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

NCT05262959 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-13

No results posted yet for this study

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

Interventions

DRUG

Donafenib, PD-1

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.

PROCEDURE

TACE

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

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Jian Zhou, M.D., Ph.D. · Zhongshan Hospital, Fudan University, Shanghai, China.

  • Zhiping Yan, M.D., Ph.D. · Zhongshan Hospital, Fudan University, Shanghai, China.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2024-04-30
Completion
2024-05-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05262959 on ClinicalTrials.gov