AzTrials
AzTrials

CholangiocarcinomaPhase 2LENABCNCT04656249

Lenvatinib in Patients With Previously Treated Advanced Biliary Tract Cancer

A Phase 2 study testing Lenvatinib in people with Cholangiocarcinoma and Biliary Tract Cancer, run by Peking Union Medical College Hospital 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
Search all trials

Trial summary

This is a single center, nonrandom, open-label study aiming to evluate the efficacy and safety of lenvatinib for patients with pretreated advanced biliary tract cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lenvatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
1 Jan 2018to 1 May 2021
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

  • Pathologically or cytologically confirmed adenocarcinoma of biliary tract cancer (intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer), at least one prior chemotherapy.
  • Participants who received adjuvant chemotherapy are eligible if this therapy was completed and recurrent has not been shown for 6 months after the completion of the therapy
  • Measurable disease meeting the following criteria: At least 1 lesion of ≥ 1.0 cm in the longest diameter for a non-lymph node or ≥ 1.5 cm in the short-axis diameter for a lymph node that is serially measurable according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST1.1) using computerized tomography/magnetic resonance imaging (CT/MRI). Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Survival expectation of 3 months or longer after beginning of study treatment
  • Males or females age ≥ 18 years at the time of informed consent
Show all 12Show fewer
  • All chemotherapy- or radiation-related toxicities must have resolved to Grade 0-1 per Common Terminology Criteria for Adverse Events (CTCAE v 4.03), except alopecia, infertility, and the adverse events listed in inclusion criteria
  • Adequately controlled blood pressure (BP) with or without antihypertensive medications (defined as BP ≤ 150/90 mm Hg at Screening and no change in antihypertensive medications within 1 week prior to the first dose of study drug)
  • Participants with adequate function of major organs and blood coagulation:
  • Absolute neutrophil count (ANC) ≥ 1500/mm^3 ( ≥ 1.5×103/μl); Platelets ≥ 100,000/mm3 ( ≥ 100×10^9/L); Hemoglobin ≥ 9.0 g/dL; Bilirubin ≤ 2.0 mg/dL except for unconjugated hyperbilirubinemia or Gilbert's syndrome; Alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤ 3.0 × upper limit of normal (ULN) ( ≤ 5.0 × ULN for participants with the liver metastasis); Creatinine clearance ≥ 40 mL/min per the Cockcroft and Gault formula; Prothrombin time-International Normalized Ratio (PT-INR) ≤ 1.5;
  • Participants must voluntarily agree to provide written informed consent;
  • Participants must be willing and able to comply with all aspects of the protocol

Who cannot join

  • Ascites of moderate, severe, or requiring drainage
  • Proteinuria of ≥ 2+ on dipstick testing (Grade ≤ 1 confirmed by quantitative assessment is eligible)
  • Gastrointestinal malabsorption or any other condition that in the opinion of the investigator might affect the absorption of study drug
  • New York Heart Association congestive heart failure of class II or above, unstable angina, myocardial infarction, or serious cardiac arrhythmia associated with significant cardiovascular impairment within the past 6 months from the first dose of study drug
  • A prolonged QT/QTc interval (QTcF > 480 ms)
  • Known to be human immunodeficiency virus (HIV) positive
Show all 14Show fewer
  • Active infection requiring systemic treatment
  • Bleeding or thrombotic disorders or chronic systemic use of anticoagulants requiring therapeutic INR monitoring, eg, warfarin or similar agents (treatment with low molecular weight heparin is permitted)
  • Gastrointestinal bleeding event or active hemoptysis (bright red blood of at least 0.5 teaspoon) within 21 days prior to the first dose of study drug Active malignancy (except for BTC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, carcinoma in-situ of the cervix, or early stage gastric/colorectal cancer) within the past 24 months prior to the first dose of study drug
  • Known intolerance to the study drug or any of the excipients
  • History of drug or alcohol dependency or abuse within the last 24 months prior to the first dose of study drug
  • Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study
  • Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive human chorionic gonadotropin [hCG or B-hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 3 days before the first dose of study drug.
  • For either males unless undergoing a successful vasectomy (confirmed azoospermia) or females of childbearing potential, the participant and his/her partner do not agree to use a medically appropriate method of contraception throughout the entire study period

Trial locations and contacts

1 site in 1 country.

China1 site

  • Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: The Efficacy and Safety of Lenvatinib in Patients With Previously Treated Advanced Biliary Tract Cancer

This is a single center, nonrandom, open-label study aiming to evluate the efficacy and safety of lenvatinib for patients with pretreated advanced biliary tract cancer.

