Irradiation Stent Placement Plus TACE for HCC and PVTT

NCT03730675 | Unknown DMC

• 1 other identifier: ZhongdaH-PATENCY
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a multicenter, randomized (1:1), open-label, parallel-arm, Phase 3 clinical trial to evaluate the efficacy and safety of portal irradiation stent placement plus TACE compared to sorafenib plus TACE in patients with advanced HCC accompanied by portal vein tumor thrombosis. Patients will be randomized to receive either portal irradiation stent placement plus TACE(Arm A) or Sorafenib plus TACE (Arm B).

Conditions

Hepatocellular Carcinoma; Portal Vein Tumor Thrombosis

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival was measured from the date of randomization until the date of death from any cause.

  up to 36 months

Secondary Outcomes (5)

• Hepatic function in terms of albumin and total bilirubin

  up to 36 months

• Time to symptomatic progression

  up to 36 months

• Patency of portal vein

  up to 36 months

• Disease control rate of intrahepatic lesions

  up to 36 months

• Treatment Safety in terms of type, incidence, severity timing, seriousness, and relatedness of adverse events and laboratory abnormalities

  up to 36 months

Study Arms (2)

irradiation stent plus TACE

EXPERIMENTAL

Portal irradiation stent placement will be performed before TACE procedures.

Procedure: Portal irradiation stent placement; Procedure: TACE

Sorafenib plus TACE

ACTIVE COMPARATOR

TACE will be performed in patients randomized to Arm B, with sequential sorafenib.

Procedure: TACE; Drug: Sorafenib

Interventions

Portal irradiation stent placement PROCEDURE

The irradiation portal vein stent was designed as two separate parts that consisted of an outer seeds-loaded-stent and an inner self-expandable metallic stent

irradiation stent plus TACE

TACE PROCEDURE

TACE is a minimally invasive procedure performed in interventional radiology to restrict a tumor's blood supply.

Sorafenib plus TACE; irradiation stent plus TACE

Sorafenib DRUG

Sorafenib is a kinase inhibitor drug approved for the treatment of advanced hepatocellular carcinoma.

Sorafenib plus TACE

Eligibility Criteria

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

You may qualify if:

• Histologically-confirmed or clinical diagnosis of hepatocellular carcinoma (HCC)
• Histologically-confirmed or imaging-based diagnosis malignant portal vein tumor thrombosis(PVTT)
• Portal trunk invaded tumor thrombosis without the infiltration of superior mesenteric vein or inferior caval vein
• At least one patent first branch of the portal vein
• Measurable intrahepatic disease according to mRECIST
• Child-Pugh class A or B
• Eighteen years of age or older
• With an expected lifespan more than 3 months
• ECOG performance status 0, 1 or 2
• Required baseline laboratory data within the following parameters:
• \. Neutrophils ≥ 1.0×10⁹/L 2. Platelets ≥ 50×10⁹ /L 3. Hemoglobin ≥ 90 g/L 4. Serum aspartate aminotransferase (AST; ALT≤5 x ULN) 5. Serum creatinine ≤1.5 x ULN 6. INR \<1.7 or prothrombin time (PT) \< 4 seconds above ULN 7. Total bilirubin \< 34.2 umol/L(2 mg/dL) 11. Signed and dated informed consent and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

You may not qualify if:

• Presence of distant metastasis outside liver or diagnosis of any second malignancy beyond HCC
• Less than 30% volume of uninvolved liver
• Prior systemic treatment, including prior treatment with sorafenib or any prior local therapy (such as surgery, radiation therapy, hepatic arterial embolization, TACE, hepatic arterial infusion, radiofrequency ablation, percutaneous ethanol injection or cry ablation)
• Presence of clinically relevant ascites (that can be classified as Child-Pugh score of 3).
• Documented variceal hemorrhage within 6 months of study entry or presence of esophageal varices at risk of bleeding (as documented by endoscopy/CT/fluoroscopy)
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study entry
• Any of the following within the 3 months prior to study drug administration: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, including transient ischemic attack, or pulmonary embolism.
• Ongoing cardiac dysrhythmias of NCI CTCAE grade≥2, atrial fibrillation of any grade, or prolongation of the QTc interval to \> 450 msec for males or \> 470 msec for females.
• Hypertension that cannot be controlled by medications (blood pressure \>150/100 mm Hg despite optimal medical therapy).
• Concomitant treatment with botanical formulation having an approved indication for cancer treatment, such as "Xiao Chai Hu Tang", "Kanglaite", "Huai Er Ke Li"etc.
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
• Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to study enrollment.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhong-da Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

Related Publications (1)

• Lu J, Guo JH, Ji JS, Li YL, Lv WF, Zhu HD, Sun JH, Ren WX, Zhang FJ, Wang WD, Shao HB, Cao GS, Li HL, Gao K, Yang P, Yin GW, Zhu GY, Wu FZ, Wang WJ, Lu D, Chen SQ, Min J, Zhao Y, Li R, Lu LG, Lau WY, Teng GJ. Irradiation stent with 125 I plus TACE versus sorafenib plus TACE for hepatocellular carcinoma with major portal vein tumor thrombosis: a multicenter randomized trial. Int J Surg. 2023 May 1;109(5):1188-1198. doi: 10.1097/JS9.0000000000000295.

  PMID: 37038986 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

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)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Gao-Jun Teng, M.D.

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Lu, M.D.

CONTACT

86+15850654644; lujian43307131@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: October 28, 2018
• First Posted: November 5, 2018
• Study Start: November 10, 2018
• Primary Completion: November 10, 2021
• Study Completion: November 10, 2021
• Last Updated: December 21, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)