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Hepatocellular Carcinoma Non-resectablePhase 2NCT04599790

TACE Combined With Lenvatinib and Sintilimab for Advanced HCC

A Phase 2 study testing TACE combined with lenvatinib and sintilimab in people with Hepatocellular Carcinoma Non-resectable, run by Second Affiliated Hospital of Guangzhou Medical 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 will evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and sintilimab in patients with unresectable advanced hepatocellullar carcinoma (HCC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma Non-resectable
What is being tested?
TACE combined with lenvatinib and sintilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Oct 2020to 31 Oct 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Advanced HCC (BCLC stage C, or CNLC IIIa and IIIb ) with diagnosis confirmed by histology/cytology or clinically
  • Disease not amenable to curative therapies but amenable to TACE
  • At least one measurable untreated lesion
  • No prior systemic therapy for HCC
  • Child-Pugh score 5-7
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
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  • Adequate organ and hematologic function
  • Life expectancy of at least 3 months
  • For women of childbearing potential and for men: agreement to remain abstinent

Who cannot join

  • Diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • Diffuse HCC
  • Portal vein tumor thrombus (PVTT) involves the main trunk and contralateral branch or upper mesenteric vein
  • Inferior vena cava tumor thrombus
  • Metastatic disease that involves major airways or blood vessels
  • Symptomatic, untreated or progressing central nervous system metastasis
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  • Uncontrolled tumor-related pain
  • Patients who received prior systemic therapy, immunotherapy, TACE, transcatheter arterial radioembolization (TARE), transcatheter arterial embolization (TAE), hepatic arterial infusion chemotherapy (HAIC) or radiation therapy for HCC
  • Treatment with systemic immunostimulatory agents
  • Use of herbal therapies or traditional Chinese medicines with anti-cancer activity within 2 weeks
  • History of malignancy other than HCC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death
  • Uncontrolled ascites, hydrothorax or pericardial effusion
  • Prior esophageal and/or gastric varices bleeding within 6 months prior to initiation of study treatment
  • Prior life-threatening blood loss or grade 3/4 gastrointestinal bleeding requiring blood infusion, endoscopic or surgical intervention within 3 months
  • Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high-risk for bleeding
  • History of gastrointestinal (GI) perforation and/or fistula in the past 6 months history of GI obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection, complicated by chronic diarrhea), Crohn's disease, ulcerative colitis or long-term chronic diarrhea
  • History of hepatic encephalopathy
  • History of organ and stem cell transplantation
  • Long-term daily treatment with a non-steroidal anti-inflammatory drug (NSAID)
  • Use of immunosuppressive drugs in the past 4 weeks, excluding the routes of topical glucocorticoids or physiological doses of systemic glucocorticoids (ie no more than 10 mg/day of prednisone or equivalent). Temporary use of glucocorticoids for dyspnea symptoms such as asthma and chronic obstructive pulmonary disease is allowed
  • History of idiopathic pulmonary fibrosis, interstitial pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
  • Active tuberculosis
  • Active severe infection; use of antibiotics within 2 weeks prior to injection of tislelizumab
  • Autoimmune disease or immune deficiency
  • Inadequately controlled hypertension; history of hypertensive crisis or hypertensive encephalopathy
  • Bleeding diathesis or significant coagulopathy
  • Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture underwent major surgery (craniotomy, thoracotomy or open surgery) within 4 weeks; non-recovery from side effects of these procedure
  • History of venous thromboembolism in the past 6 months, but implantable IV ports or catheter-derived thrombosis, superficial venous thrombosis, or thrombosis after conventional anticoagulant therapy are excluded
  • Current or recent use of aspirin or treatment with dipyramidole, ticlopidine, clopidogrel, or cilostazol uncontrolled metabolic disorder, non-malignant organ or systemic disease or secondary carcinomatous reaction, with high medical risk and/or uncertainty of life expectancy evaluation
  • Other acute or chronic diseases, mental illness, or abnormal laboratory test results that may lead to the following outcomes: increase the risk of participating in study or study drug administration, or interfere with the interpretation of the study results and considered by investigator as "NOT" eligible to participate in this study
  • Female patients who are pregnancy or breastfeeding

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

Other trials in China

About this study

Official title: Transcatheter Arterial Chemoembolization Combined With Lenvatinib and Sintilimab for Unresectable Advanced Hepatocellular Carcinoma: An Open-label, Single-arm, Single-center, Prospective Study

This study will evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and sintilimab in patients with unresectable advanced hepatocellullar carcinoma (HCC).

