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

NCT03035006 | Terminated Phase 1 DMC

• 1 other identifier: TLC388A1008
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

HepatoCellular Carcinoma; Portal Vein Tumor Thrombosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  3 months

• Best objective response evaluation of portal vein tumor thrombosis

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

  1 year

Secondary Outcomes (6)

• Conversion rate (CR) of portal vein tumor thrombosis

  1 year

• Best overall response of overall disease

  1 year

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

  1 year

• Time to progression of overall disease

  1 year

• Progression free survival of overall disease

  1 year

Study Arms (1)

Lipotecan based chemoradiotherapy

EXPERIMENTAL

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

Interventions

Lipotecan DRUG

Lipotecan based concurrent chemoradiotherapy

Also known as: TLC388

Lipotecan based chemoradiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taiwan Liposome Company: lead

Study Sites (4)

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Taiwan University Hosipital

Taipei, Taiwan

Location

Taipei Veteran General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

TLC 388

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Carl Brown, PhD

  Taiwan Liposome Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 27, 2017
• Study Start: April 14, 2017
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

TW (4)