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Clinical Study of Radiotherapy Combined With Donafenib for Neoadjuvant Treatment of Patients With HCC With Portal Vein Carcinoma Thrombosis

NCT05022628 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-09-21

No results posted yet for this study

Summary

For HCC patients with combined PVTT, systemic therapy can be used as a basic approach throughout the treatment and in combination with hepatectomy, TACE, HAIC, radiotherapy, etc.

Our center proposes to conduct a clinical study of radiotherapy combined with donafinil for neoadjuvant treatment of HCC patients with portal vein carcinoma thrombosis to observe the safety and efficacy of donafinib combined with radiotherapy for neoadjuvant treatment

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Conditions

  • HCC
  • Chemotherapy Effect

Interventions

DRUG

Donafenib

Donafenib treatment regimen. 1. Donafenib started on the day of the first radiation treatment. 2. starting dose 0.2 g bid twice daily orally on an empty stomach (1 hour before or 2 hours after a meal). 3. Surgery after at least 1 week off Donafinil; resume Donafinil dosing as soon as possible after postoperative wound healing until any of the following occurs, whichever occurs first: (i) the subject develops an intolerable toxic reaction that does not resolve after dose adjustment (see 5.3 for details); (ii) 12 months of postoperative dosing; (iii) the subject has the first imaging-confirmed recurrence of disease or withdraws from the study (whichever occurs first). 4. Dose adjustment/withdrawal: Subjects are allowed up to 2 dose adjustments if they experience an adverse event related to the trial drug during treatment.

Sponsors & Collaborators

  • Anhui Provincial Hospital

    lead OTHER_GOV

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
2021-09-30
Primary Completion
2023-08-31
Completion
2024-08-31
FDA Drug
Yes

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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 NCT05022628 on ClinicalTrials.gov