Read the detailed description

This is a Phase II study to evaluate the efficacy and safety of TACE combined with lenvatinib and sintilimab in patients with advanced HCC.

30 subjects with advanced HCC (Barcelona-Clinic- Liver-Cancer [BCLC] stage C, or China liver cancer staging [CNLC] IIIa and IIIb) will be enrolled in the study.

Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd and sintilimab (200mg I.V. q3w) will be started at 3-7 days after the first TACE. TACE will be repeated if clinically indicated based on the evaluation of follow-up laboratory and imaging examination. Lenvatinib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Patients will be allowed to have lenvatinib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.

Being tested
TACE combined with lenvatinib and sintilimab

What participants receive

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

  • TACE combined with lenvatinib and sintilimabDrug

    Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd and sintilimab 200mg I.V. q3w will be started at 3-7 days after the first TACE.TACE will be repeated if clinically indicated. Treatment of sintilimab will last up to 24 months. Patients will be allowed to have lenvatilib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.

Study groups in NCT04599790
Study groupRoleWhat they receive
TACE-Len-SinExperimentalTACE combined with lenvatinib and sintilimab.
Receives: Drug: TACE combined with lenvatinib and sintilimab

What is being measured

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

  1. Progression free survival (PFS) assessed by investigators according to Modified RECIST (mRECIST)

    The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.

    Measured: 24 months

Secondary outcomes (9)

  1. Adverse Events (AEs)

    Number of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), AE of special interest (AESI), serious adverse event (SAE), assessed by NCI CTCAE v5.0.

    Measured: 24 months

  2. Progression free survival (PFS) assessed by investigators according to Response Evalutaion Criteria in Solid Tumors (RECIST) v1.1 and immune-related RECIST (irRECIST).

    The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.

    Measured: 24 months

  3. Objective response rate (ORR) assessed by investigators according to RECIST 1.1 and irRECIST.

    The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR).

    Measured: 24 months

  4. Disease control rate (DCR) assessed by investigators according to RECIST 1.1 and irRECIST.

    The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD).

    Measured: 24 months

  5. Duration of response (DOR) assessed by investigators according to RECIST 1.1 and irRECIST.

    The time from the first occurrence of a documented objective response to disease progression (PD) or death.

    Measured: 24 months

  6. Overall survival (OS)

    The time from initiation of treatment until the date of death from any cause.

    Measured: 24 months

  7. ORR assessed by investigators according to mRECIST.

    The percentage of patients who had a best overall tumor response rating of CR or PR.

    Measured: 24 months

  8. DCR assessed by investigators according to mRECIST.

    The percentage of patients who had a tumor response rating of CR, PR, or SD.

    Measured: 24 months

  9. DOR assessed by investigators according to mRECIST.

    The time from the first occurrence of a documented objective response to PD or death.

    Measured: 24 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 Oct 2020
  2. Study start1 Oct 2020
  3. Primary completion29 Nov 2021
  4. Study completion31 Oct 2022

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 (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04599790
Sponsor's protocol ID
MIIR-04
Status last verified
Feb 2022
First submitted
19 Oct 2020
Last updated
10 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cai M, Huang W, Liang W, Guo Y, Liang L, Lin L, Xie L, Zhou J, Chen Y, Cao B, Wu J, Zhu K. Lenvatinib, sintilimab plus transarterial chemoembolization for advanced stage hepatocellular carcinoma: A phase II study. Liver Int. 2024 Apr;44(4):920-930. doi: 10.1111/liv.15831. Epub 2024 Jan 30.

    PubMed 38291865

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TACE combined with lenvatinib and sintilimab in people with Hepatocellular Carcinoma Non-resectable, run by Second Affiliated Hospital of Guangzhou Medical 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 9 inclusion and 31 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 10 Nov 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?

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?

Progression free survival (PFS) assessed by investigators according to Modified RECIST (mRECIST) (time frame: 24 months). 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 NCT04599790, 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 10 Nov 2022.

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