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Donafenib Combined With TACE as Adjuvant Therapy of Patients With Hepatocellular Carcinoma

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05161143
Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd (Industry)
30
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators design a phase IIB clinical study to explore the efficacy and safety of Donafenib combined with TACE as adjuvant therapy of patients with hepatocellular carcinoma at a high risk of recurrence after radical resection.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This trial is a single-arm, non-randomized and single-center clinical study of targeted therapy combined TACE in patients with hepatocellular carcinoma at a high risk of recurrence after radical resection.It is estimated that 30 patients who met the study criteria will be enrolled in Peking Union Medical College Hospital(PUMCH) and treated with Donafenib and TACE. The investigators will follow up and collect subjects' data monthly to evaluate the efficacy and safety of treatment, including overall survival and time to progression.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Donafenib Combined With TACE as Adjuvant Therapy of Patients With Hepatocellular Carcinoma at a High Risk of Recurrence After Radical Resection
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental: Donafenib plus TACE

Donafenib: 4-8 weeks after radical surgery,patients will take donafenib, 200mg Bid,at least 6 months. TACE:4-8 weeks after radical surgery,Patients will receive TACE once.

Drug: Donafenib
Donafenib: 4-8 weeks after radical surgery,patients will take donafenib, 200mg Bid,at least 6 months. TACE:4-8 weeks after radical surgery,patients will receive TACE once.
Other Names:
  • TACE

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 1 year RFS rate [1 year]

      1 year relapse-free survival rate

    Secondary Outcome Measures

    1. RFS [3 years]

      Recurrence Free Survival

    2. OS [3 years]

      Overall Survival

    3. TTR [3 years]

      Time To Recurrence

    4. 2/3 year RFS rate [2/3 years]

      2/3 year Recurrence free survival rate

    5. AE [3 years]

      Adverse events

    6. AFP [3 years]

      Alpha fetal protein

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age 18 ~ 75 years old (including boundary value), male and female;

    2. Radical resection of liver cancer and intraoperative ablation of tumors ≤ 2cm were performed 4 ~ 8 weeks before enrollment;

    3. Hepatocellular carcinoma diagnosed by pathology and meeting at least one of the following conditions:

    4. Single tumor with tumor size ≥ 5cm;

    5. Pathology showed microvascular invasion (MVI);

    6. Satellite foci were found in the specimens;

    7. Multiple lesions (≥ 3);

    8. AFP ≥ 400 ng / ml one week before operation

    9. Preoperative imaging and / or intraoperative or postoperative pathological reports found PVTT type I: tumor thrombus invaded the secondary and above branches of portal vein;

    10. No anti-tumor treatment was received before operation;

    11. Liver function grade child Pugh a;

    12. Physical condition (PS) score of Eastern cancer cooperation group (ECoG) was 0-1;

    13. Imaging examination ≥ 4 weeks after operation confirmed that there was no recurrence and metastasis;

    14. The estimated survival time shall not be less than 3 months;

    15. With sufficient organ function reserve, the laboratory test values within 14 days before treatment must meet the following standards:

    16. Blood routine examination: Hb≥100 g/L; ANC≥1.5 × 109 /L; PLT≥75 × 109 /L

    17. Biochemical examination: ALB ≥28g/L; ALT and AST < 5 × ULN; TBIL ≤2 × ULN; creatinine ≤ 1.5 × ULN or creatinine clearance (CCR) ≥ 50 ml / min

    18. The electrolyte is basically normal or normal after treatment;

    19. Urinary protein < 2 + or 24-hour urinary protein quantitative test ≤ 1.0 g / L (for patients with urinary protein ≥ 2 +, 24-hour urinary protein quantitative test should be carried out, and they can be selected only when it is ≤ 1.0 g / L);

    20. Coagulation function:

    international standard ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN activated partial coagulation time (APTT) ≤ 1.5 × ULN

    1. Patients with HBsAg positive should continue antiviral treatment after operation and take first-line antiviral drugs such as entecavir or tenofovir or propofol tenofovir fumarate;

    2. The patients were enrolled voluntarily, could provide written informed consent, and could understand and comply with the trial protocol to follow-up.

