ClinicalTrials.gg
CompletedNCT03321630Updated Mar 27, 2024Results posted

A Phase II a Study of Lenvatinib, a Multi-targeted Tyrosine Kinase Inhibitor, Combined With Pembrolizumab (PD-1 Inhibitor) for the Treatment of Metastatic Gastroesophageal Cancer Patients Who Have Progressed on First or Subsequent Line Therapies

A Phase 2 interventional study of Lenvatinib and Pembrolizumab in GastroEsophageal Cancer and Gastric Cancer, sponsored by NYU Langone Health. Completed at 2 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-03-27.

Sponsored by NYU Langone Health · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 15 studies testing lenvatinib in Stomach Neoplasms — 9 open to participants now, 11 under way, none of them phase 3. lenvatinib · Stomach Neoplasms.

Enrollment
12th of 15
24 · median 42
Started
2017
the only one that year
Phase 2
10 of 15
6 open now
Registered
1st of 15
by date
Lead sponsor
1 of 15
NYU Langone Health

Among the 15 studies testing lenvatinib in Stomach Neoplasms, this one is the 12th largest by enrollment, is the only one that started in 2017, is one of 10 in phase 2, and was the 1st registered.

Stomach Neoplasms

3,401 studies on the registry are indexed under Stomach Neoplasms; 993 are open to participants now.

Browse Stomach Neoplasms studies →

Open to participants now

9 of the 15 studies testing lenvatinib in Stomach Neoplasms are open now, in 3 countries. Recruiting first, the newest first:

4 more — sign in →

By country, each count listing its studies:

All 9 open studies →

About lenvatinib

lenvatinib: first FDA approval 2015 (LENVIMA), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 704 Stomach Neoplasms studies recruiting now, 376 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 69 take healthy volunteers.

This study: 18 Years to 100 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 15 studies testing lenvatinib in Stomach Neoplasms, or all of them as a file.
02

Study summary

This is an open label, single arm phase II study, to determine the overall response rate for the combination of lenvatinib and pemrolizumab in patients with metastatic gastroesophageal cancer who have progressed on first or subsequent line therapies. Given the significant cross talk between angiogenesis and the immune response, combined therapy with lenvatinib and pemrolizumab in advanced gastroesophageal cancer patient will provide improved outcomes compared to standard treatment with currently approved agents.

Read the detailed description

The objective of this study is to determine the progression free survival (PFS), overall survival (OS) and toxicity rates in advanced gastroesophageal patients treated with lenvatinib and pemrolizumab.

03

Conditions studied

  • GastroEsophageal Cancer
  • Gastric Cancer

Browse trials for

Keywords

  • Pebrolizumab
  • Lenvatinib
04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Be willing and able to provide written /assent for the trial.
  • Be greater than 18 years of age on day of signing informed consent.
  • Have or cytologically confirmed or recurrent gastric or GEJ adenocarcinoma.
  • Have based on 1.1.
  • Must have received and have progressed, or are intolerant to at least one systemic regimen (platinum- or fluoropyrimidine-based chemotherapy regimen for metastatic or recurrent disease.)
  • If Her2 positive, must have received and have progressed or are intolerant to treatment with trastuzumab for metastatic or recurrent disease.
  • Subjects must consent to provide (initial and subsequent tumor biopsy samples, if possible) for correlative biomarker studies.
  • Have a performance status of 0 or 1 on the Performance Scale.
  • Adequately controlled blood pressure with or without antihypertensive medications defined as BP \< 140/90 mmHg at screening and no change in antihypertensive mediation within 1 week prior to the Screening Visit.
  • Demonstrate adequate organ function as defined in Table 5, all screening labs should be performed within 10 days of treatment initiation.
  • Female subject of should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female subjects of childbearing potential (Section 5.5.2) must be willing to use an adequate method of as outlined in Section 5.5.2 - Contraception, for the course of the study through 120 days after the last dose of study medication.
  • Male subjects of childbearing potential (Section 5.5.2) must agree to use an adequate method of contraception as outlined in Section 5.5.2 - Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.

