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Lipotecan Based Concurrent Chemoradiotherapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

Primary Purpose

HepatoCellular Carcinoma, Portal Vein Tumor Thrombosis

Status

Terminated

Phase

Phase 1

Locations

Taiwan

Study Type

Interventional

Intervention

Lipotecan

About this trial

This is an interventional treatment trial for HepatoCellular Carcinoma focused on measuring Hepatocellular carcinoma, Portal vein tumor thrombosis, TLC388, Chemoradiotherapy, Lipotecan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients will be males or females
- ≥20 years of age in Taiwan
- ≥18 years old in China
Patients with histologically confirmed HCC or patients who do not have histological diagnosis, but the lesion is larger than 1 cm in a cirrhotic liver with typical HCC image of contrast enhanced CT scan or MRI. If the image characteristic is not typical of HCC, another contrast enhanced image modality should be confirmed for diagnosis.
Patients with PVTT (BCLC stage C) who are not suitable for local therapies
Patients with a measureable targeting lesion
Patients with an anticipated residual life expectancy ≥3 months
Patients who have adequate organ function
Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Patients who are willing to follow birth control requirements during the study treatment and continue until 2 months after the completion of study treatment
Patients willing and able to comply with the study procedures and to sign a written ICF

Exclusion Criteria:

Patients with infiltrative type HCC
Patients with evidence of any extrahepatic metastasis, including but not limited to inferior vena cava thrombosis, bone metastasis, brain metastasis, or regional lymph node metastasis
Patients with a history of West Haven criteria grade III-IV hepatic encephalopathy or ascites
Patients with a history of other malignancy except primary HCC within 3 years prior to the screening visit, excluding skin squamous cell carcinoma or basal cell carcinoma
Patients who fail to follow the radiation dose constraint in any critical organ in the radiotherapy planning
Patients with an inadequately defined hepatic tumor margin for RT planning on MRI or CT that may impact treatment or safety based on investigator's judgment
Patients who have experienced significant allergy or hypersensitivity to the contrast medium for CT or MRI that makes it unsafe to perform the delineation for RT planning
Patients with a history of liver transplantation
Patients with a significant concurrent disease

Sites / Locations

China Medical University Hospital
Taichung Veterans General Hospital
National Taiwan University Hosipital
Taipei Veteran General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lipotecan based chemoradiotherapy

Arm Description

Patients will receive Lipotecan based CCRT. Lipotecan will be given as a 30-minute (±3 minutes) iv infusion qw for 6 weeks at the predefined dose level for each cohort. A total of 6 doses of Lipotecan will be administered to each patient in conjunction with RT at 3.5 Gy per fraction for 16 fractions. During CCRT period, Lipotecan should be given within 2 hours prior to the start of RT, and the Lipotecan and RT should be delivered on the same day, unless any conditions fulfils with the dose interruption standards. Radiotherapy treatment, at the allocated dose level, is only permitted if the normal tissue dose constrain criteria are maintained

Outcomes

Primary Outcome Measures

Maximum tolerated dose determination for Lipotecan based CCRT

To determine maximum tolerated dose for Lipotecan based CCRT in HCC patients with portal vein tumor thrombosis

Best objective response evaluation of portal vein tumor thrombosis

To evaluate the best objective response rate of portal vein tumor thrombosis

Secondary Outcome Measures

Conversion rate (CR) of portal vein tumor thrombosis

To evaluate the conversion rate (CR rate) of PVTT

Best overall response of overall disease

To evaluate the best overall response rate of overall disease

Disease control rate of portal vein tumor thrombosis, liver tumors and overall disease

To evaluate DCR of PVTT, liver tumors (target lesions), and overall disease

Time to progression of overall disease

To evaluate the TTP of overall disease after the start of concomitant Lipotecan based CCRT

Progression free survival of overall disease

To evaluate the PFS of overall disease after the start of concomitant Lipotecan based CCRT

Overall survival of overall disease

To evaluate the OS after the start of concomitant Lipotecan based CCRT

Full Information

NCT ID

NCT03035006

First Posted

January 25, 2017

Last Updated

November 4, 2018

Sponsor

Taiwan Liposome Company

1. Study Identification

Unique Protocol Identification Number

NCT03035006

Brief Title

Lipotecan Based Concurrent Chemoradiotherapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

Official Title

A Phase I/II, Dose-escalation Study of Lipotecan Based Concurrent Chemoradiotherapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Terminated

Why Stopped

Current study design couldn't support futher development on this indication.

