Pilot Study of Effect of Sorafenib on Portal Pressure

Status: Recruiting
Phase:
Diagnosis: Gastrointestinal Malignancies
NCT ID: NCT01714609 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-491

 

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.

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Amir Qamar, MD, Brigham and Women's Hospital

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Gastrointestinal Research Line, 617-632-5960

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 <9 (that is all Child A and Child B with a score of 7 or 8) - Complete response to treatment with RFA (including that performed laparoscopically) or TACE or a combination of the above as defined by radiologic criteria (hepatoma protocol MRI or CT scan performed 4-6 weeks after the procedure). - No more than two ablative procedures prior to enrollment - Presence of portal hypertension, as defined by HVPG of >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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