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A Dose-escalation Study of Lipotecan® Plus Radiotherapy in Locally Advanced Hepatocellular Carcinoma

NCT01425996 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2018-08-21

No results posted yet for this study

Summary

Radiotherapy (R/T) for locally advanced hepatocellular carcinoma (HCC) is often used in patient who is not suitable for transarterial chemoembolization (TACE) and other local therapy, especially in those with portal vein tumor thrombosis (PVTT) caused by tumor cells. Several previous studies have showed that local R/T is tolerable and can induce a substantial tumor response in HCC management. In addition, the safety, toxicity and preliminary efficacy of Lipotecan® (TLC388) has also been proved in patients with terminal malignancy. This study aims to evaluate the safety, tolerability and efficacy of concomitant Lipotecan® and radiotherapy in patients with locally advanced HCC and PVTT.

Conditions

  • Carcinoma, Hepatocellular

Interventions

DRUG

Lipotecan® (TLC388)

* Cohort A1: TLC388 15 mg/m2 x 6 dose + 3DCRT * Cohort A2: TLC388 30 mg/m2 x 6 dose + 3DCRT * Cohort A3: TLC388 40 mg/m2 x 6 dose + 3DCRT * Cohort A4: TLC388 50 mg/m2 x 6 dose + 3DCRT (dose-escalation) * Cohort A"x": TLC388 "MTD" x 6 dose + 3DCRT

Sponsors & Collaborators

  • Taiwan Liposome Company

    lead INDUSTRY

Principal Investigators

  • Tsang-En Wa, MD · Mackay Memorial Hospital

  • Yee Chao, MD · Taipei Veteran General Hospital

  • Chen-Hsi Hsieh, MD · Far Eastern Memorial Hospital

  • Jacqueline Whang-Peng, MD · Wan Fang Hospital

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-27
Primary Completion
2014-10-03
Completion
2014-10-03

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01425996 on ClinicalTrials.gov