AzTrials
AzTrials

Advanced Hepatocellular CarcinomaPhase 1NCT06470256

Palliative Hepatectomy Combined With Targeted Therapy and Immunotherapy for Advanced Hepatocellular Carcinoma

A Phase 1 study testing Palliative Hepatectomy, Durvalumab and Lenvatinib in people with Advanced Hepatocellular Carcinoma, run by Zhiyong Huang at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Hepatocellular carcinoma (HCC) is one of the most common malignant tumors and the leading cause of cancer-related death worldwide. Surgical resection has always been the best hope for long-term survival of patients with HCC. 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?
Palliative Hepatectomy, Durvalumab and Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
1 Jun 2024to 1 Jun 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Patients aged 18 to 75 years (inclusive).
  • No prior systemic antitumor treatment or surgical treatment.
  • Clinical or pathological diagnosis of hepatocellular carcinoma (HCC).
  • The primary liver lesion is mainly isolated liver tumors, with a tumor burden exceeding 90% of the total tumor burden, and technically capable of complete resection. Simultaneously merging ① intrahepatic metastasis: the number of metastatic tumors is ≥ 3 and the sum of tumor diameters is ≤ 3cm; Or ② Extrahepatic metastasis: Extrahepatic metastasis does not exceed one organ, metastatic tumors do not exceed three, and the total diameter does not exceed 3cm. Or ③ if combined with portal vein tumor thrombus or hepatic vein tumor thrombus, it can be removed or completely removed together with the main tumor, and the tumor thrombus does not enter the superior mesenteric vein or inferior vena cava.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, without significant organ dysfunction.
  • Child-Pugh class A.
Show all 11Show fewer
  • HBV-DNA less than 1*10^5 copies/ml and undergoing antiviral therapy.
  • Important organ functions meeting the following criteria: White Blood Cell (WBC) ≥2.5 × 10^9/L ;Platelet (PLT) ≥75 × 10^9/L;Hemoglobin (HB) ≥ 9g/dL;Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 3*ULN, Total Bilirubin ≤ 3*ULN; International Normalized Ratio (INR) ≤ 1.5*ULN; Prothrombin Time ≤ 1.5*ULN; Creatinine ≤ 1.5*ULN.
  • Expected survival time of more than 3 months.
  • According to the RECIST v1.1 standard, postoperative patients with at least one longest diameter of 1 cm or more measurable tumors.
  • Willing to provide informed consent.

Who cannot join

  • History of or concurrent active malignancy (excluding malignancies that have been cured for over 5 years or in situ cancers that can be completely cured with adequate treatment).
  • Presence of central nervous system metastasis or a history of brain metastasis.
  • History of organ transplantation.
  • History of surgery in the head, chest, or abdomen within the past six months.
  • Child-Pugh class C liver function or massive ascites.
  • Ongoing active infection within 7 days after completion of systemic antibiotic therapy.
Show all 17Show fewer
  • Active coronary artery disease, severe/unstable angina, or newly diagnosed angina or myocardial infarction within the past 12 months before enrollment.
  • Thrombotic or embolic events within the past 12 months, such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, or deep vein thrombosis.
  • New York Heart Association (NYHA) class II or above congestive heart failure.
  • Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), positive syphilis serology, untreated active hepatitis (defined as HBV-DNA ≥ 10^5 copies/ml; HCV-RNA higher than the lower limit of detection for the assay).
  • Any active, known, or suspected autoimmune disease. Stable subjects not requiring systemic immunosuppressive therapy may be included, such as those with type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, and skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, and alopecia).
  • Interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, and acute pneumonia).
  • Pregnant or lactating women or females with a positive pregnancy test prior to the first dose who have the potential for pregnancy.
  • The investigator deems the subject inappropriate for participation in this clinical study due to any clinical or laboratory abnormalities or compliance issues.
  • Severe psychological or mental abnormalities.
  • Participation in another drug clinical trial within the past 4 weeks.
  • Other reasons that the investigator considers unsuitable for enrollment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhiyong Huang contact

86-13995507729

Zyhuang126@126.com

Erlei Zhang contact

baiyu19861104@163.com

China1 site, 1 recruiting

  • Tongji Hospital

    Wuhan, Hubei

    Zhiyong Huang, 86-13995507729, Zyhuang126@126.com

    Erlei Zhang, baiyu19861104@163.com

    Recruiting

Other trials in China

About this study

Hepatocellular carcinoma (HCC) is one of the most common malignant tumors and the leading cause of cancer-related death worldwide. Surgical resection has always been the best hope for long-term survival of patients with HCC. However, due to the fact that most patients are already in the middle and late stages of treatment, only about 20% of patients have the opportunity to undergo surgical resection. Palliative cytoreductive surgery has been used in the treatment of a variety of malignant tumors, but it is not recommended for the treatment of HCC. Under the premise of targeted therapy and immunotherapy, palliative hepatectomy can reduce tumor burden and may further improve the therapeutic effect of HCC. The aim of this study is to explore whether palliative hepatectomy combined with targeted therapy and immunotherapy can improve the therapeutic effect of advanced HCC, ultimately prolong the survival time of patients, and provide a new treatment direction for patients with advanced HCC.

