs, and who have an HBV viral load under 100 IU/mL , do not require HBV anti-viral prophylaxis Exclusion Criteria: * One prior line of therapy that may include a PDL1 blocker allowed, no prior sorafenib or PD1 blocker allowed. * Participants who have had radiotherapy or chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Any evidence of bleeding diathesis (patients on therapeutic warfarin or heparin will be excluded) * Participants with a history of variceal bleed within 6 months prior to enrollment * Known human immunodeficiency virus (HIV)-positive participants (even if on combination retrovirals, participant will be excluded * Participants with chronic autoimmune disease * Participants with known brain metastases should be excluded from this clinical trial * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Has known history of, or any evidence of active, non-infectious pneumonitis * Pregnant or nursing female participants * Unwilling or unable to follow protocol requirements * Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug * Received a live vaccine within 30 days prior to start of study treatment

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Robert H Lurie Comprehensive Cancer Center

    Chicago, Illinois, 60611, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

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