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HAIC Combined With Donafenib Tosilate and Toripalimab for Unresectable HCC

NCT05493332 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2022-08-18

No results posted yet for this study

Summary

This is a prospective, single-armed, multicentric, explorative phase II clinical research of conversional therapy with combination of hepatic arterial infusion chemotherapy(HAIC), Donafenib Tosilate and Toripalimab for unresectable hepatocellular carcinoma.

Conditions

Interventions

PROCEDURE

HAIC(FOLFOX)

After successful percutaneous hepatic artery cannulation, superior mesenteric arteriogram and hepatic arteriogram were performed, and after confirming that the subjects were eligible for enrollment according to the results, the hepatic artery was cannulated to the predetermined position. The catheter was connected to a syringe pump in the ward for continuous pumping of chemotherapy drugs.

DRUG

Oxaliplatin

85mg/m2 IVdrip from hour 0 to 2 on D1，Q3W

DRUG

Leucovorin

400mg/m2 IVdrip , from hour 0 to 2 on D1 to D2，Q3W

DRUG

Fluorouracil

400mg/m2 , bolus at hour 3 ; and 600mg/m2 IVdrip over 46 hours on D1 to D2，Q3W

DRUG

Toripalimab

240mg IVdrip，D3, Q3W

DRUG

Donafenib

0.1g. P.O, BID, continuously

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Zhiyu Xiao · Department of Hepatobiliary Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

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
2022-09-30
Primary Completion
2023-09-30
Completion
2024-09-30

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Drugs
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 NCT05493332 on ClinicalTrials.gov