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Hepatocellular CarcinomaPhase 2NCT05161143

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

A Phase 2 study testing Donafenib in people with Hepatocellular Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Donafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Dec 2021to Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 ~ 75 years old (including boundary value), male and female;
  • Radical resection of liver cancer and intraoperative ablation of tumors ≤ 2cm were performed 4 ~ 8 weeks before enrollment;
  • Hepatocellular carcinoma diagnosed by pathology and meeting at least one of the following conditions:
  • Single tumor with tumor size ≥ 5cm;
  • Pathology showed microvascular invasion (MVI);
  • Satellite foci were found in the specimens;
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  • Multiple lesions (≥ 3);
  • AFP ≥ 400 ng / ml one week before operation
  • Preoperative imaging and / or intraoperative or postoperative pathological reports found PVTT type I: tumor thrombus invaded the secondary and above branches of portal vein;
  • No anti-tumor treatment was received before operation;
  • Liver function grade child Pugh a;
  • Physical condition (PS) score of Eastern cancer cooperation group (ECoG) was 0-1;
  • Imaging examination ≥ 4 weeks after operation confirmed that there was no recurrence and metastasis;
  • The estimated survival time shall not be less than 3 months;
  • With sufficient organ function reserve, the laboratory test values within 14 days before treatment must meet the following standards:
  • Blood routine examination: Hb≥100 g/L; ANC≥1.5 × 109 /L; PLT≥75 × 109 /L
  • Biochemical examination: ALB ≥28g/L; ALT and AST < 5 × ULN; TBIL ≤2 × ULN; creatinine ≤ 1.5 × ULN or creatinine clearance (CCR) ≥ 50 ml / min
  • The electrolyte is basically normal or normal after treatment;
  • 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);
  • Coagulation function:
  • international standard ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN activated partial coagulation time (APTT) ≤ 1.5 × ULN
  • 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;
  • The patients were enrolled voluntarily, could provide written informed consent, and could understand and comply with the trial protocol to follow-up.

Who cannot join

  • The pathological diagnosis was fiberboard HCC, sarcomatoid HCC, hepatocellular carcinoma intrahepatic cholangiocarcinoma (HCC-ICC);
  • Positive margin or tumor rupture;
  • Reoperation of recurrent liver cancer;
  • Previous liver transplantation;
  • AFP did not return to normal at 4 weeks and did not return to normal at 6 weeks after operation;
  • 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;
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  • Received other adjuvant therapy (except antiviral therapy), including adjuvant local therapy;
  • 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;
  • 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.
  • Previous history of severe mental illness;
  • 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.);
  • 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;
  • The patient has known or suspected allergy to tyrosine kinase inhibitor (TKI) drugs, or is allergic to the excipients of the study drugs;
  • There are uncontrollable hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion or pericardial effusion;
  • Have active bleeding or abnormal coagulation function, have bleeding tendency or are receiving thrombolytic, anticoagulant or antiplatelet therapy;
  • 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);
  • Gastrointestinal perforation, abdominal fistula or abdominal abscess occurred in the past 6 months;
  • Thrombosis or thromboembolism events occurred in the past 6 months, such as stroke and / or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc;
  • Uncontrolled cardiovascular disease judged by the researcher. Including but not limited to the following situations:
  • acute myocardial infarction in the past 6 months;
  • Severe / unstable angina pectoris or coronary artery bypass grafting;
  • Congestive heart failure (NYHA > 2);
  • Arrhythmias with poor control or requiring pacemaker treatment;
  • Hypertension (systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg) ";
  • Active infection requiring treatment
  • 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;
  • Active hepatitis C (HCV-RNA ≥ 103 copies / ml) with abnormal liver function [ALT or ast > 3 × ULN with TBIL > 2 × ULN or clinical jaundice]);
  • pregnant or lactating women, and female or male patients with fertility are unwilling or unable to take effective contraceptive measures;

Trial locations and contacts

1 site in 1 country.

Haifeng XU, doctor contact

186 1043 1165

xuhf781120@sina.com

China1 site

  • Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

    Beijing

    Haifeng XU, Doctor, 18610431165, xuhf781120@sina.com

    Yilei Mao, MD

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Donafenib
Keywords
hepatocellular carcinoma, Adjuvant therapy, Donafenib
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DonafenibDrug

    Also called 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.

Study groups in NCT05161143
Study groupRoleWhat they receive
Experimental: Donafenib plus TACEExperimentalDonafenib: 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.
Receives: Drug: Donafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1 year RFS rate

    1 year relapse-free survival rate

    Measured: 1 year

Secondary outcomes (6)

  1. RFS

    Recurrence Free Survival

    Measured: 3 years

  2. OS

    Overall Survival

    Measured: 3 years

  3. TTR

    Time To Recurrence

    Measured: 3 years

  4. 2/3 year RFS rate

    2/3 year Recurrence free survival rate

    Measured: 2/3 years

  5. AE

    Adverse events

    Measured: 3 years

  6. AFP

    Alpha fetal protein

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2021
  2. Study startDec 2021 (estimated)
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05161143
Sponsor's protocol ID
SH3137
Status last verified
Nov 2021
First submitted
2 Dec 2021
Last updated
17 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74.

    PubMed 15761078

  • Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.

    PubMed 26808342

  • Lu SD, Li L, Liang XM, Chen W, Chen FL, Fan LL, Ahir BK, Zhang WG, Zhong JH. Updates and advancements in the management of hepatocellular carcinoma patients after hepatectomy. Expert Rev Gastroenterol Hepatol. 2019 Nov;13(11):1077-1088. doi: 10.1080/17474124.2019.1684898. Epub 2019 Oct 30.