Read the detailed description

Lenvatinib targets VEGFR1, 2, and 3, PDGFRα, Fibroblast growth factor receptor (FGFR), and the KIT and RET tyrosine kinases and was initially developed for use in various tumor types. This is a single-center, non-random, open-label study in participants with unresectable BTC and disease progression or failure following at least one chemotherapy regimen. This study contains three procedures: a pre-treatment procedure that will last within 21 days; a treatment procedure that will consist of study treatment cycles and tumor assessment conducted every 6-8 weeks; and a follow-up procedure that will begin immediately after the off-treatment visit and will continue as long as the participant is alive, unless the participant withdraws consent, or until the terminal of the study.

Being tested
Lenvatinib
Keywords
Lenvatinib, Refractory biliary tract carcinoma, Efficacy, Biomarker
Medical subject headings
Cholangiocarcinoma, Biliary Tract Neoplasms

What participants receive

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

  • LenvatinibDrug

    Also called E7080, Lenvima

    Drug doses for BTC are identical, being orally administered at 8mg/d to patients weighing <60 kg and 12mg/d to those ≥60 kg.

Study groups in NCT04656249
Study groupRoleWhat they receive
LenvatinibExperimentalDrug doses for BTC are identical, being orally administered at 8mg/d to patients weighing <60 kg and 12mg/d to those ≥60 kg.
Receives: Drug: Lenvatinib

What is being measured

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

  1. Objective Response Rate (ORR)

    Objective response rate

    Measured: Six months

  2. Progression free survival (PFS)

    Progression free survival

    Measured: Six months

Secondary outcomes (3)

  1. Overall survival (OS)

    Overall survival (OS) [ Time Frame: From the date of first dose of study drug to the date of death from any cause, or up to approximately 2 years ]

    Measured: Two years

  2. Disease control rate (DCR)

    DCR is defined as the percentage of participants with complete response (CR) + partial response (PR) + stable disease (SD).

    Measured: Six months

  3. The Rate of Treatment Related Adverse Events

    Treatment related adverse events (AEs) were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (CTCAE 4.0). The study recorded the occurrence rate of treatment related AEs

    Measured: Three years

Timeline

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

  1. First posted7 Dec 2020
  2. Study start1 Jan 2018
  3. Primary completion1 Dec 2020
  4. Study completion1 May 2021

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
Model description
Patients are confirmed with biliary tract cancers by imaging and histological examination and meet with the inclusive criteria, including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, common bile duct cancer and gallbladder cancer.
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04656249
Sponsor's protocol ID
PUMCH-JS-1391
Acronym
LENABC
Status last verified
Nov 2020
First submitted
30 Nov 2020
Last updated
4 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, Baron A, Park JW, Han G, Jassem J, Blanc JF, Vogel A, Komov D, Evans TRJ, Lopez C, Dutcus C, Guo M, Saito K, Kraljevic S, Tamai T, Ren M, Cheng AL. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163-1173. doi: 10.1016/S0140-6736(18)30207-1.

    PubMed 29433850

  • Marquardt JU, Saborowski A, Czauderna C, Vogel A. The Changing Landscape of Systemic Treatment of Advanced Hepatocellular Carcinoma: New Targeted Agents and Immunotherapies. Target Oncol. 2019 Apr;14(2):115-123. doi: 10.1007/s11523-019-00624-w.

    PubMed 30805831

  • Obi S, Sato T, Sato S, Kanda M, Tokudome Y, Kojima Y, Suzuki Y, Hosoda K, Kawai T, Kondo Y, Isomura Y, Ohyama H, Nakagomi K, Ashizawa H, Miura Y, Amano H, Mochizuki H, Omata M. The efficacy and safety of lenvatinib for advanced hepatocellular carcinoma in a real-world setting. Hepatol Int. 2019 Mar;13(2):199-204. doi: 10.1007/s12072-019-09929-4. Epub 2019 Jan 22.

    PubMed 30671808

  • Hiraoka A, Kumada T, Kariyama K, Takaguchi K, Atsukawa M, Itobayashi E, Tsuji K, Tajiri K, Hirooka M, Shimada N, Shibata H, Ishikawa T, Ochi H, Tada T, Toyoda H, Nouso K, Tsutsui A, Itokawa N, Imai M, Joko K, Hiasa Y, Michitaka K; Real-life Practice Experts for HCC (RELPEC) Study Group, HCC 48 Group (hepatocellular carcinoma experts from 48 clinics in Japan). Clinical features of lenvatinib for unresectable hepatocellular carcinoma in real-world conditions: Multicenter analysis. Cancer Med. 2019 Jan;8(1):137-146. doi: 10.1002/cam4.1909. Epub 2018 Dec 21.

