NCT05022628

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 Translated with www.DeepL.com/Translator (free version)

Detailed description

In the pre-enrollment screening phase, investigators are required to record all screened patients uniformly on a subject screening and enrollment form that focuses on basic patient information (name, date of birth, and gender), date of screening received, and outcome (e.g., included in the study, not included in the study, and their reasons). The screening items in this phase are all part of the routine clinical treatment process, and the results of the tests performed before the patient signs the informed consent form can be used for evaluation. Patients who subsequently meet all inclusion and exclusion criteria are required to sign the informed consent form before they can be enrolled in the trial. Patients with hepatocellular carcinoma who meet the inclusion criteria are fully evaluated during the screening phase to see if they meet the enrollment criteria. Complete the following items within 28 days prior to treatment initiation. * Obtain a written signed ICF. * Demographic information: including date of birth, gender, ethnicity/race. * History of alcohol consumption, history of smoking. * Past medical and treatment history: take all past medical and treatment histories other than this indication that began prior to signing the ICF and that are considered relevant to this study. * Physical examination: including head, eyes, ears, nose, throat, neck, heart, chest (including lungs), abdomen, extremities, skin, lymph nodes, nervous system, and general condition of the subject. * Height and weight measurements. * Vital signs: temperature, respiration, blood pressure and heart rate. * ECOG score: it is recommended that the ECOG evaluation be performed by the same investigator throughout the study period, as detailed in Appendix 4. * Child-Pugh score (Appendix 5). * CNLC staging and Barcelona liver cancer staging. * Virological testing: hepatitis B two-for-half \[including hepatitis B virus surface antibody (HBsAb), HBsAg, hepatitis B virus e antigen (HBeAg), hepatitis B virus e antibody (HBeAb), and HBcAb\], HCV antibody, and HIV antibody. * Review of inclusion and exclusion criteria to assess the eligibility of subjects for inclusion. * AE collection: for AEs after signing the ICF and before the first dose, they should be recorded on the past medical history page of the CRF. Complete the following items within 14 days prior to treatment initiation. * Routine blood tests including: red blood cell count, hemoglobin, red blood cell pressure, white blood cell count and classification (neutrophils, lymphocytes, eosinophils, monocytes, basophils), and platelet count; obtain baseline values within 14 days prior to enrollment. * Blood biochemical tests including: total protein, albumin, creatinine, ALP, lactate dehydrogenase, total bilirubin, direct bilirubin, AST, ALT, calcium, phosphorus, potassium, sodium, and chloride. * Routine urine examination including: specific gravity, pH, urine sugar, protein, tubular, ketone bodies, blood cells; 24-hour urine protein quantification is required if 2 consecutive urine protein tests are ++ or more or if the physician judges the results to be abnormal and clinically significant. * Fecal occult blood * Coagulation tests including: aPTT, PT, TT, INR * Blood pregnancy test: female subjects of childbearing age only. * 12-lead electrocardiogram (ECG). * alpha-fetoprotein (AFP). * HBV-DNA quantification: HBV-infected subjects only. * Tumor assessment: screening tumor assessment must be performed within 14 days prior to enrollment and should include a CT or MRI scan of the chest, abdomen, or pelvis; if clinically indicated, any other known or suspected disease site may be examined using appropriate methods, such as a cranial MRI, bone scan, or CT scan of the neck; imaging of tumors done for routine visits before the subject signs up for ICF need not be repeated if done within 3 weeks prior to enrollment and at this study center; baseline and follow-up assessments should be performed using the same imaging methods and assessed by the same investigator whenever possible. * Combined medication/combined treatment collection: all medication received by the subject from 14 days prior to enrollment must be recorded in the CRF, including the generic name and daily dose of the medication, the reason for the use of that medication, the start date and the end date. * Assign enrollment number. Translated with www.DeepL.com/Translator (free version)

Conditions

• HCC
• Chemotherapy Effect

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-30
• Primary completion: 2023-08-01
• Completion: 2024-08-01
• First posted: 2021-08-26
• Last updated: 2021-09-21

Regulatory

• FDA-regulated drug study