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

Carcinoma, Hepatocellular Clinical Trial

Official title:

A Phase I/II, Dose-escalation Study of Lipotecan® Plus Radiotherapy in Locally Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01425996
• Other study ID #: TLC388.2
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: October 27, 2011
• Est. completion date: October 3, 2014

Study information

• Verified date: August 2018
• Source: Taiwan Liposome Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 3, 2014
• Est. primary completion date: October 3, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

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

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	Taipei Veteran General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taiwan Liposome Company

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD)	Maximum tolerated dose	week 12
Primary	PVTT response rate	PVTT response rate	week7
Primary	Dose-limiting toxicity (DLT)	Dose-limiting toxicity	week 12
Primary	Adverse Event/Serious Adverse Event	Serious/ Adverse Event	week 12
Secondary	Hepatic tumor response rate (overall tumor response rate)	Hepatic tumor response rate (overall tumor response rate)	week7, week12
Secondary	Tumor downstaging rate	Tumor downstaging rate	week7, week12
Secondary	Time to progression (TTP)	Time to progression	week7, week12, 1 year
Secondary	Progression-free survival (PFS)	Progression-free survial	week7, week12, 1 year
Secondary	Overall survival (OS)	Overall survival	week7, week12, 1year
Secondary	Change from baseline in tumor marker/biomarkers	Change from baseline in tumor marker/biomarkers	week4, week7, week12