Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03035006
Recruitment Status : Terminated (Current study design couldn't support futher development on this indication.)
First Posted : January 27, 2017
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Taiwan Liposome Company

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

Condition or disease Intervention/treatment Phase
HepatoCellular Carcinoma Portal Vein Tumor Thrombosis Drug: Lipotecan Phase 1 Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Dose-escalation Study of Lipotecan Based Concurrent Chemoradiotherapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
Actual Study Start Date : April 14, 2017
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
Experimental: Lipotecan based chemoradiotherapy
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
Drug: Lipotecan
Lipotecan based concurrent chemoradiotherapy
Other Name: TLC388




Primary Outcome Measures :
  1. Maximum tolerated dose determination for Lipotecan based CCRT [ Time Frame: 3 months ]
    To determine maximum tolerated dose for Lipotecan based CCRT in HCC patients with portal vein tumor thrombosis

  2. Best objective response evaluation of portal vein tumor thrombosis [ Time Frame: 1 year ]
    To evaluate the best objective response rate of portal vein tumor thrombosis


Secondary Outcome Measures :
  1. Conversion rate (CR) of portal vein tumor thrombosis [ Time Frame: 1 year ]
    To evaluate the conversion rate (CR rate) of PVTT

  2. Best overall response of overall disease [ Time Frame: 1 year ]
    To evaluate the best overall response rate of overall disease

  3. Disease control rate of portal vein tumor thrombosis, liver tumors and overall disease [ Time Frame: 1 year ]
    To evaluate DCR of PVTT, liver tumors (target lesions), and overall disease

  4. Time to progression of overall disease [ Time Frame: 1 year ]
    To evaluate the TTP of overall disease after the start of concomitant Lipotecan based CCRT

  5. Progression free survival of overall disease [ Time Frame: 1 year ]
    To evaluate the PFS of overall disease after the start of concomitant Lipotecan based CCRT

  6. Overall survival of overall disease [ Time Frame: 1 year ]
    To evaluate the OS after the start of concomitant Lipotecan based CCRT



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients will be males or females

    • ≥20 years of age in Taiwan
    • ≥18 years old in China
  2. 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.
  3. Patients with PVTT (BCLC stage C) who are not suitable for local therapies
  4. Patients with a measureable targeting lesion
  5. Patients with an anticipated residual life expectancy ≥3 months
  6. Patients who have adequate organ function
  7. Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  8. Patients who are willing to follow birth control requirements during the study treatment and continue until 2 months after the completion of study treatment
  9. Patients willing and able to comply with the study procedures and to sign a written ICF

Exclusion Criteria:

  1. Patients with infiltrative type HCC
  2. 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
  3. Patients with a history of West Haven criteria grade III-IV hepatic encephalopathy or ascites
  4. 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
  5. Patients who fail to follow the radiation dose constraint in any critical organ in the radiotherapy planning
  6. 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
  7. 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
  8. Patients with a history of liver transplantation
  9. Patients with a significant concurrent disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035006


Locations
Layout table for location information
Taiwan
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hosipital
Taipei, Taiwan
Taipei Veteran General Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taiwan Liposome Company
Investigators
Layout table for investigator information
Study Director: Carl Brown, PhD Taiwan Liposome Company

Layout table for additonal information
Responsible Party: Taiwan Liposome Company
ClinicalTrials.gov Identifier: NCT03035006     History of Changes
Other Study ID Numbers: TLC388A1008
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Taiwan Liposome Company:
Hepatocellular carcinoma
Portal vein tumor thrombosis
TLC388
Chemoradiotherapy
Lipotecan

Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Hepatocellular
Thrombosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases