TACE Combined With Iodine-125 Seeds Implantation for HCC

NCT03322280 | Unknown DMC

• 1 other identifier: MIIR-01
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

Portal vein tumour thrombus (PVTT) is a common complication of hepatocellular carcinoma (HCC). PVTT has a profound adverse effect on prognosis, with a very short median survival time (2-4 months). The presence of PVTT also limits treatment options, such as liver transplantation and curative resection. Although the Barcelona Clinic Liver Cancer group recommended sorafenib as a standard therapy for advanced-stage HCC, the optimal treatment for HCC with PVTT remains largely controversial. Some studies have reported a survival benefit in patients with PVTT who underwent transarterial chemoembolization (TACE), even in patients with main portal vein (MPV) tumor thrombus. Iodine-125 brachytherapy had also showed promising efficacy as a new method for unresectable HCC with PVTT. Results of our previous study indicated that TACE combined with Iodine-125 seeds implantation might be a good choice for selected patients with PVTT. Thus, we conduct this study to farther evaluate the effect of TACE combined with Iodine-125 seeds implantation for HCC with PVTT. 270 patients with HCC and PVTT will be included and randomized to two group: group 1, patients received TACE combined with Iodine-125 seeds implantation; group 2, patients received TACE alone. TACE and Iodine-125 seeds implantation will be performed with a standardized procedure. Iodine-125 seeds implantation into PVTT (guided by CT) will be conducted 7 days after TACE. All patients revisit our institutions for follow-up examinations including contrast enhanced CT/MRI and laboratory tests every 4-6 weeks after the first treatment. Patients who have a tumor response rating of complete response will be required to revisit 3 months interval. At each visit, TACE or Iodine-125 seeds implantation is repeated if the following criteria are reached: 1) images indicating viable intrahepatic tumor tissue or PVTT; 2) Child-Pugh class A or B, and no contraindication to TACE and Iodine-125 seeds implantation. The primary end point of this study is overall survival. The secondary end points are time to tumor progression, disease control rate, duration of portal patency and adverse events. All adverse events are graded in accordance with Common Toxicity Criteria Adverse Events Version (CTCAE) 4.03.

Conditions

Hepatocellular Carcinoma; Portal Vein Occlusion; Tumor Thrombus

Keywords

Hepatocellular carcinoma; Portal vein tumor thrombus; Transcatheter arterial chemoembolization; iodine-125 seed

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  The time from date of randomization to death due to any cause.

  24 months

Secondary Outcomes (6)

• Adverse events

  24 months

• Progression free survival (PFS)

  24 months

• Time to tumor progression (TTP)

  24 months

• Objective response rate (ORR)

  24 months

• Disease control rate (DCR)

  24 months

Study Arms (2)

TACE+I-125 seeds

EXPERIMENTAL

TACE combined with iodine-125 seeds implantation

Procedure: TACE combined with iodine-125 seeds implantation

TACE alone

ACTIVE COMPARATOR

TACE alone

Procedure: TACE

Interventions

TACE combined with iodine-125 seeds implantation PROCEDURE

Conventional TACE with lipiodol was performed. Then Iodine-125 seed implantation into PVTT is conducted 7-10 days after TACE when liver function tests demonstrated values comparable to those obtained before TACE.

TACE+I-125 seeds

TACE PROCEDURE

Only conventional TACE with lipiodol and chemotherapy drugs was performed.

TACE alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of HCC;
• age between18 and 75 years;
• type I PVTT, type II PVTT, or type III PVTT within 1.5cm extending in the main portal vein (if obstructive PVTT involve both the left and right portal vein or main portal vein, multiple collateral vessels are required);
• Child-Pugh class A or B;
• Eastern Cooperative Group performance status (ECOG) score of 0-2;
• neutrophilic granulocyte count ≥ 1.5×10\^9/L, platelet count ≥ 30×10\^9/L, and hemoglobin level ≥ 85g/L;
• serum bilirubin ≤ 51.3 μmol/L, albumin ≥ 28g/L, ALT and AST ≤ 5 times of the upper normal limit, and creatinine ≤ 20g/L;
• prothrombin time ≤18s or international normalized ratio \< 1.7.

You may not qualify if:

• diffuse HCC;
• extrahepatic metastasis;
• obstructive PVTT involving both the left and right portal vein or main portal vein without collateral vessels,
• type III PVTT affecting the main portal vein more than 1.5cm, or type IV PVTT;
• previously surgery (resection or liver transplantation), local-regional therapies (e.g., radiofrequency ablation), intra-arterial chemoinfusion, TACE, radiotherapy, systemic chemotherapy, or molecular targeted drug therapy for HCC;
• serious medical comorbidities.

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead
• ZhuHai Hospital: collaborator
• The First People's Hospital of Zhaoqing: collaborator
• Foshan Sanshui District People's Hospital: collaborator
• Fifth Affiliated Hospital, Sun Yat-Sen University: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Sun Yat-sen University: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (1)

The 2nd Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

Related Publications (20)

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MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Kangshun Zhu, MD

  Second Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: October 26, 2017
• Study Start: July 1, 2018
• Primary Completion: September 18, 2021
• Study Completion: June 30, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-03

Locations

CN (1)