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Hepatocellular CarcinomaPhase 2HSBRT2401NCT06261125

Combination of SBRT, PD-L1 Inhibitor, and Lenvatinib in Hepatocellular Carcinoma (HSBRT2401)

A Phase 2 study testing Stereotactic body radiotherapy, Adebrelimab and Lenvatinib in people with Hepatocellular Carcinoma, run by Mian XI 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
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Trial summary

Abdominal lymph node metastasis (LNM) is one of the major modes of extrahepatic metastasis in hepatocellular carcinoma (HCC). Immunotherapy targeting the PD-1/PD-L1 checkpoints combined with targeted therapy is the standard treatment for HCC with abdominal LNM, but the outcome remains very poor, with an objective… 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?
Stereotactic body radiotherapy, Adebrelimab and Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
10 Mar 2024to 30 Jun 2028
Phase
Phase 2
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

  • Histologically confirmed hepatocellular carcinoma or diagnosed by American Association for the Study of Liver Disease criteria;
  • Presence of abdominal metastatic lymph nodes confirmed by CT or MRI, the sum of the maximum diameter of lymph nodes ≤10 cm, and at least one of which is measurable according to the RECIST 1.1 Criteria;
  • Previous local treatment for intrahepatic lesion and systemic anti-tumor therapy are allowed; no matter whether the disease progressed or not;
  • Less than 3 active intrahepatic lesions with a total diameter of less than 10 cm; Portal vein invasion is allowed; absence of other extrahepatic metastasis disease except abdominal LNM;
  • Cohort 1: Patients who never received PD-1/PD-L1 antibody therapy; Cohort 2: patients who had tumor progression after previous PD-1/PD-L1 antibody therapy.
  • Age at diagnosis 18 to 75 years;
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  • Eastern Cooperative Oncology Group performance status ≤ 2
  • Child-Pugh class A liver function;
  • Normal liver volume greater than 700 ml;
  • Estimated life expectancy ≥12 weeks;
  • The function of important organs meets the following requirements: a. white blood cell count (WBC) ≥ 3.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L; b. platelets ≥ 50×109/L; c. hemoglobin ≥ 9g/dL; d. serum albumin ≥ 2.8g/dL; e. total bilirubin ≤ 1.5×ULN, ALT, AST and/or AKP ≤ 2.5×ULN; f. serum creatinine ≤ 1.5×ULN or creatinine clearance rate >60 mL/min;
  • Ability to understand the study and sign informed consent.

Who cannot join

  • Diffuse hepatocellular carcinoma;
  • Patients who have previously been treated with lenvatinib or PD-1/PD-L1 antibody but could not be tolerated;
  • Patients with other extrahepatic metastasis disease except abdominal LNM;
  • A history of abdominal radiotherapy;
  • Known or suspected allergy or hypersensitivity to monoclonal antibodies;
  • Patients who have a preexisting or coexisting bleeding disorder;
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  • Female patients who are pregnant or lactating;
  • Inability to provide informed consent due to psychological, familial, social and other factors;
  • A history of malignancies other than hepatocellular carcinoma before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer;
  • A history of diabetes for more than 10 years and poorly controlled blood glucose levels;
  • Patients who cannot tolerate radiotherapy due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia;
  • Active autoimmune diseases, a history of autoimmune diseases (including but not limited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism), a history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation;
  • A history of interstitial lung disease or non-infectious pneumonia;
  • A history of active pulmonary tuberculosis infection within 1 year or a history of active pulmonary tuberculosis infection more than 1 year ago but without formal anti-tuberculosis treatment;
  • Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay);
  • Any unstable situation that may endanger the safety and compliance of patients.