Study Start Date

April 14, 2017 (Actual)

Primary Completion Date

October 31, 2018 (Actual)

Study Completion Date

October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taiwan Liposome Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a phase I/II dose-escalation study of lipotecan based concurrent chemoradiotherapy in hepatocellular carcinoma with portal vein tumor thrombosis.

Detailed Description

Protocol number: TLCTLC388A1008 Primary objective: To evaluate the safety and tolerability, including maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), of Lipotecan based concurrent chemoradiotherapy (CCRT) in patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT) unsuitable for local treatment. Secondary Objective: The secondary objective is to explore the efficacy of Lipotecan based CCRT in patients with HCC and PVTT and the effect on quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HepatoCellular Carcinoma, Portal Vein Tumor Thrombosis

Keywords

Hepatocellular carcinoma, Portal vein tumor thrombosis, TLC388, Chemoradiotherapy, Lipotecan

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lipotecan based chemoradiotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Lipotecan

Other Intervention Name(s)

TLC388

Intervention Description

Lipotecan based concurrent chemoradiotherapy

Primary Outcome Measure Information:

Title

Maximum tolerated dose determination for Lipotecan based CCRT

Description

To determine maximum tolerated dose for Lipotecan based CCRT in HCC patients with portal vein tumor thrombosis

Time Frame

3 months

Title

Best objective response evaluation of portal vein tumor thrombosis

Description

To evaluate the best objective response rate of portal vein tumor thrombosis

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Conversion rate (CR) of portal vein tumor thrombosis

Description

To evaluate the conversion rate (CR rate) of PVTT

Time Frame

1 year

Title

Best overall response of overall disease

Description

To evaluate the best overall response rate of overall disease

Time Frame

1 year

Title

Disease control rate of portal vein tumor thrombosis, liver tumors and overall disease

Description

To evaluate DCR of PVTT, liver tumors (target lesions), and overall disease

Time Frame

1 year

Title

Time to progression of overall disease

Description

To evaluate the TTP of overall disease after the start of concomitant Lipotecan based CCRT

Time Frame

1 year

Title

Progression free survival of overall disease

Description

To evaluate the PFS of overall disease after the start of concomitant Lipotecan based CCRT

Time Frame

1 year

Title

Overall survival of overall disease

Description

To evaluate the OS after the start of concomitant Lipotecan based CCRT

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients will be males or females ≥20 years of age in Taiwan ≥18 years old in China Patients with histologically confirmed HCC or patients who do not have histological diagnosis, but the lesion is larger than 1 cm in a cirrhotic liver with typical HCC image of contrast enhanced CT scan or MRI. If the image characteristic is not typical of HCC, another contrast enhanced image modality should be confirmed for diagnosis. Patients with PVTT (BCLC stage C) who are not suitable for local therapies Patients with a measureable targeting lesion Patients with an anticipated residual life expectancy ≥3 months Patients who have adequate organ function Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤2 Patients who are willing to follow birth control requirements during the study treatment and continue until 2 months after the completion of study treatment Patients willing and able to comply with the study procedures and to sign a written ICF Exclusion Criteria: Patients with infiltrative type HCC Patients with evidence of any extrahepatic metastasis, including but not limited to inferior vena cava thrombosis, bone metastasis, brain metastasis, or regional lymph node metastasis Patients with a history of West Haven criteria grade III-IV hepatic encephalopathy or ascites Patients with a history of other malignancy except primary HCC within 3 years prior to the screening visit, excluding skin squamous cell carcinoma or basal cell carcinoma Patients who fail to follow the radiation dose constraint in any critical organ in the radiotherapy planning Patients with an inadequately defined hepatic tumor margin for RT planning on MRI or CT that may impact treatment or safety based on investigator's judgment Patients who have experienced significant allergy or hypersensitivity to the contrast medium for CT or MRI that makes it unsafe to perform the delineation for RT planning Patients with a history of liver transplantation Patients with a significant concurrent disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carl Brown, PhD

Organizational Affiliation

Taiwan Liposome Company

Official's Role

Study Director

Facility Information:

Facility Name

China Medical University Hospital

City

Taichung

Country

Taiwan

Facility Name

Taichung Veterans General Hospital

City

Taichung

Country

Taiwan

Facility Name

National Taiwan University Hosipital

City

Taipei

Country

Taiwan

Facility Name

Taipei Veteran General Hospital

City

Taipei

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Lipotecan Based Concurrent Chemoradiotherapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

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