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

NCT ID: NCT01425996

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-27
• Study Completion Date: 2014-10-03

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.

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.

Conditions

Carcinoma, Hepatocellular

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lipotecan® (TLC388)

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Lipotecan (TLC388)

Eligibility Criteria

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

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taiwan Liposome Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tsang-En Wa, MD

Role: PRINCIPAL_INVESTIGATOR

Mackay Memorial Hospital

Yee Chao, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veteran General Hospital

Chen-Hsi Hsieh, MD

Role: PRINCIPAL_INVESTIGATOR

Far Eastern Memorial Hospital

Jacqueline Whang-Peng, MD

Role: PRINCIPAL_INVESTIGATOR

Wan Fang Hospital

Locations

Mackay Memorial Hospital

Taipei, , Taiwan

Taipei Veteran General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

TLC388.2

Identifier Type: -

Identifier Source: org_study_id