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Hepatocellular CarcinomaEarly Phase 1NCT04974281

PD-1 Antibody and Lenvatinib Plus TACE on Downstaging BCLC B/C HCC

A Early Phase 1 study testing PD-1 and Lenvatinib Plus TACE in people with Hepatocellular Carcinoma, run by Fudan University 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

The purpose of this study is to assess the difference of safety and efficacy about PD-1 Antibody and Lenvatinib Plus transcatheter arterial chemoembolization (TACE) on downstaging hepatocellular carcinoma with BCLC B/C. 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?
PD-1 and Lenvatinib Plus TACE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
1 Jan 2021to 31 Dec 2022
Phase
Early Phase 1
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 years old and ≤75 years old;
  • Clinically diagnosed as hepatocellular carcinoma, stage B/C of BCLC;
  • No history of severe arrhythmia or heart failure;
  • No history of severe ventilation dysfunction or severe pulmonary infection;
  • No acute or chronic renal failure, the creatinine clearance rate was >40 mL/min;
  • Liver function Child A;
Show all 13Show fewer
  • Blood routine: absolute neutrophils count ≥1.5×10^9/L, Hb≥8.5g/L, PLT≥75×10^9/L;
  • Coagulation function: INR≤2.3;
  • ECOG score <2;
  • No local or systemic treatment, such as TACE, RFA, targeted drugs, traditional Chinese medicine, etc., before enrollment;
  • Expected survival ≥12 weeks;
  • At least one lesion can be measured and evaluated by CT/MRI according to RECIST 1.1 criteria;
  • Understand and sign the informed consent.

Who cannot join

  • Pregnant or lactating women;
  • Patients with other malignant tumors;
  • patients with complicated mental illness;
  • patients who have participated in other clinical trials in the last three months;
  • known or suspected allergy to any drug related to the study;
  • Patients with positive immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
Show all 11Show fewer
  • Patients treated with other targeted drugs, PD-L1 antibody and other immunotherapy or FOLFOX systemic chemotherapy after inclusion;
  • Patients with ≥1 + proteinuria indicated by urine routine will receive 24-hour urine protein detection, and patients with ≥1g 24-hour urine protein will not be included in the group.
  • Active autoimmune diseases that require systemic treatment (use of disease-alleviating agents, such as corticosteroids or immunosuppressants)
  • Patients with uncontrolled hepatitis B/C infection
  • Other conditions that the researcher considers not suitable for inclusion in this study

Trial locations and contacts

1 site in 1 country.

Lunxiu Qin, M.D contact

+862152887172

qinlx99@163.com

China1 site, 1 recruiting

  • Huashan hospital

    Shanghai, Shanghai Municipality, 200040

    Ying Zhu, Ph.D, +862152887175, yzhu14@fudan.edu.cn

    Lu Lu, M.D, +862152887174, lulu@huashan.org.cn

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of PD-1 Antibody and Lenvatinib Plus TACE on Downstaging Hepatocellular Carcinoma With BCLC B/C

The purpose of this study is to assess the difference of safety and efficacy about PD-1 Antibody and Lenvatinib Plus transcatheter arterial chemoembolization (TACE) on downstaging hepatocellular carcinoma with BCLC B/C.

Being tested
PD-1 and Lenvatinib Plus TACE
Keywords
Lenvatinib, PD-1, TACE, Downstaging
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • PD-1 and Lenvatinib Plus TACECombination product

    PD-1 Antibody and Lenvatinib Plus Transarterial chemoembolization(TACE )： Patients were recommended to receive TACE once every 6 weeks. Patients were recommended to begin oral administration of Lenvatinib 3 days after the first TACE treatment, and meanwhile to start intravenous drip of PD-1 antibody 3 days after the first TACE treatment, once every 3 weeks.

Study groups in NCT04974281
Study groupRoleWhat they receive
PD-1+TACE+LenOtherPD-1 Antibody and Lenvatinib Plus TACE
Receives: Combination Product: PD-1 and Lenvatinib Plus TACE

What is being measured

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

  1. Resection rate

    Resction rate refers to the proportion of patients who can receive radical surgery after downstaging treatment.

    Measured: 6 months after downstaging treatment

Secondary outcomes (4)

  1. Adverse events (safety)

    Postoperative adverse events (safety ) will be evaluated according to the NCI CTCAE Version 4.03.The number and severity of treatment-related side effects, including AE and SAE, will be recorded during treatment.

    Measured: 6 months

  2. Overall survival (OS)

    The duration from the date of recruitment to the date of death from any cause.

    Measured: 2 years

  3. Objective response rate (ORR)

    ORR is defined as the percentage of participants who have a confirmed complete response or partial response according to RECIST 1.1 or mRECIST.

    Measured: 6 months

  4. Progression free survival (PFS)

    PFS is defined as the time from enrollment of the trial to the first documented disease progression or death due to any cause.

    Measured: 6 months

Timeline

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

  1. First posted23 Jul 2021
  2. Study start1 Jan 2021
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04974281
Sponsor's protocol ID
HUASHAN007
Status last verified
Aug 2022
First submitted
20 Jun 2021
Last updated
18 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

  • Lencioni R, de Baere T, Soulen MC, Rilling WS, Geschwind JF. Lipiodol transarterial chemoembolization for hepatocellular carcinoma: A systematic review of efficacy and safety data. Hepatology. 2016 Jul;64(1):106-16. doi: 10.1002/hep.28453. Epub 2016 Mar 7.

    PubMed 26765068

  • Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, Baron A, Park JW, Han G, Jassem J, Blanc JF, Vogel A, Komov D, Evans TRJ, Lopez C, Dutcus C, Guo M, Saito K, Kraljevic S, Tamai T, Ren M, Cheng AL. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163-1173. doi: 10.1016/S0140-6736(18)30207-1.

    PubMed 29433850

  • Kato Y, Tabata K, Kimura T, Yachie-Kinoshita A, Ozawa Y, Yamada K, Ito J, Tachino S, Hori Y, Matsuki M, Matsuoka Y, Ghosh S, Kitano H, Nomoto K, Matsui J, Funahashi Y. Lenvatinib plus anti-PD-1 antibody combination treatment activates CD8+ T cells through reduction of tumor-associated macrophage and activation of the interferon pathway. PLoS One. 2019 Feb 27;14(2):e0212513. doi: 10.1371/journal.pone.0212513. eCollection 2019.

    PubMed 30811474

  • Kudo M, Ueshima K, Ikeda M, Torimura T, Tanabe N, Aikata H, Izumi N, Yamasaki T, Nojiri S, Hino K, Tsumura H, Kuzuya T, Isoda N, Yasui K, Aino H, Ido A, Kawabe N, Nakao K, Wada Y, Yokosuka O, Yoshimura K, Okusaka T, Furuse J, Kokudo N, Okita K, Johnson PJ, Arai Y; TACTICS study group. Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial. Gut. 2020 Aug;69(8):1492-1501. doi: 10.1136/gutjnl-2019-318934. Epub 2019 Dec 4.

    PubMed 31801872

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing PD-1 and Lenvatinib Plus TACE in people with Hepatocellular Carcinoma, run by Fudan University 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 13 inclusion and 11 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 18 Aug 2022. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 Lunxiu Qin, M.D (+862152887172, qinlx99@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resection rate (time frame: 6 months after downstaging treatment). 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 NCT04974281, which also lists 5 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 18 Aug 2022.

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