Trial locations and contacts

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

Mian Xi, MD contact

+862087343385

ximian@sysucc.org.cn

China1 site, 1 recruiting

  • Mian Xi

    Guangzhou, Guangdong, 510060

    Mian Xi, MD, +862087343385, ximian@sysucc.org.cn

    Mian Xi, MD

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Stereotactic Body Radiotherapy Followed by Adebrelimab and Lenvatinib for Hepatocellular Carcinoma With Abdominal Lymph Node Metastases: A Two-arm, Phase II Trial

Abdominal lymph node metastasis (LNM) is one of the major modes of extrahepatic metastasis in hepatocellular carcinoma (HCC). Immunotherapy targeting the PD-1/PD-L1 checkpoints combined with targeted therapy is the standard treatment for HCC with abdominal LNM, but the outcome remains very poor, with an objective response rate of 5% to 30%. Previous studies have demonstrated that stereotactic body radiotherapy (SBRT) is an effective local treatment for HCC with abdominal LNM, with a high response rate of 60% to 80%. However, intrahepatic dissemination and distant metastasis remains the major recurrence pattern after SBRT in these patients, suggesting radiotherapy should be combined with systematic treatment. Recently, the combination of immunotherapy with SBRT has shown promising activity in HCC. The aim of this study was to investigate the efficacy and safety of SBRT followed by adebrelimab (an anti-PD-L1 antibody) and lenvatinib in HCC patients with portal abdominal LNM.

Read the detailed description

A total of 60 HCC patients (2 cohorts) with abdominal LNM will be enrolled to receive SBRT followed by adebrelimab (an anti-PD-L1 antibody) and lenvatinib. Arm A included the patients who previously had not received PD-1/PD-L1 antibody, and Arm B included the patients who had progressed after receiving PD-1/PD-L1 antibody.

Patients in both cohorts will receive stereotactic body radiotherapy (SBRT) using volumetric arc therapy. The prescribed dose is 33-48 Gy in 6 fractions over 2 weeks. Then all patients will receive lenvatinib (12 mg/day for bodyweight ≥60 kg or 8 mg/day for bodyweight <60 kg) orally once daily in combination with adebrelimab 1200 mg every 3 weeks for up to 35 cycles. The first course of adebrelimab will be given within 1 week after completion of SBRT.

Being tested
Stereotactic body radiotherapy, Adebrelimab, Lenvatinib
Keywords
Hepatocellular carcinoma, Radiotherapy, Immunotherapy, Targeted therapy
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Stereotactic body radiotherapyRadiation

    Also called SBRT

    Patients in both cohorts will receive stereotactic body radiotherapy (SBRT) using volumetric arc therapy. The prescribed dose is 33-48 Gy in 6 fractions over 2 weeks.

  • AdebrelimabDrug

    Also called SHR-1316

    All patients will reveive adebrelimab 1200 mg every 3 weeks for up to 35 cycles after the completion of SBRT.

  • LenvatinibDrug

    Also called Lenvima

    All patients will receive lenvatinib (12 mg/day for bodyweight ≥60 kg or 8 mg/day for bodyweight <60 kg) orally once daily after the completion of SBRT.

Study groups in NCT06261125
Study groupRoleWhat they receive
Arm AExperimentalThis arm includes the patients who previously had not received PD-1/PD-L1 antibody. Patients assigned to this arm will receive SBRT followed by adebrelimab and lenvatinib. The prescribed dose of SBRT is 33-48 Gy in 6 fractions over 2 weeks. Then all patients will receive lenvatinib (12 mg/day for bodyweight ≥60 kg or 8 mg/day for bodyweight <60 kg) orally once daily in combination with adebrelimab 1200 mg every 3 weeks for up to 35 cycles. The first course of adebrelimab will be given within 1 week after completion of SBRT.
Receives: Radiation: Stereotactic body radiotherapy; Drug: Adebrelimab; Drug: Lenvatinib
Arm BExperimentalThis arm includes the patients who had progressed after receiving PD-1/PD-L1 antibody. Patients assigned to this arm will receive SBRT followed by adebrelimab and lenvatinib. The prescribed dose of SBRT is 33-48 Gy in 6 fractions over 2 weeks. Then all patients will receive lenvatinib (12 mg/day for bodyweight ≥60 kg or 8 mg/day for bodyweight <60 kg) orally once daily in combination with adebrelimab 1200 mg every 3 weeks for up to 35 cycles. The first course of adebrelimab will be given within 1 week after completion of SBRT.
Receives: Radiation: Stereotactic body radiotherapy; Drug: Adebrelimab; Drug: Lenvatinib

What is being measured

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

  1. Progression-free survival (PFS)

    Three-year follow-up from the date of enrollment to the date of disease progression or last follow-up

    Measured: From date of enrollment until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 36 months.

