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AzTrials

Hepatocellular CarcinomaPhase 1NCT05225116

Safety and Efficacy of Lenvatinib and Anti-PD1 Antibody Combined With Radiotherapy Neoadjuvant Treatment for Resectable Hepatocellular Carcinoma With PVTT

A Phase 1 study testing Sintilimab, Lenvatinib and radiotherapy in people with Hepatocellular Carcinoma, run by Beijing Tsinghua Chang Gung 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

Patients with hepatocellular carcinoma with PVTT can benefit from surgical resection and radiotherapy. As the rapid development of systematic treatment in hepatocellular carcinoma, ICIs neoadjuvant therapy is being actively explored .But there is no evidence to prove the safety and efficacy of lenvatinib and anti-PD1… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Sintilimab, Lenvatinib and radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
8 Jan 2023to 5 Dec 2025
Phase
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18-70, with no gender limitation;
  • HCC patients who strictly met the clinical diagnostic criteria of The Code for The Diagnosis and Treatment of Primary Liver Cancer (2019 edition) or were confirmed by histopathological or cytological examination;
  • BCLC stage C, no distant metastasis;
  • Patients with PVTT of type VP1-2-3-4 according to Japanese VP Classification;
  • The primary tumor can be resected (the remaining liver has complete vascular structure and sufficient liver volume, in line with the decision-making system of safe liver resection)
  • ECOG score 0-1;
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  • Child-Pugh score ≤7;
  • If the patient is HBV antigen positive, HBV DNA < 500 IU/ mL, conventional antiviral treatment;
  • The major organs meeting the following criteria:
  • Adequate bone marrow function, defined as: Absolute neutrophil count (ANC ≥ or equal to 1.5 X 10 ^ 9 per liter (/ L)) Hemoglobin (Hb ≥ 8.5 g/dL) Platelet count ≥ 75×10 ^ 9 / L.
  • Adequate liver function, defined as: Albumin > 2.8 g/dL Bilirubin is 3.0 mg/dL or less Aspartate aminotransferase (AST), alkaline phosphatase (ALP) and alanine aminotransferase (ALT) are less than or equal to 5 ULN.
  • Adequate coagulation function, defined as an international standardized ratio ( (INR) of 2.3 or less.
  • Adequate renal function was defined as creatinine clearance greater than 40 mL/min (mL/min), calculated according to the Cockcroft and Gault formulas.
  • Adequate pancreatic function, defined as amylase and lipase. = 1.5 x ULN.
  • Adequate control of blood pressure (BP) with up to 3 antihypertensive drugs, defined as BP-lt at screening time; = 150/90 mmHg (mmHg), and there was no change in antihypertensive therapy 1 week prior to cycle 1 / day 1.
  • Patients are expected to survive longer than 3 months.
  • No pregnancy or pregnancy plan.
  • Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up.

Who cannot join

  • Extrahepatic metastasis of primary hepatocellular carcinoma;
  • Diffuse liver cancer;
  • Patients who had previously received targeted drugs or immune checkpoint inhibitors;
  • allergic to Lenvatinib or PD-1 inhibitor ingredients;
  • Patients with grade II or higher myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (including QTc interval ≥470 ms); Patients with grade III ~ IV cardiac insufficiency according to NYHA standard, or left ventricular ejection fraction (LVEF) < 50% as indicated by color doppler echocardiography;
  • abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT \&gt; 1.5ULN), with bleeding tendency or receiving thrombolytic or anticoagulant therapy;
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  • pregnant or breast-feeding women; Fertile patients unwilling or unable to take effective contraceptive measures;
  • have a history of mental illness or abuse of psychotropic drugs;
  • patients with co-HIV infection;
  • a history of liver resection, liver transplantation, interventional therapy, and other malignant tumors;
  • patients with active infection;
  • contraindications to radiotherapy;
  • Patients with poor compliance such as floating population;
  • participants in clinical trials of other experimental drugs or devices within 4 weeks;
  • those considered unsuitable for inclusion by the researcher.

Trial locations and contacts

1 site in 1 country.

