NCT01425996

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2011

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 30, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 27, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2014

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

2.9 years

First QC Date

August 15, 2011

Last Update Submit

August 20, 2018

Conditions

Carcinoma, Hepatocellular

Keywords

HCCPVTT

Outcome Measures

Primary Outcomes (4)

  • Maximum tolerated dose (MTD)

    Maximum tolerated dose

    week 12

  • PVTT response rate

    PVTT response rate

    week7

  • Dose-limiting toxicity (DLT)

    Dose-limiting toxicity

    week 12

  • Adverse Event/Serious Adverse Event

    Serious/ Adverse Event

    week 12

Secondary Outcomes (6)

  • Hepatic tumor response rate (overall tumor response rate)

    week7, week12

  • Tumor downstaging rate

    week7, week12

  • Time to progression (TTP)

    week7, week12, 1 year

  • Progression-free survival (PFS)

    week7, week12, 1 year

  • Overall survival (OS)

    week7, week12, 1year

  • +1 more secondary outcomes

Study Arms (1)

Lipotecan® (TLC388)

EXPERIMENTAL

Dosage form: 40mg TLC388 base/vial lyophilized cake Dose: Chemotherapy, i.v. q.w. x 6 doses (dose-escalation) \* The dosage regimen would be escalated gradually until MTD had been found out.

Drug: Lipotecan® (TLC388)

Interventions

Lipotecan® (TLC388)DRUG

* 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

Also known as: Lipotecan (TLC388)
Lipotecan® (TLC388)

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females or males 20-70 years of age (inclusive)
  • Patients with histological confirmed HCC or other conditions
  • Patients with locally advanced HCC and PVTT that is not suitable for other local therapies

You may not qualify if:

  • Females who are pregnant/lactating or planning to be pregnant, or patients of childbearing potential who are not using medically recognized method of contraception.
  • Patients with documented extrahepatic metastasis
  • Patients with stage III-IV encephalopathy or tense ascites
  • Patients who have received any local or systemic therapy for HCC within 4 weeks prior to the initiation of study treatment
  • Patients who have received Lipotecan® treatment prior to the initiation of study treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mackay Memorial Hospital

Taipei, Taiwan

Location

Taipei Veteran General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

TLC 388

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Tsang-En Wa, MD

    Mackay Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Yee Chao, MD

    Taipei Veteran General Hospital

    PRINCIPAL INVESTIGATOR

  • Chen-Hsi Hsieh, MD

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Jacqueline Whang-Peng, MD

    Wan Fang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2011

First Posted

August 30, 2011

Study Start

October 27, 2011

Primary Completion

October 3, 2014

Study Completion

October 3, 2014

Last Updated

August 21, 2018

Record last verified: 2018-08

Locations

TW(2)