    Exclusion Criteria:

    1. The pathological diagnosis was fiberboard HCC, sarcomatoid HCC, hepatocellular carcinoma intrahepatic cholangiocarcinoma (HCC-ICC);

    2. Positive margin or tumor rupture;

    3. Reoperation of recurrent liver cancer;

    4. Previous liver transplantation;

    5. AFP did not return to normal at 4 weeks and did not return to normal at 6 weeks after operation;

    6. Previously received systemic therapy for HCC, including targeted drug therapy such as Sorafenib, Lenvatinib and Regorafenib, or immunotherapy such as anti-PD-1, anti-PD-L1 and anti-CTLA-4, except antiviral therapy; If the patient has previously used traditional Chinese medicine with anti-tumor indications, it must be more than 4 weeks after the completion of treatment and before the medication in this study, and the adverse events caused by treatment have not recovered to ≤ CTCAE level 1;

    7. Received other adjuvant therapy (except antiviral therapy), including adjuvant local therapy;

    8. There were tumor thrombi in the main portal vein and primary branches, inferior vena cava, hepatic vein or bile duct, lymph node invasion or extrahepatic metastasis before operation;

    9. 5 years of suffering from other malignancies, unless the patient has received the possibility of curative treatment and there is no evidence of the disease within 5 years, the time requirement (i.e. 5 years) does not apply to successful basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ or other orthotopic cancer.

    10. Previous history of severe mental illness;

    11. Suffering from diseases affecting the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc.);

    12. Taking drugs that may prolong QTc and / or induce tip twist transition ventricular tachycardia (TDP) or drugs that affect drug metabolism at the same time;

    13. The patient has known or suspected allergy to tyrosine kinase inhibitor (TKI) drugs, or is allergic to the excipients of the study drugs;

    14. There are uncontrollable hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion or pericardial effusion;

    15. Have active bleeding or abnormal coagulation function, have bleeding tendency or are receiving thrombolytic, anticoagulant or antiplatelet therapy;

    16. Have a history of gastrointestinal hemorrhage or have a clear tendency of gastrointestinal bleeding in the past 4 weeks (e.g. local active ulcer lesions, fecal occult blood + + or more, gastroscopy should be performed if continuous fecal occult blood +, or other conditions that may cause gastrointestinal bleeding determined by the researcher (e.g. severe gastric fundus / esophageal varices);

    17. Gastrointestinal perforation, abdominal fistula or abdominal abscess occurred in the past 6 months;

    18. Thrombosis or thromboembolism events occurred in the past 6 months, such as stroke and / or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc;

    19. Uncontrolled cardiovascular disease judged by the researcher. Including but not limited to the following situations:

    20. acute myocardial infarction in the past 6 months;

    21. Severe / unstable angina pectoris or coronary artery bypass grafting;

    22. Congestive heart failure (NYHA > 2);

    23. Arrhythmias with poor control or requiring pacemaker treatment;

    24. Hypertension (systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg) ";

    25. Active infection requiring treatment

    26. Active hepatitis B (HBsAg positive and abnormal liver function): if the HBV-DNA is ≥ 104 copies / ml within 14 days before treatment, the patient shall first undergo antiviral treatment, reduce it to < 104 copies / ml, and then enter the study, continue antiviral treatment and monitor liver function and serum HBV-DNA level;

    27. Active hepatitis C (HCV-RNA ≥ 103 copies / ml) with abnormal liver function [ALT or ast > 3 × ULN with TBIL > 2 × ULN or clinical jaundice]);

    28. pregnant or lactating women, and female or male patients with fertility are unwilling or unable to take effective contraceptive measures;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chinese Academy of Medical Sciences & Peking Union Medical College Hospital Beijing China

    Sponsors and Collaborators

    • Peking Union Medical College Hospital
    • Suzhou Zelgen Biopharmaceuticals Co.,Ltd

    Investigators

    • Principal Investigator: Yilei Mao, MD, Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT05161143
    Other Study ID Numbers:
    • SH3137
    First Posted:
    Dec 17, 2021
    Last Update Posted:
    Dec 17, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Peking Union Medical College Hospital
    hepatocellular carcinoma
    Adjuvant therapy
    Donafenib
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of Dec 17, 2021