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

NCT05022628 | Unknown Phase 4 FDA Drug

• 1 other identifier: ky153
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

HCC; Chemotherapy Effect

Outcome Measures

Primary Outcomes (1)

• Safety evaluation

  The incidence of adverse-effect and severe adverse-effect

  2 years

Study Arms (1)

Therapy arm

EXPERIMENTAL

donafenib

Drug: Donafenib

Interventions

Donafenib DRUG

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.

Also known as: Radiotherapy

Therapy arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 \~ 75 years (inclusive of cut-offs), male or female. Histologically confirmed HCC or meeting the AASLD guidelines for clinical diagnostic criteria for HCC.
• Patients with primary HCC without prior systemic therapy (except antiviral therapy) or local therapy and at least 1 measurable lesion meeting the definition of mRECIST criteria.
• Chinese primary liver cancer staging (CNLC) IIIa, Cheng's portal PVTT staging type II/III, tumor confined to a single liver lobe, tumor load \<50%.
• Liver function Child-Pugh score of 5-7. Eastern Cooperative Oncology Group (ECOG) physical status (PS) score 0-1. Expected survival of not less than 3 months. HBV-infected patients with HBV-DNA of ≥104copies/ml within 14 days prior to enrollment, followed by antiviral therapy (entecavir recommended) down to \<104copies/ml before study entry, and continued antiviral therapy and monitoring of liver function and serum HBV-DNA levels.
• Have adequate organ function reserve and laboratory test values within 14 days prior to treatment must meet the following criteria.
• Routine blood tests. Hb≥100 g/L ANC ≥ 1.5×109 /L PLT ≥ 75×109 /L Biochemical examination. ALB ≥28g/L ALT and AST \<5×ULN TBIL ≤1.5×ULN Creatinine ≤1.5×ULN or creatinine clearance (Ccr) ≥50 mL/min Creatinine clearance needs to be calculated by the Cockcroft-Gault formula. Men. Creatinine clearance = ((140 age) × body weight (kg))/(72 × serum creatinine (mg/dL)) Females: Male calculation × 0.85. Basic normal electrolytes or normal with treatment. Urine protein \<2+ or quantitative 24-hour urine protein test ≤1.0 g/L (for patients with urine protein ≥2+, quantitative 24-hour urine protein test must be ≤1.0 g/L to be enrolled).
• Coagulation function. International standard ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN Activated partial clotting time (aPTT) ≤ 1.5 x ULN Patients were voluntarily enrolled, able to provide written informed consent, and able to understand and comply with the trial protocol for medication administration and follow-up.

You may not qualify if:

• Pre-existing or co-morbidities.
• pathologically confirmed hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC) mixed or fibrous lamellar-like hepatocellular carcinoma.
• recurrent hepatocellular carcinoma.
• previous local treatment (including hepatectomy, liver transplantation, TACE, HAIC, radiotherapy, etc.) or systemic treatment (except antiviral therapy)
• multiple (number of nodules \>3) or diffuse intrahepatic nodules
• presence of inferior vena cava carcinoma thrombosis, hepatic vein carcinoma thrombosis or bile duct carcinoma thrombosis, extrahepatic metastases or tumor load \>50%.
• the presence of other malignancies within 5 years, unless the patient has received potentially curative treatment and there has been no evidence of the presence of that disease within 5 years, except that this time requirement (i.e., within 5 years) does not apply to patients with successfully resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or other carcinoma in situ
• A prior history of serious psychiatric illness.
• medical conditions affecting the absorption, distribution, metabolism or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.) Pre-existing or combined medication/treatment.
• Have undergone major surgery (as determined by the investigator) within 4 weeks prior to enrollment.
• Patients who have received other systemic antitumor therapy prior to enrollment, including other herbal medicines with antitumor indications, for less than 2 weeks or 5 drug half-lives (whichever is longer) after completion of treatment until dosing in this study, or who have not recovered to ≤ CTCAE grade 1 from adverse events caused by preoperative therapy.
• Concomitant administration of drugs that may prolong QTc and/or induce tip-twisting ventricular tachycardia (Tdp) or that affect drug metabolism.
• Safety.
• Patients with a known or suspected history of allergy to tyrosine kinase inhibitor (TKI) drugs or to excipients of the study drug.
• Presence of uncontrollable hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion or pericardial effusion.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

MeSH Terms

Interventions

donafenib; Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 26, 2021
• Study Start: September 30, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: September 21, 2021

Record last verified: 2021-09