A Study of Atezolizumab in Patients With Unresectable, Locally Advanced or Metastatic NSCLC (J-TAIL)

An observational study of Non-small-Cell Lung Cancer, run by Chugai Pharmaceutical at 198 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This prospective, observational study is to assess the long-term effectiveness and safety of Atezolizumab in patients with advanced non-small cell lung cancer in clinical practice. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Non-small-Cell Lung Cancer
How many people: 1,026 participants
Where: 198 sitesJapan
Study dates: 15 Aug 2018to 8 Jul 2021
Phase: Observational
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients who are planning to provide Atezolizumab monotherapy as the most appropriate medical care for patients and who meet the Eligibility criteria at registration.

Who may be able to join

Patients 20 years of age or older at the time of signed consent.
Patients with locally advanced or metastatic non-small cell lung cancer.
Patients who are scheduled to start Atezolizumab monotherapy, based on the Atezolizumab package insert and the Optimal Use Promotion Guideline.
Patients who signed informed consent form before enrolling the study. The consent from a legally acceptable representative is required for the patients with uncertain capacity of judgments.

Who cannot join

Patients who are considered to be unsuitable for enrolment into the study by the investigator's judgment.

Trial locations and contacts

198 sites in 1 country.

City, postcode or hospital

198 sites in 1 country

Japan198 sites

Akashi Medical Center
Akashi
Hyogo Cancer Center
Akashi
Akita University Hospital
Akita
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki
Aomori Prefectural Central Hospital
Aomori
Asahikawa Medical University Hospital
Asahikawa
National Hospital Organization Asahikawa Medical Center
Asahikawa
Juntendo University Hospital
Bunkyō City
Nippon Medical School Hospital
Bunkyō City
Tokyo Medical And Dental University, Medical Hospital
Bunkyō City
Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital
Bunkyō City
Chiba Cancer Center
Chiba
Chiba University Hospital
Chiba
National Cancer Center Hospital
Chūōku
Fujisawa City Hospital
Fujisawa
Fukui Prefectural Hospital
Fukui
Fukuoka University Hospital
Fukuoka
Kyushu University Hospital
Fukuoka
National Hospital Organization Kyushu Cancer Center
Fukuoka
National Hospital Organization Kyushu Medical Center
Fukuoka
Fukushima Medical University Hospital
Fukushima
Funabashi Municipal Medical Center
Funabashi
Gifu Prefectural General Medical Center
Gifu
Gifu University Hospital
Gifu
National Hospital Organization Okinawa National Hospital
Ginowan
Osaka Habikino Medical Center
Habikino
Hamamatsu University Hospital
Hamamatsu
National Hospital Organization Himeji Medical Center
Himeji
Hirosaki University Hospital
Hirosaki
National Hospital Organization Hirosaki National Hospital
Hirosaki
Hiroshima City Hiroshima Citizens Hospital
Hiroshima
Hiroshima Prefectural Hospital
Hiroshima
Hiroshima University Hospital
Hiroshima
Tokyo Medical University Ibaraki Medical Center
Ibaraki
Iizuka Hospital
Iizuka
Nippon Medical School Chiba Hokusoh Hospital
Inzai
Japanese Red Cross Ise Hospital
Ise
Tokai University Hospital
Isehara
Isesaki Municipal Hospital
Isesaki
Itami City Hospital
Itami
National Hospital Organization Iwakuni Clinical Center
Iwakuni
Shimane University Hospital
Izumo
Juntendo University Shizuoka Hospital
Izunokuni
Kagawa University Hospital
Kagawa
Kagoshima University Hospital
Kagoshima
Kameda Medical Center
Kamogawa
Ishikawa Prefectural Central Hospital
Kanazawa
Kanazawa University Hospital
Kanazawa
Ibaraki Prefectural Central Hospital
Kasama
Kasukabe Medical Center
Kasukabe
Kanto Rosai Hospital
Kawasaki
Kawasaki Municipal Hospital
Kawasaki
Kimitsu Chuo Hospital
Kisarazu
Kishiwada City Hospital
Kishiwada
Hospital of the University of Occupational and Envioronmental Health, Japan
Kitakyushu
Japan Community Health care Organization Kyushu Hospital
Kitakyushu
Kitakyushu Municipal Medical Center
Kitakyushu
Fukujuji Hospital
Kiyose
National Hospital Organization Tokyo National Hospital
Kiyose
Kobe City Medical Center General Hospital
Kobe
Kobe Minimally Invasive Cancer Center
Kobe
Kobe University Hospital
Kobe
Yamanashi Prefectural Central Hospital
Kofu
Komatsu Municipal Hospital
Komatsu
Ohta Nishinouchi Hospital
Kōriyama
Dokkyo Medical University Saitama Medical Center
Koshigaya
Cancer Institute Hospital of Japanese Foundation For Cancer Research
Kōtoku
Kumamoto Regional Medical Center
Kumamoto
Kumamoto University Hospital