    PubMed 30575325

  • El-Serag HB. Epidemiology of viral hepatitis and hepatocellular carcinoma. Gastroenterology. 2012 May;142(6):1264-1273.e1. doi: 10.1053/j.gastro.2011.12.061.

    PubMed 22537432

  • Zhang B, Zhang B, Zhang Z, Huang Z, Chen Y, Chen M, Bie P, Peng B, Wu L, Wang Z, Li B, Fan J, Qin L, Chen P, Liu J, Tang Z, Niu J, Yin X, Li D, He S, Jiang B, Mao Y, Zhou W, Chen X. 42,573 cases of hepatectomy in China: a multicenter retrospective investigation. Sci China Life Sci. 2018 Jun;61(6):660-670. doi: 10.1007/s11427-017-9259-9. Epub 2018 Feb 2.

    PubMed 29417360

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

  • Witjes CD, Karim-Kos HE, Visser O, de Vries E, IJzermans JN, de Man RA, Coebergh JW, Verhoef C. Intrahepatic cholangiocarcinoma in a low endemic area: rising incidence and improved survival. HPB (Oxford). 2012 Nov;14(11):777-81. doi: 10.1111/j.1477-2574.2012.00536.x. Epub 2012 Aug 17.

    PubMed 23043667

  • Bridgewater J, Galle PR, Khan SA, Llovet JM, Park JW, Patel T, Pawlik TM, Gores GJ. Guidelines for the diagnosis and management of intrahepatic cholangiocarcinoma. J Hepatol. 2014 Jun;60(6):1268-89. doi: 10.1016/j.jhep.2014.01.021. Epub 2014 Mar 27. No abstract available.

    PubMed 24681130

  • Ueno M, Ikeda M, Sasaki T, Nagashima F, Mizuno N, Shimizu S, Ikezawa H, Hayata N, Nakajima R, Morizane C. Phase 2 study of lenvatinib monotherapy as second-line treatment in unresectable biliary tract cancer: primary analysis results. BMC Cancer. 2020 Nov 16;20(1):1105. doi: 10.1186/s12885-020-07365-4.

    PubMed 33198671

  • Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

    PubMed 19097774

  • Zhou J, Sun HC, Wang Z, Cong WM, Wang JH, Zeng MS, Yang JM, Bie P, Liu LX, Wen TF, Han GH, Wang MQ, Liu RB, Lu LG, Ren ZG, Chen MS, Zeng ZC, Liang P, Liang CH, Chen M, Yan FH, Wang WP, Ji Y, Cheng WW, Dai CL, Jia WD, Li YM, Li YX, Liang J, Liu TS, Lv GY, Mao YL, Ren WX, Shi HC, Wang WT, Wang XY, Xing BC, Xu JM, Yang JY, Yang YF, Ye SL, Yin ZY, Zhang BH, Zhang SJ, Zhou WP, Zhu JY, Liu R, Shi YH, Xiao YS, Dai Z, Teng GJ, Cai JQ, Wang WL, Dong JH, Li Q, Shen F, Qin SK, Fan J. Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2017 Edition). Liver Cancer. 2018 Sep;7(3):235-260. doi: 10.1159/000488035. Epub 2018 Jun 14.

    PubMed 30319983

  • Ji X, Bu ZD, Yan Y, Li ZY, Wu AW, Zhang LH, Zhang J, Wu XJ, Zong XL, Li SX, Shan F, Jia ZY, Ji JF. The 8th edition of the American Joint Committee on Cancer tumor-node-metastasis staging system for gastric cancer is superior to the 7th edition: results from a Chinese mono-institutional study of 1663 patients. Gastric Cancer. 2018 Jul;21(4):643-652. doi: 10.1007/s10120-017-0779-5. Epub 2017 Nov 22.

    PubMed 29168120

  • Al-Salama ZT, Syed YY, Scott LJ. Lenvatinib: A Review in Hepatocellular Carcinoma. Drugs. 2019 Apr;79(6):665-674. doi: 10.1007/s40265-019-01116-x.

    PubMed 30993651

  • Zhu RX, Seto WK, Lai CL, Yuen MF. Epidemiology of Hepatocellular Carcinoma in the Asia-Pacific Region. Gut Liver. 2016 May 23;10(3):332-9. doi: 10.5009/gnl15257.

    PubMed 27114433

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenvatinib in people with Cholangiocarcinoma and Biliary Tract Cancer, run by Peking Union Medical College Hospital 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 14 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 4 Jun 2021. 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 Response Rate (ORR) (time frame: Six months). The study lists 2 primary outcomes in all. 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 NCT04656249, which also lists 22 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 4 Jun 2021.

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