DEB-TACE Versus DEB-TACE Sequential HAIC for Unresectable BCLC Stage C HCC; A Randomized Controlled Trial

NCT05788835 | Recruiting

• 1 other identifier: 2023-KY-0081-002
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 16

Brief Summary

This is a randomized controlled trial to determine the efficacy and safety of DEB-TACE versus DEB-TACE sequential HAIC for unresectable BCLC stage C HCC

Conditions

HCC

Keywords

DEB-TACE- HAIC; DEB-TACE

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Time from the first DEB-TACE treatment to either radiological progression or death

  Time from the first DEB-TACE treatment to either radiological progression or death or up to 36 months

Secondary Outcomes (4)

• Overall survival (OS)

  Time from the first DEB-TACE treatment to death or up to 36 months

• Objective response rate (ORR)

  1, 3, 6,12 months after the first DEB-TACE treatment, up to death or 36 months, whichever came first

• Disease control rate (DCR)

  1, 3, 6,12 months after the first DEB-TACE treatment, up to death or 36 months, whichever came first

• Time to Progression (TTP)

  Time from the first DEB-BACE treatment to either radiological progression up to 36 months

Study Arms (2)

DEB-TACE-HAIC

EXPERIMENTAL

Drug-eluting bead transarterial chemoembolization Sequential with FOLFOX-based chemotherapy hepatic artery infusion

Procedure: DEB-TACE and HAIC

DEB-TACE

ACTIVE COMPARATOR

Drug-eluting bead transarterial chemoembolization

Procedure: DEB-TACE

Interventions

DEB-TACE and HAIC PROCEDURE

Drug-eluting bead transarterial chemoembolization sequential Hepatic Artery Chemotherapy Infusion

DEB-TACE-HAIC

DEB-TACE PROCEDURE

Drug-eluting bead transarterial chemoembolization

DEB-TACE

Eligibility Criteria

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

You may qualify if:

• Patient with unresectable HCC who strictly meet the clinical diagnostic criteria of the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) or who have been confirmed by histopathology or cytology, There was at least one measurable lesion (according to the requirements of mRECIST 1.1, the spiral CT scan diameter of the measurable lesion was ≥10mm or the short diameter of enlarged lymph node was ≥15mm).
• The sum of the diameter of single or 2-3 tumors ≥5cm. Tumor stage: Stage C of BCLC.
• Patient age between 18 and 75，male or female.
• ECOG 0-1.
• Expected life span ≥ 3 months.
• No history of severe comorbidities, such as hypertension, coronary heart disease, and mental illness, and no history of severe allergies.
• Child-Pugh A-B.
• HBV DNA\<2000 IU/ml.
• Women of childbearing age must undergo a pregnancy test within 7 days prior to enrollment.
• Patients sign informed consent, good compliance, cooperate with treatment.

You may not qualify if:

• Imaging examinations were conducted for HCC patients with large liver tumors (≥60% of liver volume), or carcinoma thrombus in main portal vein (occupying ≥50% of vascular diameter), or carcinoma thrombus invading mesenteric vein or inferior vena cava, or significant arteriovenous/venous fistula.
• Before participating in this study, she had received local treatment such as TACE, external radiotherapy and radioactive particle implantation, and had undergone systemic chemotherapy, oral liver cancer targeting drugs (Sorafenib, Lenfacitinib, Apatinib) and immunotherapy such as PD-1/PD-L1/CDLA-4.
• Diffuse liver cancer patients.
• Patients with grade Ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450ms for men and 470ms for women.
• A history of gastrointestinal bleeding within the past 6 months or a definite tendency to gastrointestinal bleeding.
• Abnormal clotting function, bleeding tendency or receiving thrombolytic or anticoagulant therapy.
• Patients with central nervous system metastases or known brain metastases. Co-infected patients with HIV; Pregnant or lactating patients. Patients preparing for liver transplantation (other than those with previous liver transplantation.
• Systemic failure, estimated survival time \<3 months.
• Severe renal dysfunction.
• The patients could not complete the treatment plan due to various reasons, and lost control within three months after enrollment.

Sponsors & Collaborators

• Xuhua Duan: lead

Study Sites (16)

Luo He Central Hospital

Luohe, Henan, China

RECRUITING

Luo Yang Central Hospital

Luoyang, Henan, China

RECRUITING

Deng zhou People's Hospital

Nanyang, Henan, China

RECRUITING

Nan Yang Central Hospital

Nanyang, Henan, China

RECRUITING

General Hospital of Pingmei Shenma Group

Pingdingshan, Henan, China

RECRUITING

First People's Hospital of Shangqiu

Shangqiu, Henan, China

RECRUITING

Shangqiu Municipal Hospital

Shangqiu, Henan, China

RECRUITING

Xin Yang Central Hospital

Xinyang, Henan, China

RECRUITING

The Fifth Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

Zhengzhou Central Hospital

Zhengzhou, Henan, China

RECRUITING

Zhou Kou Central Hospital

Zhoukou, Henan, China

RECRUITING

First People's Hospital of Zhu Madian

Zhumadian, Henan, China

RECRUITING

Zhu Ma Dian Central Hospital

Zhumadian, Henan, China

RECRUITING

Zhu Madian Traditional Chinese Medicine Hospital

Zhumadian, Henan, China

RECRUITING

Second People's Hospital of Jiaozuo

Jiaozuo, China

RECRUITING

Study Officials

• Xuhua Xuhua, Ph.D.

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuhua Duan, Ph.D.

CONTACT

+8613523402912; xuhuaduan@163.com

Study Design

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

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: March 7, 2023
• Primary Completion: June 7, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

CN (16)