Phase 2 N=10 Randomized Triple-blind Treatment

The Effect of Sorafenib on Portal Pressure

Clinically Significant Portal Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01714609 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

Dec 2015

Primary outcome: Primary: Patients With Change in HVPG From Baseline — 1; 1 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo (Drug); Sorafenib (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Sep 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Patients With Change in HVPG From Baseline	1; 1	—

Summary

Sorafenib is approved by the US FDA for the treatment of unresectable (can not operate) liver cancer and for renal cell carcinoma. Sorafenib is a drug that inhibits the growth of cancer cells and prevents the formation of new blood vessels that would otherwise help the cancer spread. Studies in experimental animals have shown that sorafenib may also lower portal vein pressure (the pressure of the blood passing from the intestine through the liver.) This study seeks to determine if sorafenib lowers the blood pressure in liver blood vessels (portal vein pressure) in patients with cirrhosis who have high portal vein pressure. The study will also obtain information whether sorafenib is safe in this patient population. Half of the patients will be given sorafenib and half will be given a placebo (a pill without any medicine in it.) This allows a comparison of the reactions of people who take sorafenib to those who do not.

Eligibility Criteria

Age 20-75 years
Cirrhosis diagnosed by liver biopsy or by imaging studies showing a nodular liver, splenomegaly and/or collaterals
HCC proven histologically or diagnosed following the AASLD criteria if biopsy not feasible or refused by the patient
HCC must be unresectable and within UCSF criteria (single tumor ≤ 6.5 cm diameter, or, if multiple lesions, maximum diameter of the largest lesion ≤ 4.5 and total tumor diameter ≤ 8 cm (23))
CPT score 5 mmHg
EGD for variceal screening performed within 6 months of entry into the study unless the patient is already on a stable dose of a non selective beta-blocker (adjusted to obtain a heart rate of 55-60 bpm) or treated with variceal band ligation.
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib.
Signed informed consent

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Data sourced from ClinicalTrials.gov (NCT01714609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.