Clinical trial NCT03035006: 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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: HepatoCellular Carcinoma
Portal Vein Tumor Thrombosis
Keywords: Hepatocellular carcinoma
Portal vein tumor thrombosis
TLC388
Chemoradiotherapy
Lipotecan
Lead sponsor: Taiwan Liposome Company
Sponsor class: INDUSTRY
First posted: 2017-01-27
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Maximum tolerated dose determination for Lipotecan based CCRT
timeFrame: 3 months
measure: Best objective response evaluation of portal vein tumor thrombosis
timeFrame: 1 year
Secondary outcomes:
measure: Conversion rate (CR) of portal vein tumor thrombosis
timeFrame: 1 year
measure: Best overall response of overall disease
timeFrame: 1 year
measure: Disease control rate of portal vein tumor thrombosis, liver tumors and overall disease
timeFrame: 1 year
measure: Time to progression of overall disease
timeFrame: 1 year
measure: Progression free survival of overall disease
timeFrame: 1 year
measure: Overall survival of overall disease
timeFrame: 1 year
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hosipital
city: Taipei
country: Taiwan
facility: Taipei Veteran General Hospital
Study officials:
affiliation: Taiwan Liposome Company
name: Carl Brown, PhD
role: STUDY_DIRECTOR
References: