Evidence map›Paper›PMID 32716739›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020

Phase Ib Study of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma.

Richard S Finn, Masafumi Ikeda, Andrew X Zhu, Max W Sung, Ari D Baron, Masatoshi Kudo, Takuji Okusaka, Masahiro Kobayashi, Hiromitsu Kumada, Shuichi Kaneko and 10 more

8 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 8 registered trials, which are not on this map. Cited by 818 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
818citing papers in PubMed, 6 pooled it
98.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04994236 phase2unknown statusnot on this mapstarted 2021, after this paper: background citation

Efficacy and Safety of Hepatic Artery Infusion Chemotherapy in Patients With Advanced or Unresectable Hepatocellular Carcinoma Who Have Progressed or Are Intolerant to Systemic Therapy

TypeinterventionalSponsorHui-Chuan SunRan2021 to 2022Enrolled49ConditionsHepatocellular CarcinomaArmsHepatic artery infusion chemotherapy with FOLFOX regimens (oxaliplatin, fluorouracil, and leucovorin)
NCT05062837 phase2 / phase3unknown statusnot on this mapstarted 2021, after this paper: background citation

Hepatectomy Combined With Camrelizumab and Apatinib in CNLC Stage IIIb Hepatocellular Carcinoma

TypeinterventionalSponsorGuangxi Medical UniversityRan2021 to 2024Enrolled62ConditionsHepatocellular CarcinomaArmsHepatectomy Combined With Camrelizumab and Apatinib
NCT05233358 naunknown statusnot on this mapstarted 2022, after this paper: background citation

HAIC Combined With Second-line "Target Immunity" for Advanced Hepatocellular Carcinoma With Low Response or Failure of TACE Combined With First-line "Target Immunity": A Prospective, Randomized- Control, Multicenter Clinical Trial

TypeinterventionalSponsorThe Central Hospital of Lishui CityRan2022 to 2025Enrolled176ConditionsHepatocellular CarcinomaArmsHepatic Artery Infusion Chemotherapy, Transarterial Chemoembolization, Regorafenib, Immune Checkpoint Inhibitors
NCT05389527 phase2unknown statusnot on this mapstarted 2022, after this paper: background citation

Efficacy and Safety of the Combination of Pembrolizumab and Lenvatinib as Neoadjuvant Treatment for Hepatocellular Carcinoma Patients

TypeinterventionalSponsorShanghai Zhongshan HospitalRan2022 to 2025Enrolled43ConditionsCarcinoma, HepatocellularArmsPembrolizumab+Lenvatinib
NCT05831969 phase2unknown statusnot on this mapstarted 2023, after this paper: background citation

Lenalidomide to Reverse Drug Resistance After Lenvatinib Combined With PD-1 Inhibitors in the First-line Treatment of Advanced HCC ：a Prospective, Exploratory, Single-arm, Open-label, Multi-center Clinical Study

TypeinterventionalSponsorShenyang Tenth People's HospitalRan2023 to 2025Enrolled23ConditionsAdvanced HCCArmsLenalidomide
NCT06261125 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

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

TypeinterventionalSponsorMian XIRan2024 to 2028Enrolled60ConditionsHepatocellular CarcinomaArmsStereotactic body radiotherapy, Adebrelimab, Lenvatinib
NCT06278701 naunknown statusnot on this mapstarted 2023, after this paper: background citation

Effects of Late-evening Snacks on Nutritional Status and Metabolic Pattern of Patients With Primary Hepatocellular Carcinoma After Hepatectomy

TypeinterventionalSponsorDU YaoRan2023 to 2025Enrolled106ConditionsLiver NeoplasmsArmslate-evening snacks
NCT06685354 phase2not yet recruitingnot on this mapstarted 2024, after this paper: background citation

Sequential Targeted and Immunotherapy With Recombined Human Type 5 Adenovirus Via Hepatic Arterial Infusion for BCLC Stage C Hepatocellular Carcinoma: A Prospective Single-Center Single-Arm Pilot Study

TypeinterventionalSponsorHenan Cancer HospitalRan2024 to 2026Enrolled11ConditionsHepatocellular Carcinoma (HCC)Armshepatic arterial infusion of recombinant human type 5 adenovirus
3 · Its place in the literature

Who cites it

818 citing papers in PubMed, 6 syntheses or guidelines pooled it, 1,150 citations in OpenAlex.

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  10. Cabozantinib plus Atezolizumab in Advanced, Progressive Endocrine Malignancies: A Multicohort, Basket, Phase II Trial (CABATEN/GETNE-T1914).Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
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758 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 15 institutions in 6 countries.

Richard S FinnDavid Geffen School of Medicine, University of California Los Angeles Medical Center, Los Angeles, CA.
Masafumi IkedaDepartment of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Andrew X ZhuMassachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA.
Max W SungTisch Cancer Institute at Mount Sinai, New York, NY.
Ari D BaronSutter Health/California Pacific Medical Center Research Institute, San Francisco, CA.
Masatoshi KudoDepartment of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.
Takuji OkusakaDepartment of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Masahiro KobayashiDepartment of Hepatology, Toranomon Hospital, Tokyo, Japan.
Hiromitsu KumadaDepartment of Hepatology, Toranomon Hospital, Tokyo, Japan.
Shuichi KanekoInstitute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Japan.
Marc PrachtCentre Eugène Marquis, Rennes, France.
Konstantin MamontovAltay Regional Oncological Hospital, Barnaul, Russian Federation.
Tim MeyerRoyal Free London National Health Service Foundation Trust, London, United Kingdom.
Tomoki KubotaEisai, Tokyo, Japan.
Corina E DutcusEisai, Woodcliff Lake, NJ.
Kenichi SaitoEisai, Woodcliff Lake, NJ.
Abby B SiegelMerck, Kenilworth, NJ.
Leonid DubrovskyMerck, Kenilworth, NJ.
Kalgi ModyEisai, Woodcliff Lake, NJ.
Josep M LlovetLiver Cancer Program, Division of Liver Diseases, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
Eisai (United States) · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USToranomon Hospital · JPCentre Eugène Marquis · FREisai (Japan) · JPHarvard University · USKanazawa University · JPKindai University · JPNational Cancer Center Hospital East · JPRegional Public Health Care Institution "City Hospital No. 5, Barnaul" · RURoyal Free London NHS Foundation Trust · GBSutter Health · USTisch Cancer InstituteUniversitat de Barcelona · ESUniversity of California, Los Angeles · US

Funding

Cancer Research UK 26813
6 · The paper itself

Abstract

purposeThe immunomodulatory effect of lenvatinib (a multikinase inhibitor) on tumor microenvironments may contribute to antitumor activity when combined with programmed death receptor-1 (PD-1) signaling inhibitors in hepatocellular carcinoma (HCC). We report results from a phase Ib study of lenvatinib plus pembrolizumab (an anti-PD-1 antibody) in unresectable HCC (uHCC). PATIENTS AND

methodsIn this open-label multicenter study, patients with uHCC received lenvatinib (bodyweight ≥ 60 kg, 12 mg; < 60 kg, 8 mg) orally daily and pembrolizumab 200 mg intravenously on day 1 of a 21-day cycle. The study included a dose-limiting toxicity (DLT) phase and an expansion phase (first-line patients). Primary objectives were safety/tolerability (DLT phase), and objective response rate (ORR) and duration of response (DOR) by modified RECIST (mRECIST) and RECIST version 1.1 (v1.1) per independent imaging review (IIR; expansion phase).

resultsA total of 104 patients were enrolled. No DLTs were reported (n = 6) in the DLT phase; 100 patients (expansion phase; included n = 2 from DLT phase) had received no prior systemic therapy and had Barcelona Clinic Liver Cancer stage B (n = 29) or C disease (n = 71). At data cutoff, 37% of patients remained on treatment. Median duration of follow-up was 10.6 months (95% CI, 9.2 to 11.5 months). Confirmed ORRs by IIR were 46.0% (95% CI, 36.0% to 56.3%) per mRECIST and 36.0% (95% CI, 26.6% to 46.2%) per RECIST v1.1. Median DORs by IIR were 8.6 months (95% CI, 6.9 months to not estimable [NE]) per mRECIST and 12.6 months (95% CI, 6.9 months to NE) per RECIST v1.1. Median progression-free survival by IIR was 9.3 months per mRECIST and 8.6 months per RECIST v1.1. Median overall survival was 22 months. Grade ≥ 3 treatment-related adverse events occurred in 67% (grade 5, 3%) of patients. No new safety signals were identified.

conclusionLenvatinib plus pembrolizumab has promising antitumor activity in uHCC. Toxicities were manageable, with no unexpected safety signals.

Indexed as

AgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, HepatocellularDisease ProgressionFemaleHumansLiver NeoplasmsMaleMiddle AgedNeoplasm StagingPhenylurea CompoundsProgression-Free SurvivalQuinolinesTime FactorsAntibodies, Monoclonal, HumanizedlenvatinibpembrolizumabPhenylurea CompoundsQuinolines

Identifiers

PMID32716739
PMCPMC7479760
OpenAlexW3045387409

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

and 2 more above

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.