TACTICS-L

JRCT ID: jRCTs031180074

Registered date:10/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma(HCC)
• Date of first enrollment: 05/02/2019
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Chemotherapy

Outcome(s)

• Primary Outcome: Progression-free survival(PFS)
• Secondary Outcome: Time To Untreatable Progression(TTUP),Progression-free survival; PFS,Overall response rate;ORR,Overall survival;OS and Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Men and women aged > 20 years.
2) Patients who provide written informed consent to participation in this study after receiving a detailed explanation before enrollment.
3) Patients expected to survive for >= 12 weeks.
4) Patients with a diagnosis of HCC by biopsy, cytology, or diagnostic imaging studies such as dynamic CT (MRI). Diagnosis of HCC is performed according to the American Association for the Study of Liver Diseases (AASLD) guidelines.
5) Patients in whom complete resection was not achieved at hepatectomy or complete necrosis was not achieved by local ablative therapy.
6) Patients with no previous systemic chemotherapy, hepatic arterial infusion therapy, or immunotherapy for the treatment of HCC.
7) Patients with no more than 10 liver tumors, all of which can be treated by TACE (maximum tumor diameter <= 10 cm, excluding lesions with necrosis after local treatment and unmeasurable lesions).
8) Patients who have undergone up to two TACE procedure.
9) Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
10) Patients with good blood pressure control irrespective of antihypertensive therapy.
11) Patients with a Child-Pugh score <= 6
12) Patients who meet the laboratory criteria.

Exclude criteria

1) Patients with previous or current malignancy.
2) Patients with serious heart disease.
3) Patients with serious active infection. (Infection with HBV or HCV is excluded.)
4) Patients with a history of human immunodeficiency virus (HIV) infection.
5) Patients on renal dialysis.
6) Patients with diffuse tumors.
7) Patients with extrahepatic metastasis.
8) Patients with vascular invasion.
9) Patients with intracranial tumors, including intracranial metastases.
10) Patients with previous or current hepatic encephalopathy.
11) Patients with clinically uncontrolled ascites or pleural effusion.
12) Patients who have had clinically significant gastrointestinal bleeding within 4 weeks before enrollment.
13) Patients with gastroesophageal varices at risk of bleeding.
14) Patients with thromboembolic disorders within 6 months before enrollment.
15) Patients who have undergone any of the following procedures:
a) Systemic chemotherapy for treatment of advanced hepatocellular carcinoma (including prior treatment with lenvatinib).
b) Local tumor treatment, such as radiofrequency ablation or intra-arterial chemotherapy, within 3 months before enrollment.
c) Invasive surgery, such as open-heart surgery or laparotomy (including hepatectomy), within 4 weeks before enrollment.
d) Previous organ transplantation.
e) Bone marrow transplantation or hematopoietic stem cell transplantation within 4 weeks before enrollment.
16) Patients who cannot tolerate oral administration.
17) Patients with gastrointestinal diseases that may affect the absorption and pharmacokinetics of drugs.
18) Patients using medications that may affect the absorption and pharmacokinetics of drugs.
19) Patients with concomitant diseases/disorders that may influence the evaluation of study drug efficacy.
20) Patients who have participated in another clinical study within 4 weeks before enrollment in this study.
21) Women who are pregnant, breastfeeding, of childbearing potential, or wish to become pregnant. (A woman who is suspected to be pregnant must have a negative pregnancy test before enrollment.)
22) Patients who may be allergic to the study drugs.
23) Patients with substance abuse or other health, psychological, and social problems that may preclude participation in this study and appropriate evaluation of the results.
24) Patients whose safety may be compromised during this study or patients who are considered likely to have difficulty complying with the protocol.
25) Any subject who cannot be evaluated by either triphasic liver CT or triphasic liver MRI because of allergy or other contraindication to both CT and MRI contrast agents

Related Information

• Primary Sponsor: Kudo Masatoshi
• Secondary Sponsor: Eisai Co.Ltd.