    PubMed 31648568

  • Akateh C, Black SM, Conteh L, Miller ED, Noonan A, Elliott E, Pawlik TM, Tsung A, Cloyd JM. Neoadjuvant and adjuvant treatment strategies for hepatocellular carcinoma. World J Gastroenterol. 2019 Jul 28;25(28):3704-3721. doi: 10.3748/wjg.v25.i28.3704.

    PubMed 31391767

  • Cucchetti A, Piscaglia F, Caturelli E, Benvegnu L, Vivarelli M, Ercolani G, Cescon M, Ravaioli M, Grazi GL, Bolondi L, Pinna AD. Comparison of recurrence of hepatocellular carcinoma after resection in patients with cirrhosis to its occurrence in a surveilled cirrhotic population. Ann Surg Oncol. 2009 Feb;16(2):413-22. doi: 10.1245/s10434-008-0232-4. Epub 2008 Nov 26.

    PubMed 19034578

  • European Association For The Study Of The Liver; European Organisation For Research And Treatment Of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2012 Apr;56(4):908-43. doi: 10.1016/j.jhep.2011.12.001. No abstract available.

    PubMed 22424438

  • Shen A, Liu M, Zheng D, Chen Q, Wu Z. Adjuvant transarterial chemoembolization after curative hepatectomy for hepatocellular carcinoma with microvascular invasion: A systematic review and meta-analysis. Clin Res Hepatol Gastroenterol. 2020 Apr;44(2):142-154. doi: 10.1016/j.clinre.2019.06.012. Epub 2019 Jul 11.

    PubMed 31303533

  • Ye JZ, Chen JZ, Li ZH, Bai T, Chen J, Zhu SL, Li LQ, Wu FX. Efficacy of postoperative adjuvant transcatheter arterial chemoembolization in hepatocellular carcinoma patients with microvascular invasion. World J Gastroenterol. 2017 Nov 7;23(41):7415-7424. doi: 10.3748/wjg.v23.i41.7415.

    PubMed 29151695

  • Wong JS, Wong GL, Tsoi KK, Wong VW, Cheung SY, Chong CN, Wong J, Lee KF, Lai PB, Chan HL. Meta-analysis: the efficacy of anti-viral therapy in prevention of recurrence after curative treatment of chronic hepatitis B-related hepatocellular carcinoma. Aliment Pharmacol Ther. 2011 May;33(10):1104-12. doi: 10.1111/j.1365-2036.2011.04634.x. Epub 2011 Mar 24.

    PubMed 21488914

  • Wu J, Yin Z, Cao L, Xu X, Yan T, Liu C, Li D. Adjuvant pegylated interferon therapy improves the survival outcomes in patients with hepatitis-related hepatocellular carcinoma after curative treatment: A meta-analysis. Medicine (Baltimore). 2018 Jul;97(28):e11295. doi: 10.1097/MD.0000000000011295.

    PubMed 29995763

  • Wang Z, Ren Z, Chen Y, Hu J, Yang G, Yu L, Yang X, Huang A, Zhang X, Zhou S, Sun H, Wang Y, Ge N, Xu X, Tang Z, Lau W, Fan J, Wang J, Zhou J. Adjuvant Transarterial Chemoembolization for HBV-Related Hepatocellular Carcinoma After Resection: A Randomized Controlled Study. Clin Cancer Res. 2018 May 1;24(9):2074-2081. doi: 10.1158/1078-0432.CCR-17-2899. Epub 2018 Feb 2.

    PubMed 29420221

  • Liu S, Guo L, Li H, Zhang B, Sun J, Zhou C, Zhou J, Fan J, Ye Q. Postoperative Adjuvant Trans-Arterial Chemoembolization for Patients with Hepatocellular Carcinoma and Portal Vein Tumor Thrombus. Ann Surg Oncol. 2018 Jul;25(7):2098-2104. doi: 10.1245/s10434-018-6438-1. Epub 2018 May 4.

    PubMed 29728879

  • Ono T, Yamanoi A, Nazmy El Assal O, Kohno H, Nagasue N. Adjuvant chemotherapy after resection of hepatocellular carcinoma causes deterioration of long-term prognosis in cirrhotic patients: metaanalysis of three randomized controlled trials. Cancer. 2001 Jun 15;91(12):2378-85.

    PubMed 11413528

  • Chen ZH, Zhang XP, Zhou TF, Wang K, Wang H, Chai ZT, Shi J, Guo WX, Cheng SQ. Adjuvant transarterial chemoembolization improves survival outcomes in hepatocellular carcinoma with microvascular invasion: A systematic review and meta-analysis. Eur J Surg Oncol. 2019 Nov;45(11):2188-2196. doi: 10.1016/j.ejso.2019.06.031. Epub 2019 Jun 25.

    PubMed 31256949

  • Wang L, Ke Q, Lin N, Zeng Y, Liu J. Does postoperative adjuvant transarterial chemoembolization benefit for all patients with hepatocellular carcinoma combined with microvascular invasion: a meta-analysis. Scand J Gastroenterol. 2019 May;54(5):528-537. doi: 10.1080/00365521.2019.1610794. Epub 2019 May 12.

    PubMed 31081401

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Donafenib in people with Hepatocellular Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Haifeng XU, doctor (186 1043 1165, xuhf781120@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1 year RFS rate (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05161143, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.

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