Hepatocellular Carcinoma Non-resectable Clinical Trial
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
NCT number | NCT04967482 |
Other study ID # | MIIR-06 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 9, 2021 |
Est. completion date | July 8, 2024 |
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).
Status | Recruiting |
Enrollment | 216 |
Est. completion date | July 8, 2024 |
Est. primary completion date | July 8, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | the Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital of Guangzhou Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Success rate of conversion to resection | The proportion of patients with initially unresectable large HCC who were evaluated by the surgical team as suitable for second-stage surgical resection after TACE treatment. | 2 years. | |
Secondary | Objective response rate (ORR) of TACE treatment | The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) which is assessed by the investigators according to modified Response Evaluaion Criteria in Solid Tumors (mRECIST). | 2 years. | |
Secondary | Progression-free survival (PFS) | The time between the first TACE treatment and the first occurrence of disease progression (PD) or death from any cause, whichever occurs first. For the patients who receive surgical resection after TACE, PD is defined as tumor recurrence/metastasis after resection. For the patients who did not undergo surgical resection, PD is assessed by the investigators according to mRECIST. | 3 years. | |
Secondary | Times of TACE procedure to achieve conversion | The number of TACE procedures performed for the patients when thier tumors become resectable. Resectability of the tumor is assessed by MDT during follow-up. | 2 years. | |
Secondary | Time for successful conversion | The duration between the first TACE treatment and the resectability of the tumor. Resectability is assessed by MDT. | 2 years. | |
Secondary | Disease-free survival (TFS) of the patients who undergo resection | The time between surgical resection and the first tumor recurrence/metastasis or death from any cause, whichever occurs first.. | 2 years. | |
Secondary | Adverse Events (AEs) | Number of patients with AE, treatment-related AE (TRAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0. | 3 years. | |
Secondary | Overall survival (OS) | The time from first TACE until the date of death from any cause. | 3 years. |
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