Secondary outcomes (5)

  1. Overall survival (OS)

    Three-year follow-up from the enrollment to the date of death from any cause or date of lost follow-up

    Measured: From date of enrollment until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 36 months.

  2. Overall response rate (ORR)

    Tumor response was evaluated every 9 weeks after the completion of radiotherapy based on CT or MRI scan.

    Measured: From date of enrollment to the date of last follow-up, assessed up to 36 months.

  3. Disease control rate (DCR)

    The proportion of patients with complete response, partial response, or stable disease according to RECIST criteria.

    Measured: From date of enrollment to the date of last follow-up, assessed up to 36 months.

  4. Duration of response (DOR)

    From the date of first CR/PR to the date of first PD.

    Measured: From date of first CR/PR to the date of first PD according to RECIST criteria, assessed up to 36 months.

  5. Treatment-related adverse events

    Incidence of treatment-related adverse events as assessed by CTCAE v4.0.

    Measured: From date of enrollment to the date of last follow-up, assessed up to 36 months.

Timeline

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

  1. First posted15 Feb 2024
  2. Study start10 Mar 2024
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06261125
Sponsor's protocol ID
SL-B2023-718
Acronym
HSBRT2401
Status last verified
Mar 2024
First submitted
8 Feb 2024
Last updated
12 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make IPD available to other researchers.

Publications

  • Wang Y, Li Q, Zhang L, Liu S, Zhu J, Yang Y, Liu M, Zhang Y, Xi M. Efficacy and Dose-Response Relationship of Stereotactic Body Radiotherapy for Abdominal Lymph Node Metastases from Hepatocellular Carcinoma. Oncologist. 2023 Jun 2;28(6):e369-e378. doi: 10.1093/oncolo/oyad083.

    PubMed 37011232

  • Kim HJ, Park S, Kim KJ, Seong J. Clinical significance of soluble programmed cell death ligand-1 (sPD-L1) in hepatocellular carcinoma patients treated with radiotherapy. Radiother Oncol. 2018 Oct;129(1):130-135. doi: 10.1016/j.radonc.2017.11.027. Epub 2018 Jan 30.

    PubMed 29366520

  • Chiang CL, Chiu KWH, Chan KSK, Lee FAS, Li JCB, Wan CWS, Dai WC, Lam TC, Chen W, Wong NSM, Cheung ALY, Lee VWY, Lau VWH, El Helali A, Man K, Kong FMS, Lo CM, Chan AC. Sequential transarterial chemoembolisation and stereotactic body radiotherapy followed by immunotherapy as conversion therapy for patients with locally advanced, unresectable hepatocellular carcinoma (START-FIT): a single-arm, phase 2 trial. Lancet Gastroenterol Hepatol. 2023 Feb;8(2):169-178. doi: 10.1016/S2468-1253(22)00339-9. Epub 2022 Dec 15.

    PubMed 36529152

  • Finn RS, Ikeda M, Zhu AX, Sung MW, Baron AD, Kudo M, Okusaka T, Kobayashi M, Kumada H, Kaneko S, Pracht M, Mamontov K, Meyer T, Kubota T, Dutcus CE, Saito K, Siegel AB, Dubrovsky L, Mody K, Llovet JM. Phase Ib Study of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma. J Clin Oncol. 2020 Sep 10;38(26):2960-2970. doi: 10.1200/JCO.20.00808. Epub 2020 Jul 27.

    PubMed 32716739

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stereotactic body radiotherapy, Adebrelimab and Lenvatinib in people with Hepatocellular Carcinoma, run by Mian XI 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 12 inclusion and 16 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 12 Mar 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 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?

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 Mian Xi, MD (+862087343385, ximian@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: From date of enrollment until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 36 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 NCT06261125, which also lists 4 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 12 Mar 2024.

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