A Single Center Study of Donafenib Combined With PD-1 + TACE in the First-line Treatment of aHCC

NCT05262959 | Completed Phase 2

• 1 other identifier: B2021-631R
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is expected to recruit 30 patients with unresectable HCC who will be treated with Donafenib combined with PD-1 + TACE. During the study period, the tumor efficacy and resectability will be evaluated by imaging examination every 6 weeks. Patients with successful transformation can choose hepatectomy or observation. During the study, safety evaluation and effectiveness evaluation will be carried out.

Conditions

Donafenib

Keywords

Donafenib; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival 1(PFS 1)

  PFS 1 refers to the time from the date of enrollment to the first documented tumor progression as assessed by mRECIST criteria or death from any cause.

  an average of 1 year

Secondary Outcomes (4)

• Objective response rate (ORR) per mRECIST

  an average of 1 year

• Disease control rate (DCR) per mRECIST

  an average of 1 year

• Overall survival (OS)

  an average of 1.5 year

• Adverse events and serious adverse events.

  an average of 1.5 year.

Study Arms (1)

Donafenib

EXPERIMENTAL

Donafenib: 0.1g po. BID. And it will be taken on the first day of the study. PD-1: 200mg ivgtt. Q3W. It will be used at the same time as Donafenib. TACE: The first treatment will be carried out 2-3 weeks after taking Donafenib.

Drug: Donafenib, PD-1; Procedure: TACE

Interventions

Donafenib, PD-1 DRUG

Eligible subjects will receive Donafenib combined with PD-1 and TACE. Donafenib will be taken orally twice a day, 0.1mg each time.PD-1 will be used intravenously every 3 weeks.

Donafenib

TACE PROCEDURE

TACE will be performed by the investigator based on the patient's tumor status.

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:

• Patients voluntarily enter the study and sign informed consent form (ICF);
• Age ≥ 18 years and ≤ 75 years, and there is no limit on the gender;
• Clinically or histologically diagnosed as unresectable HCC;
• There is at least one measurable lesions that meet the mRECIST standard;
• Child-pugh classification A or B (score≤7);
• ECOG : 0 \~ 1 ;
• The number of intrahepatic tumors ≤ 10 and the maximum tumor diameter ≤ 10cm;
• Previous TACE treatment ≤ 1 time;
• Life expectancy ≥ 3 months;
• For patients with HBV infection, if HBV-DNA is≥10\^4copies/ml within 14 days before enrollment, they should take antiviral treatment first, reduce 1 log or reduce to \<10\^4copies/ml before entering the study, and continue antiviral treatment and monitor liver function and serum HBV-DNA levels;
• Baseline blood routine and biochemical indexes meet the following criteria within 14 days before treatment:
• Blood routine examination criteria must be met: (no blood transfusion within 14 days)
• HB≥90g/L；
• ANC≥1.5×10\^9/L；
• PLT≥70×10\^9/L.

You may not qualify if:

• Pathologically confirmed hepatocellular carcinoma intrahepatic cholangiocarcinoma (HCC-ICC) mixed or fibrolamellar hepatocellular carcinoma;
• The presence of a tumor thrombus in the main portal vein, biliary tract tumor thrombus, inferior vena cava tumor thrombus, or extrahepatic metastasis;
• Hepatocellular carcinoma recurrence within 2 years after radical resection or ablation;
• History of malignancy other than HCC within 5 years;
• Esophageal and/or gastric varices bleeding within 4 weeks prior to initiation of study treatment;
• Presence of uncontrolled hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion, or pericardial effusion;
• Patients who received liver transplant surgery, prior systemic therapy (chemotherapy, targeted therapy or immunotherapy) or palliative local treatment ≥2 times for HCC；
• History of organ and cell transplantation；
• TACE contraindications identified by the investigator;
• Active severe infection;
• Autoimmune disease or immune deficiency;
• Severe organ (heart, kidney) dysfunction;
• Pregnant or breastfeeding women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures;
• Unable to follow the research protocol for treatment or scheduled follow-up; Any other researcher who thinks they cannot be included.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University,

Shanghai, Shanghai Municipality, 200032, China

Location

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

• Jian Zhou, M.D., Ph.D.

  Zhongshan Hospital, Fudan University, Shanghai, China.

  PRINCIPAL INVESTIGATOR

• Zhiping Yan, M.D., Ph.D.

  Zhongshan Hospital, Fudan University, Shanghai, China.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: March 2, 2022
• Study Start: December 1, 2021
• Primary Completion: April 30, 2024
• Study Completion: May 30, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)