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

Sponsor
Taiwan Liposome Company (Industry)
Overall Status
Terminated
CT.gov ID
NCT01425996
Collaborator
(none)
3
Enrollment
2
Locations
1
Arm
35.2
Actual Duration (Months)
1.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lipotecan® (TLC388)
 Phase 1/Phase 2

Detailed Description

Lipotecan® is a drug product of TLC388 HCl, which is a potent camptothecin analog with cytotoxic activities against a variety of human tumor cell lines and anti-tumor activities in several xenograft models with human tumor cell lines. Structurally, TLC388 HCl is related to other camptothecins, but it has been chemically modified to improve stability and potency, and to minimize toxicities.

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I/II, Dose-escalation Study of Lipotecan® Plus Radiotherapy in Locally Advanced Hepatocellular Carcinoma
Actual Study Start Date :
Oct 27, 2011
Actual Primary Completion Date :
Oct 3, 2014
Actual Study Completion Date :
Oct 3, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lipotecan® (TLC388)

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)
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
Other Names:
  • Lipotecan (TLC388)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum tolerated dose (MTD) [week 12]

      Maximum tolerated dose

    2. PVTT response rate [week7]

      PVTT response rate

    3. Dose-limiting toxicity (DLT) [week 12]

      Dose-limiting toxicity

    4. Adverse Event/Serious Adverse Event [week 12]

      Serious/ Adverse Event

    Secondary Outcome Measures

    1. Hepatic tumor response rate (overall tumor response rate) [week7, week12]

      Hepatic tumor response rate (overall tumor response rate)

    2. Tumor downstaging rate [week7, week12]

      Tumor downstaging rate

    3. Time to progression (TTP) [week7, week12, 1 year]

      Time to progression

    4. Progression-free survival (PFS) [week7, week12, 1 year]

      Progression-free survial

    5. Overall survival (OS) [week7, week12, 1year]

      Overall survival

    6. Change from baseline in tumor marker/biomarkers [week4, week7, week12]

      Change from baseline in tumor marker/biomarkers

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    • Other inclusion criteria also apply

    Exclusion Criteria:

    • 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

    • Other exclusion criteria also apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mackay Memorial Hospital Taipei Taiwan
    2 Taipei Veteran General Hospital Taipei Taiwan

    Sponsors and Collaborators

    • Taiwan Liposome Company

    Investigators

    • Principal Investigator: 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Taiwan Liposome Company
    ClinicalTrials.gov Identifier:
    NCT01425996
    Other Study ID Numbers:
    • TLC388.2
    First Posted:
    Aug 30, 2011
    Last Update Posted:
    Aug 21, 2018
    Last Verified:
    Aug 1, 2018
    Keywords provided by Taiwan Liposome Company
    HCC
    PVTT
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Camptothecin

    Study Results

    No Results Posted as of Aug 21, 2018