Read the detailed description

This study is a prospective, multicenter, single-arm clinical study aimed at evaluating targeted therapy and immunotherapy combined with palliative hepatectomy for the treatment of advanced hepatocellular carcinoma. Patients who have been assessed as stage B or C of Barcelona Clinic Liver Cancer (BCLC) will receive local treatment (transcatheter arterial chemoembolization (TACE) or transcatheter arterial chemoembolization (HAIC)) or 90Y-SIRT (yttrium-90 selective internal radiation therapy) combined with Lenvatinib and Durvalumab. After receiving three months of combined treatment, patients in the stable disease (SD) or progressive disease (PD) stage who have poor efficacy evaluated by imaging will undergo palliative hepatectomy; patients in the complete response (CR) or partial response (PR) stage after imaging evaluation will be excluded and continue to receive systematic treatment. Patients need to discontinue targeted therapy and immunotherapy one week before surgery.

Being tested
Palliative Hepatectomy, Durvalumab, Lenvatinib
Keywords
HCC, Palliative Hepatectomy, Immunotherapy, Targeted therapy

What participants receive

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

  • Palliative HepatectomyProcedure or surgery

    Patients will receive TACE, HAIC, or 90Y-SIRT combined with Lenvatinib and Durvalumab. After receiving three months of combined treatment, patients in the SD or PD stage who have poor efficacy evaluated by imaging will undergo palliative hepatectomy.

    Palliative Hepatectomy:① Intrahepatic metastasis: complete lesion resection of the main tumor on one side of the liver; ② Extrahepatic metastasis: complete lesion resection of intrahepatic lesions; ③ Merge portal vein tumor thrombus or hepatic vein tumor thrombus: remove the tumor thrombus and completely remove the intrahepatic lesions. And reduce the tumor burden by more than 90% through surgical resection.

  • DurvalumabDrug

    Also called IMFINZ

    Starting two weeks post-surgery, patients began intravenous infusions of the PD-L1 monoclonal antibody, Durvalumab.

  • LenvatinibDrug

    Also called LENVIMA

    Three weeks post-surgery, patients commenced oral administration of Lenvatinib.

Study groups in NCT06470256
Study groupRoleWhat they receive
Palliative Hepatectomy Combined With Targeted Therapy and ImmunotherapyExperimentalReduce tumor burden by over 90% through palliative hepatectomy . Starting two weeks post-surgery, patients began intravenous infusions of the PD-L1 monoclonal antibody, Durvalumab, at a dosage of 1500 mg every three weeks. Three weeks post-surgery, patients commenced oral administration of the targeted therapy, Lenvatinib, with a dosage based on body weight: 8 mg (≤60 kg) or 12 mg (>60 kg), once daily. The use of Durvalumab and Lenvatinib continued until the primary endpoint or other criteria specified in the protocol for terminating the study treatment.
Receives: Procedure: Palliative Hepatectomy; Drug: Durvalumab; Drug: Lenvatinib

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR refers to the proportion of patients whose tumors shrink to a certain amount and maintain for a certain period of time (6 weeks after first dose of Durvalumab), including CR+PR cases. CR (complete response): disappearance of all target lesions, PR (partial response): reduction of the sum of the length and diameter of the baseline lesions by ≥30%.

    Measured: 6 weeks after first dose of Durvalumab

Secondary outcomes (2)

  1. Overall Survival (OS)

    OS was defined as time from diagnosis to death from any cause or the last follow-up

    Measured: through study completion, an average of 2 year

  2. Progression Free Survival (PFS)

    PFS refers to the time from subject enrollment to disease progression according the Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1) or death

    Measured: 18 months

Timeline

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

  1. First posted24 Jun 2024
  2. Study start1 Jun 2024
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Jun 2028 (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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06470256
Sponsor's protocol ID
aHCC-PHTI-TJ01
Status last verified
Jun 2024
First submitted
17 Jun 2024
Last updated
24 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Palliative Hepatectomy, Durvalumab and Lenvatinib in people with Advanced Hepatocellular Carcinoma, run by Zhiyong Huang 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 11 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 24 Jun 2024. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Zhiyong Huang (86-13995507729, Zyhuang126@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: 6 weeks after first dose of Durvalumab). 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 NCT06470256.

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 24 Jun 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in