CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
bevacizumabbiological
Likely dose
Bevacizumab 10 mg/kg intravenously every two weeks, starting 1 week prior to first chemoembolizationAI-extracted
Key inclusion· 6
  • Age >18 years
  • Histologically or cytologically confirmed hepatocellular carcinoma
  • Bidimensional measurable disease on CT or MRI not exceeding 50% of liver parenchyma
  • Clinical candidate for chemoembolization with at least one lesion >3 cm and no lesion >15 cm in longest diameter
Key exclusion· 11
  • Previous liver transplantation
  • Fibrolamellar histology
  • Prior antiangiogenesis therapy
  • Extrahepatic disease present

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

Search/NCT00049322
NCT00049322Phase 2Completed

A Phase II Study Of rhuMAb VEGF (BEVACIZUMAB) In Patients With Hepatocellular Carcinoma Receiving Chemoembolization

Jonsson Comprehensive Cancer Center·interventional·Posted Jan 27, 2003·Updated Sep 1, 2020

In Brief

A Phase 2 clinical trial evaluating bevacizumab for Liver Cancer. Completed, enrolled 30 participants across 1 site.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, cisplatin, and mitomycin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping the cells from dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Monoclonal antibodies, such as bevacizumab, can kill any tumor cells that are left after chemoembolization by blocking their ability to grow and spread. PURPOSE: This randomized phase II trial is studying to see if chemoembolization followed by bevacizumab works better than chemoembolization alone in treating patients who have liver cancer that cannot be removed with surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartJun 1, 2003
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 23.4 years ago

Interventions

bevacizumabbiological

Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization. Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose.