Clinical trial NCT04967482: DEB-TACE vs. cTACE as Conversion Therapy for Unresectable Large HCC
Official title: Drug-eluting Bead Transarterial Chemoembolization Compared With Conventional Transarterial Chemoembolization as the Conversion Therapy for Unresectable Large Hepatocellular Carcinoma: a Multicenter, Prospective, Nonrandomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma Non-resectable
Keywords: Hepatocellular carcinoma
Transarterial chemoembolization
Conversion therapy
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is conducted to evaluate the efficacy of drug-eluting bead transarterial chemoembolization (DEB-TACE) compared with conventional transarterial chemoembolization (cTACE) as the conversion therapy for unresectable large hepatocellular carcinoma (HCC).

Detailed description: This is a multicenter, prospective and nonrandomized study to evaluate the efficacy of DEB-TACE (with DC Bead) compared with cTACE as the conversion therapy for unresectable large HCC.

At least 216 patients (≥ 108 patients in each arm) with initially unresectable large HCC (\> 7cm) will be enrolled in this study. The patients will receive either DEB-TACE or cTACE as the primary treatment according to their won will. TACE can be repeated on demand based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team, and the technique method of each TACE procedure (i.e. DEB-TACE or cTACE) for the same patient should be consistent. During follow-up, the potential resectability of the tumor will be assessed by the multidisciplinary team (MDT). Once the tumors become resectable, curative surgical resection will be recommended for the patients.

The primary end point of this study is success rate of conversion to resection. The secondary endpoints are objective response rate (ORR) of TACE, progression-free survival (PFS), times of TACE procedure to achieve conversion, conversion time, success rate of surgical resection, tumor recurrence rate after resection, tumor-free survival (TFS) of patients who undergo surgical resection, adverse events (AEs) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

1. Hepatocellular carcinoma confirmed by histopathology and/or cytology, or diagnosed clinically.
2. The tumor lesion was only localized in one liver lobe.
3. Large HCC with single lesion \> 7 cm, or multiple lesions.
4. unresectable HCC evaluated by the surgeon team.
5. The patient is suitable for TACE treatment, which is evaluated by MDT.
6. At least one measurable intrahepatic target lesion.
7. Patients without cirrhosis, or with cirrhosis but the liver function of Child-Pugh Class A.
8. ECOG score of performance status ≤ 1 point.
9. Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×109/L, absolute value of neutrophils \>1.5×109/L, hemoglobin ≥85 g/L, total bilirubin ≤30 μmol/L, albumin ≥35 g/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR\<1.5 or PT/APTT normal range.
10. Patients have the willingness to receive TACE as the conversion therapy for surgical resection.

Exclusion Criteria:

1. Accompanied with tumor thrombus involving the main portal vein, first-order branch or bilateral branches of portal vein.
2. Accompanied with hepatic vein and vena cava tumor thrombus.
3. The extent of the lesion exceeds one liver lobe or extrahepatic metastasis.
4. Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.
5. Those with organs (heart and kidneys) dysfunction who cannot tolerate TACE treatment and surgical hepatectomy.
6. History of other malignancies.
7. Uncontrollable infection.
8. Patients with active hepatitis B must undergo antiviral therapy to control HBV-DNA \<10\^3 IU/mL.
9. HCV patients need to complete the anti-HCV therapy before they are enrolled.
10. History of HIV.
11. Allergic to the drugs involved in the research.
12. Patients with gastrointestinal bleeding within 30 days, or other bleeding\> CTCAE grade 3.
13. History of organ or cells transplantation. Previous treatment with TACE, intra-arterial infusion chemotherapy, radiotherapy, or systemic therapy
14. Those with bleeding tendency.

Primary outcomes:
measure: Success rate of conversion to resection
timeFrame: 2 years.
Secondary outcomes:
measure: Objective response rate (ORR) of TACE treatment
timeFrame: 2 years.
measure: Progression-free survival (PFS)
timeFrame: 3 years.
measure: Times of TACE procedure to achieve conversion
timeFrame: 2 years.
measure: Time for successful conversion
timeFrame: 2 years.
measure: Disease-free survival (TFS) of the patients who undergo resection
timeFrame: 2 years.
measure: Adverse Events (AEs)
timeFrame: 3 years.
measure: Overall survival (OS)
timeFrame: 3 years.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References: