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Donafenib Combine With Sintilimab and HAIC in Neoadjuvant of Resectable Hepatocellular Carcinoma

NCT06512467 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-07-22

No results posted yet for this study

Summary

The investigators design a phase IIB clinical study to explore the efficacy and safety of Donafenib combined with Sintilimab and HAIC in neoadjuvant of resectable Hepatocellular Carcinoma.

Conditions

Interventions

DRUG

Donafenib

200 mg BID,oral administration will start before the first HAIC treatment .

DRUG

Sintilimab

200 mg Q3W,Intravenous infusion will perform before HAIC treatment.

OTHER

HAIC

HAIC,Q3W. The total number of HAIC treatments was determined by the investigator based on patient needs. Dose: Oxaliplatin 85 mg / m2 for 2h, Calcium folinate 400 mg / m2 for 2h, 5-FU 400 mg / m2 for 10min, followed by 5-FU 1200 mg / m2 for 23 hours).

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-07-30
Primary Completion
2026-07-30
Completion
2026-12-31

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Entities

Diseases

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 NCT06512467 on ClinicalTrials.gov