Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC

NCT06609876 | Recruiting

• 1 other identifier: Liver Projiect1
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to evaluate the efficacy and safety of low-dose adjuvant donafenib after thermal ablation for early recurrent HCC within Milan criteria.

Conditions

Hepatocellular Carcinoma; Microwave Ablation; Donafenib; Recurrent Tumor

Outcome Measures

Primary Outcomes (1)

• Tumor-free survival rate

  Progression was defined as progressive disease after thermal ablation by independent radiologic review according to mRECIST or death from any cause

  24 months

Secondary Outcomes (2)

• Overall survival (OS)

  36 months

• Adverse events

  36 months

Study Arms (2)

Thermal ablation

EXPERIMENTAL

Patients only accepted thermal ablation (microwave ablation,radiofrequency ablation)

Procedure: Thermal ablation

Microwave ablation plus Donafenib

EXPERIMENTAL

Patients accepted thermal ablation (microwave ablation,radiofrequency ablation) plus Donafenib (100mg, bid)

Procedure: Thermal ablation; Drug: Donafenib

Interventions

Thermal ablation PROCEDURE

Thermal ablation of tumors

Microwave ablation plus Donafenib; Thermal ablation

Donafenib DRUG

Donafenib ( 100 mg，bid)

Microwave ablation plus Donafenib

Eligibility Criteria

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

You may qualify if:

• were aged 18-75 years;
• had recurrent HCC (RHCC) diagnosed by imaging studies, the first or the second RHCC;
• RHCC met the Milan criteria, namely single RHCC lesion less than 5 cm in diameter or no more than 3 tumors (each ≤3 cm in diameter);
• the early RHCC (recurrent time \<1 year)
• patients were unwilling to undergo repeat hepatectomy or liver transplantation;
• had well-preserved liver function, i.e., Child-Pugh class A or B, and prolonged prothrombin time≤5 s;
• patients had an Eastern Cooperative Oncology Group performance status score ≤1.
• Ability to understand the protocol and to agree to and sign a written informed consent document.

You may not qualify if:

• were under 18 years or over 75 years of age;
• primary HCC;
• recurrent HCC beyond Milan criteria;
• RHCC with metastasis or macrovascular tumor thrombus

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Chinese PLA General Hospital: collaborator

Study Sites (1)

Chinese PLA General hospital

Beijing, None Selected, 100853, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Interventions

Transurethral Resection of Prostate; donafenib

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Feng Duan, Professor

  Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Qunfang Zhou, MD

CONTACT

86 19868000115; zhouqun988509@163.com

Feng Duan, Professor

CONTACT

86 13910984586; duanfeng@vip.sina.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: Clinical Professor

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: December 3, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)