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Advanced Hepatocellular CarcinomaPhase 2CISLD-12NCT05213221

Study on Therapeutic Effect of Combination of Envafolimab, Lenavatinib and TACE in Advanced HCC Patients

A Phase 2 study testing Envafolimab, TACE and Lenvatinib in people with Advanced Hepatocellular Carcinoma, run by Zhejiang University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a single-center, open, single-arm, phase II clinical trial. Eligible HCC patients, after signing informed consent, will receive TACE treatment. Envafolimab combined with Lenvatinib will be started on the day of TACE, and the subsequent TACE will be performed on demand. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Hepatocellular Carcinoma
What is being tested?
Envafolimab, TACE and Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteChina
Study dates
14 Mar 2022to 1 Jun 2023
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

  • Sign a written informed consent form prior to enrollment;
  • Age was 18-75 years old;
  • Hepatocellular carcinoma (HCC) was confirmed by imaging or histology or cytology;
  • Patients with stage C and B unresectable BCLC stage (either with portal cancer emboli including VP1-3, but not enrolled if the main portal cancer embolus completely blocked blood vessels and had no blood flow passage)
  • With measurable foci (non-lymph node lesion CT scan long diameter ≥ 10 mm, lymph node lesion CT scan short diameter ≥ 15 mm according to RECIST 1.1 criteria);
  • Has never previously received any antitumor system treatment, especially the immunotherapy;
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  • ECOG score: 0~1;
  • Child-Pugh score ≤ 7;
  • Have adequate organ function;
  • Estimated survival period of ≥ for 3 months;

Who cannot join

  • Previously diagnosed by histology/cytology with fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components.
  • The patient has suffered from other malignant tumors in the past or at the same time.
  • Patients who have received systemic anti-tumor therapy in the past;
  • For HCC lesions ≥10cm in any dimension, there are more than 10 lesions evaluated by imaging or HCC lesions account for ≥50% of the liver volume;
  • Is a current candidate for liver transplantation or has experienced liver transplantation;
  • There is a risk of bleeding, or coagulation dysfunction, or is undergoing thrombolytic therapy; or has had bleeding from esophageal or gastric varices in the past 6 months;
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  • Portal vein tumor thrombus Vp4.
  • The patient is known to have been allergic to macromolecular protein preparations or applied drug components;
  • The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis Patients with abnormal thyroid function (hyperthyroidism/decreased thyroid function), and the use of drugs cannot maintain thyroid function in the normal range, or previous thyroid surgery, patients who need long-term thyroxine and other drug replacement therapy after surgery; the patient has Vitiligo or asthma has been completely relieved in childhood, and those without any intervention after adulthood can be included; asthma whose patients require medical intervention with bronchodilators cannot be included)
  • The patient is using immunosuppressive agents, or systemic or absorbable local hormone therapy to achieve immunosuppressive purposes (dose>10mg/day prednisone or other curative hormones), and within 2 weeks before enrollment Still in use;
  • The patient is still using traditional Chinese medicine or other immunomodulators within 2 weeks before enrollment;
  • Ascites or pleural effusion with clinical symptoms cannot be controlled with drugs and requires therapeutic puncture or drainage;
  • There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) Heart failure above NYHA level 2 (2) Unstable angina (3) Myocardial infarction occurred within 1 year (4) Supraventricular with clinical significance Or patients with ventricular arrhythmia in need of treatment or intervention;
  • Severe infections that are active or poorly clinically controlled. Severe infections within 4 weeks before the first administration, including but not limited to hospitalization due to complications of infection, bacteremia or severe pneumonia, or fever of unexplained occurrence> 38.5 degrees during the screening period and before the first administration (by research According to the judge, the patient can be included in the group for fever caused by the tumor);
  • Past and current patients with objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc.; patients with known syphilis infection requiring treatment; active tuberculosis ( Active tuberculosis, TB), who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before the first administration.
  • patients with congenital or acquired immune deficiencies, such as HIV infection, or active hepatitis (transaminase does not meet the selection criteria, hepatitis B reference: HBV DNA ≥2000 IU/ml or ≥104 copies/ml; hepatitis C reference: HCV RNA≥2000 IU/ml or ≥104 copies/ml; after nucleotide antiviral therapy, it is lower than the above standard and can be included in the group); chronic hepatitis B virus carriers, HBV DNA<2000 IU/ml, test During this period, you must receive antiviral treatment at the same time before you can join the group;
  • Live vaccines may be vaccinated during the study period less than 4 weeks before the study medication;
  • The patient is known to have a history of psychotropic drug abuse, alcohol abuse or drug abuse;
  • The investigator believes that it should be excluded from the study. For example, the investigator judges that the patient has other factors that may cause the study to be terminated halfway, such as other serious diseases (including mental illness) that require combined treatment. Serious laboratory abnormalities, accompanied by family or social factors, can affect the safety of patients or the collection of data and samples.
  • The patient has metastases to the central nervous system.