Exclusion criteria

Exclusion Criteria:

  • Is currently participating and receiving study therapy or has participated in a study of an agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  • Has a diagnosis of immunodeficiency or is receiving systemic therapy (in dosing exceeding 10mg daily of prednisone equivalent) or any other form of therapy within 7 days prior to the first dose of trial treatment.
  • Has a known history of active TB (Bacillus Tuberculosis)
  • to pembrolizumab or lenvatinib or any of its .
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  • Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
  • Note: If subject received major surgery, a minimum of four weeks must have passed and they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • Has a known additional that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Subjects having >1+ proteinuria on urine dipstick testing will undergo 24h urine collection for quantitative assessment of proteinuria. Subjects with urine protein >1g/24h will be ineligible.
  • Gastrointestinal malabsorption or any other condition in the opinion of the investigator that might affect the absorption of lenvatinib.
  • Prolongation of interval to >480ms
  • Significant cardiovascular impairment: history of congestive heart failure greater than (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug.
  • Bleeding disorders or active significant bleeding (i.e. hemoptysis, hematochezia, hematemesis) within 3 weeks.
  • Thrombotic disorders or use of anticoagulants, such as warfarin, requiring therapeutic (INR) monitoring. (treatment with low molecular weight heparin (LMWH) or direct acting oral anti-coagulants is allowed.)
  • History of prior gastrointestinal fistula and/or perforation.
  • Has known active central nervous system (CNS) and/or carcinomatous meningitis. Subjects with previously treated may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  • Has active disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
  • Has known history of, or any evidence of active, non-infectious pneumonitis.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
  • Has received prior therapy with an , anti-PD-L1, or anti-PD-L2 agent.
  • Has a known history of (HIV) (HIV 1/2 antibodies).
  • Has known active (e.g., HBsAg reactive) or (e.g., HCV RNA [qualitative] is detected).
  • Has received a within 30 days of planned start of study therapy.
  • Arrhythmias requiring Class Ia and III antiarrhythmics and/or grade >2 bradycardia.
Terms in these criteria, in plain language(25)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Other
    Lenvatinib & Pembrolizumab

    Drug: Lenvatinib · Drug: Pembrolizumab

Interventions

  • Lenvatinib 20 mg orally each day on days 1-7

  • Pembrolizumab 200mg intravenously, to be initiated on day 8, and continued every 3 weeks, in combination with daily lenvatinib 20 mg

06

What researchers measure

Primary outcomes

  1. Overall Response Rate

    Overall response rate as measured by RECIST 1.1; percentage of participants who experience a best overall response of either Complete Response (CR) or Partial Response (PR).

    Time frame: Up to Month 18

  2. Overall Survival (OS)

    Estimated using Kaplan-Meier curve; interval from start of treatment to death due to any cause.

    Time frame: Up to Month 18

  3. Progression-Free Survival (PFS)

    Estimated using Kaplan-Meier Curves; interval between the date of start of treatment and the earlier date of objective disease progression per RECIST 1.1 criteria or death due to any cause in the absence of progression.

    Time frame: Up to Month 18

07

Results

Posted Mar 27, 2024

Participant flow

Participant flow — Overall Study
MilestoneLenvatinib & Pembrolizumab
Started24
Completed20
Not completed4
Withdrew: Adverse event1
Withdrew: Investigator discretion2
Withdrew: Withdrawal by subject1

Outcome measures

PrimaryOverall Response Rate

Overall response rate as measured by RECIST 1.1; percentage of participants who experience a best overall response of either Complete Response (CR) or Partial Response (PR).