Jiahong Dong, MD contact

17346539401

ysza02008@btch.edu.cn

ShiZhong Yang contact

17346539401

ysza02008@btch.edu.cn

China1 site, 1 recruiting

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality, 102218

    ShiZhong Yang, 17346539401, ysza02008@btch.edu.cn

    Guangxin Li, 15810890312, lgxa02385@btch.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Safety and Efficacy of Lenvatinib and Anti-PD1 Antibody Combined With Radiotherapy Neoadjuvant Treatment for Resectable Hepatocellular Carcinoma With PVTT,Prospective, Multicenter, Single-arm Study

Patients with hepatocellular carcinoma with PVTT can benefit from surgical resection and radiotherapy. As the rapid development of systematic treatment in hepatocellular carcinoma, ICIs neoadjuvant therapy is being actively explored .But there is no evidence to prove the safety and efficacy of lenvatinib and anti-PD1 antibody combined with radiotherapy neoadjuvant treatment for resectable hepatocellular carcinoma with PVTT. This study intends to supplement the evidence of benefit in such patients.

Being tested
Sintilimab, Lenvatinib, radiotherapy
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • SintilimabDrug

    Sintilimab will be at a dose of 200mg,Q3W

  • LenvatinibDrug

    On the first day of the trial, Lenvatinib will be taken orally once daily （8mg/day ≤ 60kg or 12mg/day ≥60kg).

  • radiotherapyRadiation

    Radiotherapy will be completed within two weeks at a dose of 300cGy× 10 fraction

Study groups in NCT05225116
Study groupRoleWhat they receive
Sintilimab+Lenvatinib+RadiotherapyExperimentalNot described
Receives: Drug: Sintilimab; Drug: Lenvatinib; Radiation: radiotherapy

What is being measured

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

  1. Safety(CTCAE v5.0)

    Number of patients who reported incidence of grade ≥3 treatment related adverse events.

    Measured: up to 5 years

  2. Number of patients who complete pre-op treatment and proceed to surgery

    Number of patients who complete pre-op treatment and proceed to surgery

    Measured: up to 5 years

Secondary outcomes (6)

  1. Major Pathological Response(MPR)

    Survival tumor ≤10% during surgery

    Measured: Within 3 months after surgery

  2. Objective Response Rate(ORR)

    Efficacy included objective response (includes complete and partial response) according to modified RECIST 1.1 for HCC

    Measured: within 1 week before surgery

  3. Imaging-pathology Concordance Rate

    Imaging-pathology Concordance Rate

    Measured: Within 3 months after surgery

  4. PVTT regression rate

    The fading rate of PVTT

    Measured: Within 3 months after surgery

  5. Median Overall survival(mOS)

    mOS is defined as the median difference (in months) between the date of study enrollment to the date death due to any cause

    Measured: up to 5 years

  6. Recurrence free survival(RFS)

    From radical resection to the date of the first documented tumor into recurrence or death from any cause, whichever occurred first

    Measured: 1 year after surgery

Timeline

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

  1. First posted4 Feb 2022
  2. Study start8 Jan 2023
  3. Primary completion5 Dec 2025 (estimated)
  4. Study completion5 Dec 2025 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05225116
Sponsor's protocol ID
21323-0-03
Status last verified
Jan 2023
First submitted
23 Jan 2022
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li G, Shu B, Zheng Z, Yin H, Zhang C, Xiao Y, Yang Y, Yan Z, Zhang X, Yang S, Li G, Dong J. Safety and efficacy of radiotherapy combined with lenvatinib plus PD-1 inhibitors as neo-adjuvant therapy in hepatocellular carcinoma with portal vein thrombus: protocol of an open-label, single-arm, prospective, multi-center phase I trial. Front Oncol. 2022 Nov 24;12:1051916. doi: 10.3389/fonc.2022.1051916. eCollection 2022.

    PubMed 36505833

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sintilimab, Lenvatinib and radiotherapy in people with Hepatocellular Carcinoma, run by Beijing Tsinghua Chang Gung 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 18 inclusion and 15 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 8 Feb 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Jiahong Dong, MD (17346539401, ysza02008@btch.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety(CTCAE v5.0) (time frame: up to 5 years). The study lists 2 primary outcomes in all. 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 NCT05225116, which also lists 1 linked publication.

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 8 Feb 2023.

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