Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma

NCT06581315 | Recruiting

• 1 other identifier: SYXKY-2024-666-02
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy and safety of donafenib as adjuvant therapy for postoperative patients with high-risk recurrent Hepatocellular Carcinoma. This is a multicenter, randomized controlled study.

Conditions

Hepatocellular Carcinoma; Adjuvant Therapy

Keywords

Hepatocellular Carcinoma; Adjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• One year recurrence-free survival (RFS) rate

  The proportion from randomization to 1 year without recurrence.

  1 year

Secondary Outcomes (3)

• Recurrence-Free Survival (RFS )

  6 years

• Recurrence-Free Survival rate (RFS rate)

  5 years

• Overall Survival (OS)

  6 years

Study Arms (2)

Arm A (Donafenib)

EXPERIMENTAL

Participants will receive Donafenib treatment until disease recurrence or unacceptable toxicity or up to 1 years.

Drug: Donafenib

Arm B (active surveillance)

NO INTERVENTION

Active surveillance of participants.

Interventions

Donafenib DRUG

Donafenib 100 mg twice daily (BID)

Also known as: Zepsun

Arm A (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:

• Participants underwent radical resection of hepatocellular carcinoma 4 weeks before randomization
• High Risk of recurrence as assessed by tumor characteristics
• Without any anti-tumor therapy before surgery, except preoperative TACE therapy, traditional Chinese medicine therapy and interferon therapy
• Child-Pugh Class A statu
• ECOG Performance Status of 0 or 1
• CT/MR confirmed no recurrence or metastasis at ≥4 weeks after surgery
• Expected survival time of no less than 3 months

You may not qualify if:

• Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
• Evidence of residual or a history of spontaneous tumor rupture
• Recurrent HCC
• Prior received Liver transplantation
• Prior anti tumor therapy for treatment of HCC (including sorafenib or any other molecular therapy, anti-PD-1 antibody and other immunotherapies, FOLFOX systemic chemotherapy) is excluded
• AFP does not return to normal 4 weeks after operation

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

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

Study Officials

• Changzhen Shang, MD

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changzhen Shang, MD

CONTACT

+86-20-3407 0701; shchzh2@mail.sysu.edu.cn

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: August 30, 2024
• First Posted: September 3, 2024
• Study Start: August 28, 2024
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2032
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)