Time frame:
Up to Month 18
Reported as:
Number · percentage of participants
Overall Response Rate
percentage of participantsLenvatinib & Pembrolizumab
Overall Response Rate25 (8.7 to 49)
PrimaryOverall Survival (OS)

Estimated using Kaplan-Meier curve; interval from start of treatment to death due to any cause.

Time frame:
Up to Month 18
Reported as:
Median · weeks
Overall Survival (OS)
weeksLenvatinib & Pembrolizumab
Overall Survival (OS)21.4 (15.7 to 74.0)
PrimaryProgression-Free Survival (PFS)

Estimated using Kaplan-Meier Curves; interval between the date of start of treatment and the earlier date of objective disease progression per RECIST 1.1 criteria or death due to any cause in the absence of progression.

Time frame:
Up to Month 18
Reported as:
Median · weeks
Progression-Free Survival (PFS)
weeksLenvatinib & Pembrolizumab
Progression-Free Survival (PFS)12.9 (8.6 to 41.3)

Adverse events

Collected over 18 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lenvatinib & Pembrolizumab18/24 (75%)14/24 (58.3%)18/24 (75%)
Most frequent serious events
Showing 10 of 18
Most frequent serious events
EventLenvatinib & Pembrolizumab
Abdominal PainGastrointestinal disorders13/24
AnorexiaMetabolism and nutrition disorders10/24
VomitingGastrointestinal disorders10/24
Alkaline Phosphatase IncreasedInvestigations9/24
Back PainMusculoskeletal and connective tissue disorders7/24
Blood Bilirubin IncreasedInvestigations5/24
Small Intestinal ObstructionGastrointestinal disorders3/24
ConfusionPsychiatric disorders2/24
Death NosGeneral disorders2/24
DehydrationMetabolism and nutrition disorders2/24
Most frequent other events
Showing 10 of 178
Most frequent other events
EventLenvatinib & Pembrolizumab
Lymphocyte Count DecreasedInvestigations15/24
NauseaGeneral disorders14/24
ConstipationGastrointestinal disorders13/24
FatigueGeneral disorders13/24
AnemiaBlood and lymphatic system disorders12/24
HypoalbuminemiaMetabolism and nutrition disorders12/24
HyponatremiaMetabolism and nutrition disorders12/24
White Blood Cell Count DecreasedInvestigations12/24
Platelet Count DecreasedInvestigations10/24
Aspartate Aminotransferase IncreasedInvestigations8/24

Baseline characteristics

Age, Continuous
Age, Continuous(years)Lenvatinib & Pembrolizumab
Median62 (27 to 73)
Sex: Female, Male
Sex: Female, Male(Participants)Lenvatinib & Pembrolizumab
Female4
Male16
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Lenvatinib & Pembrolizumab
Hispanic or Latino4
Not Hispanic or Latino16
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Lenvatinib & Pembrolizumab
American Indian or Alaska Native1
Asian3
Native Hawaiian or Other Pacific Islander1
Black or African American2
White13
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Lenvatinib & Pembrolizumab
United States20
08

Study locations

2 sites
  • NYU Langone Health
    New York, New York 10016, United States
  • The Mount Sinai Hospital
    New York, New York 10029, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Mar 2023, 64 months.

Results were first posted in Mar 2024, 1 year after primary completion.

Of 295 non-industry phase 2 interventional studies under Stomach Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 76. This study's 64 months is above that.

Counting every sponsor, half of 360 studies reached it within 50 months; a quarter within 31 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2017
First posted
Oct 25, 2017
StartActual
Oct 24, 2017
Primary completionActual
Mar 10, 2023
CompletionActual
Jan 16, 2024
Results first posted
Mar 27, 2024
Last update
Mar 27, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03321630
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Oct 25, 2017
Start date
Oct 24, 2017
Primary completion
Mar 10, 2023
Completion
Jan 16, 2024
Results posted
Mar 27, 2024
Last update
Mar 27, 2024

Study contacts

Paul E. Oberstein, MD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Lenvatinib · Pembrolizumab

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