Trial locations and contacts

1 site in 1 country.

China1 site

  • the First Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

Other trials in China

About this study

Official title: Study on Therapeutic Effect of Combination of Envafolimab, Lenavatinib and TACE in Advanced HCC Patients: an Open, Single Arm, Phase II Clinical Trial

This study is a single-center, open, single-arm, phase II clinical trial. Eligible HCC patients, after signing informed consent, will receive TACE treatment. Envafolimab combined with Lenvatinib will be started on the day of TACE, and the subsequent TACE will be performed on demand. Patients will receive the treatment continuously until disease progression or intolerance. Tumor imaging evaluation will be performed according to RECIST V1.1 criteria every 6 weeks. Safety will be assessed with CTCAE 5.0. Adverse events throughout and within 30 days of the end of the study will be recorded (severe adverse events or adverse events associated with Envafolimab will be recorded within 90 days after the end of treatment).Treatment will last for 2 years or until disease progression, withdrawal of informed consent, loss of visit, or death.

Being tested
Envafolimab, TACE, Lenvatinib

What participants receive

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

  • EnvafolimabDrug

    300mg, subcutaneous injection, q3w

  • TACEProcedure or surgery

    The first TACE will be started on d1, and the subsequent TACE will be performed on demand.

  • LenvatinibDrug

    8mg,QD (body weight <60kg); 12mg, QD (body weight ≥ 60kg)

Study groups in NCT05213221
Study groupRoleWhat they receive
Treatment groupExperimentalEnvafolimab, Lenvatinib and TACE
Receives: Drug: Envafolimab; Procedure: TACE; Drug: Lenvatinib

What is being measured

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

  1. Objective reponse rate (ORR)

    The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during study

    Measured: Up to 2 years.

Secondary outcomes (5)

  1. Disease control rate (DCR)

    The proportion of patients who had tumor evaluated as PR or SD according to RECIST1.1 criteria during study

    Measured: Up to 2 years.

  2. Duration of remission （DoR）

    The time from the first assessment of the tumor as CR or PR to the first assessment of PD or death from any cause.

    Measured: Up to 2 years.

  3. Progression-free survival （PFS）

    The time from enrolled to disease pregression or death from any cause.

    Measured: Up to 2 years.

  4. Overall survival (OS)

    The time from enrolled to death from any cause.

    Measured: Up to 2 years.

  5. Safety of treatment

    Safety evaluation was done continuously during treatment by using CTCAE 5.0

    Measured: Up to 2 years.

Timeline

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

  1. First posted28 Jan 2022
  2. Study start14 Mar 2022
  3. Primary completion1 Sep 2022
  4. Study completion1 Jun 2023

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
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05213221
Sponsor's protocol ID
CISLD-12
Acronym
CISLD-12
Status last verified
Jun 2023
First submitted
21 Dec 2021
Last updated
13 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen Y, Zhang J, Hu W, Li X, Sun K, Shen Y, Zhang M, Wu J, Gao S, Yu J, Que R, Zhang Y, Yang F, Xia W, Zhang A, Tang X, Bai X, Liang T. Envafolimab plus lenvatinib and transcatheter arterial chemoembolization for unresectable hepatocellular carcinoma: a prospective, single-arm, phase II study. Signal Transduct Target Ther. 2024 Oct 9;9(1):280. doi: 10.1038/s41392-024-01991-1.

    PubMed 39384742

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Envafolimab, TACE and Lenvatinib in people with Advanced Hepatocellular Carcinoma, run by Zhejiang 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 10 inclusion and 20 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: finished, as of the sponsor's last update on 13 Jun 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective reponse rate (ORR) (time frame: Up to 2 years.). 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 NCT05213221, 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 13 Jun 2023.

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