Transcatheter Arterial Chemoembolization (TACE) in Combination With Arsenic Trioxide Versus TACE in the Treatment of Middle-advanced Primary Hepatocellular Carcinoma (HCC) Patients

NCT02956772 | Unknown Phase 2

• 1 other identifier: RACE16001
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 9

Brief Summary

A multicentre, randomized, open-label, parallel-group, active controlled study.

Conditions

Primary Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Progression free survival (PFS) is defined as the time interval from the day of the random assignment to the first evidence of progression or death.

  2-year

Secondary Outcomes (3)

• Objective response rate

  2-year

• Overall Survival

  2-year

• Incidence of adverse events

  Up to 2 years through study completion

Other Outcomes (1)

• Quality of life using EuroQol five dimensions five levels questionnaire

  Baseline and week 6, 12, 18, 24 and 30 using EuroQol five dimensions five levels questionnaire

Study Arms (2)

TACE plus Arsenic Trioxide

EXPERIMENTAL

Patients in this group are to receive a single dose of TACE treatment on day 1, followed by arsenic trioxide at 10 mg/day for 14 days (day 8-21). TACE treatment is repeated every 9 weeks while arsenic trioxide every 3 weeks for treatment duration of 27 weeks. At least 3 cycles of arsenic trioxide are administrated.

Drug: TACE; Drug: Arsenic trioxide

TACE

ACTIVE COMPARATOR

Patients in this group are to receive a single dose of TACE treatment on day 1. TACE treatment is repeated every 9 weeks for 27 weeks.

Drug: TACE

Interventions

TACE DRUG

After the puncture of femoral artery via Seldinger method, a catheter was inserted and digital celiac axis or hepatic arteriography performed. Then a microcatheter was used to infuse chemotherapeutic agent (30 to 60 mg of pirarubicin) mixed with 5 to 20 mL of Lipiodol Ultra-Fluid. Embosphere microspheres (size of 100 to 300 um) were inserted for embolization.

TACE; TACE plus Arsenic Trioxide

Arsenic trioxide DRUG

Arsenic trioxide 10 mg is put into 500 ml saline solution and then administrated by continuous intravenous drip for 5 hours during a treatment day.

TACE plus Arsenic Trioxide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

1. Subject is 18-80 years old. 2. Subject has no portal stem vein tumor thrombus. 3. Subject has primary middle-advanced liver cancer of Barcelona Clinic Liver Cancer stages B/C inappropriate for surgical resection or other locoregional therapy and still presents with tumor lesions in the liver. 4. Subject has evaluable tumor lesion(s) (using Magnetic Resonance Imaging /Computed Tomography) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1: single lesion size ≥5cm or at least one lesion of \>3cm in size when 2-3 lesions exist or there are 4 or more lesions. 5. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤1, Fibrosis index based on 4 factors (FIB-4)≤6 and an expected survival time of 12 weeks or more. 6. Haematology: white blood cell count ≥3.0×10\^9/L; hemoglobin≥10 g/dL; blood platelet count≥80×10\^9/L 7. Blood biochemistry: serum albumin ≥2.8 g/dL, total bilirubin ≤2 mg/dL or ≤34.2 umol/L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 times of upper limit of normal (ULN); amylase and lipase ≤ 1.5 times of ULN; serum creatinine ≤2.0 mg/dL or \< 1.5 times of ULN; estimated creatinine clearance ≥60 mL/min. 8. International normalized ratio (INR) is ≤ 2.3 or prothrombin time (PT) is ≤3 seconds than upper limit of normal control. 9. Echocardiogram indicated a left ventricular ejection fraction (LVEF) of \>50%. 10. Subject has a liver function Child-Pugh class A or B. 11. Subject is not pregnant or lactating. 12. Female subjects must be infertile or agree to take effective contraceptives; male subjects and their partners of reproductive potential must also agree to use appropriate contraceptives. 13. Subject had no second tumor in the last 5 years, excluding skin basal cell carcinoma or skin squamous carcinoma or any other carcinoma in situ. 14. Subject had no history of systemic chemotherapy. 15. Subject has no any other concomitant anticancer therapies, such as local radiotherapy, systemic chemotherapy and molecular targeted therapy. 16. Subject and (or) guardian is able to understand this study and willing to provide written, informed consent to participate in this clinical study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Hunan Provincial People's Hospital: lead

Study Sites (9)

Guizhou Cancer Hospital

Guiyang, Guizhou, China

Location

Guizhou Province Tumor Hospital

Guiyang, Guizhou, China

Location

Hunan Provincial People's Hospital

Changsha, Hunan, 410001, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, China

Location

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

Xinjiang Medical University Cancer Hospital

Ürümqi, Xinjiang, China

Location

The Tumor Hospital of Yunnan Province

Kunming, Yunnan, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Arsenic Trioxide

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

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• Hua Xiang, Dr.

  Hunan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Long, Dr.

CONTACT

86-13507476175

Hua Xiang, Dr.

CONTACT

85-13667367061

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 7, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2020
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)