Kumamoto
Kurashiki Central Hospital
Kurashiki
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Kure
Kurume University Hospital
Kurume
Japanese Red Cross Kyoto Daiichi Hospital
Kyoto
Japanese Red Cross Kyoto Daini Hospital
Kyoto
Kyoto City Hospital
Kyoto
Kyoto University Hospital
Kyoto
Kyoto-Katsura Hospital
Kyoto
National Hospital Organization Kyoto Medical Center
Kyoto
University Hospital, Kyoto Prefectural University of Medicine
Kyoto
Gunma University Hospital
Maebashi
Shinshu University Hospital
Matsumoto
Matsusaka Municipal Hospital
Matsusaka
Ehime Prefectural Central Hospital
Matsuyama
Matsuyama Red Cross Hospital
Matsuyama
National Hospital Organization Shikoku Cancer Center
Matsuyama
National Hospital Organization Tokyo Medical Center
Meguro City
The Jikei University Hospital
Minatoku
Tokyo Saiseikai Central Hospital
Minatoku
Toranomon Hospital
Minatoku
Kyorin University Hospital
Mitaka
Miyazaki Prefectural Miyazaki Hospital
Miyazaki
Iwate Prefectural Central Hospital
Morioka
Shiga General Hospital
Moriyama
Nagahama City Hospital
Nagahama
Aichi Medical University Hospital
Nagakute
Japanese Red Cross Society Nagano Hospital
Nagano
Nagaoka Red Cross Hospital
Nagaoka
Nagasaki University Hospital
Nagasaki
Aichi Cancer Center
Nagoya
Japanese Red Cross Nagoya Daini Hospital
Nagoya
Nagoya City West Medical Center
Nagoya
Nagoya Ekisaikai Hospital
Nagoya
Nagoya University Hospital
Nagoya
National Hospital Organization Nagoya Medical Center
Nagoya
Kochi Medical School Hospital
Nankoku
Nara Prefecture General Medical Center
Nara
Miyagi Cancer Center
Natori
Niigata Cancer Center Hospital
Niigata
Niigata University Medical and Dental Hospital
Niigata
The Hospital of Hyogo College of Medicine
Nishinomiya
Obihiro Kosei Hospital
Obihiro
Ogaki Municipal Hospital
Ōgaki
Oita Prefectural Hospital
Ōita
Japanese Red Cross Okayama Hospital
Okayama
Kawasaki Medical School General Medical Center
Okayama
Okayama Rosai Hospital
Okayama
Okayama University Hospital
Okayama
University of Ryukyus Hospital
Okinawa
Kitano Hospital
Osaka
Osaka City General Hospital
Osaka
Osaka City University Hospital
Osaka
Osaka General Medical Center
Osaka
Osaka International Cancer Institute
Osaka
Osaka Medical College Hospital
Osaka
Osaka Police Hospital
Osaka
Osaka Red Cross Hospital
Osaka
Osaka Saiseikai Nakatsu Hospital
Osaka
Kindai University Hospital
Ōsaka-sayama
Osaki Citizen Hospital
Ōsaki
Gunma Prefectural Cancer Center
Ōta-ku
Shiga University of Medical Science Hospital
Ōtsu
Saga University Hospital
Saga
Kitasato University Hospital
Sagamihara
Jichi Medical University Saitama Medical Center
Saitama
Saitama Cancer Center
Saitama
Saitama Medical University Hospital
Saitama
Saitama medical university International medical Center
Saitama
Saitama Red Cross Hospital
Saitama
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai
Nihonkai General Hospital
Sakata
Hokkaido Cancer Center
Sapporo
Hokkaido University Hospital
Sapporo
Japan Community Health care Organization Hokkaido Hospital
Sapporo
Sapporo Medical University Hospital
Sapporo
Teine Keijinkai Hospital
Sapporo
Sendai Medical Association Hospital
Sendai
Sendai Kousei Hospital
Sendai
Tohoku Medical And Pharmaceutical University Hospital
Sendai
Tohoku University Hospital
Sendai
Tosei General Hospital
Seto
Japanese Red Cross Medical Center
Shibuya City
Jichi Medical University Hospital
Shimotsuke
NTT Medical Center Tokyo
Shinagawa-Ku
Showa University Hospital
Shinagawa-Ku
Center Hospital of the National Center for Global
Shinjuku-Ku
Keio University Hospital
Shinjuku-Ku
Tokyo Medical University Hospital
Shinjuku-Ku
Tokyo Women's Medical University Hospital
Shinjuku-Ku
Iwate Medical University Hospital
Shiwa-gun
Shizuoka Cancer Center
Shizuoka
Shizuoka General Hospital
Shizuoka
Osaka University Hospital
Suita
Saiseikai Suita Hospital
Suita
Gifu Prefectural Tajimi Hospital
Tajimi
Kagawa Prefectural Central Hospital
Takamatsu
KKR Takamatsu Hospital
Takamatsu
JA Toyama Kouseiren Takaoka Hospital
Takaoka
Takarazuka City Hospital
Takarazuka
Tenri Hospital
Tenri
Dokkyo Medical University Hospital
Tochigi
Tokushima Prefectural Central Hospital
Tokushima
Tokushima University Hospital
Tokushima
Ehime University Hospital
Tōon
Toyama Prefectural Central Hospital
Toyama
Fujita Health University Hospital
Toyoake
Toyohashi Municipal Hospital
Toyohashi
Osaka Toneyama Medical Center
Toyonaka
TOYOTA Memorial Hospital
Toyota
Mie University Hospital
Tsu
Tsukuba Medical Center Foundation
Tsukuba
University of Tsukuba Hospital
Tsukuba
National Hospital Organization Yamaguchi-Ube Medical Center
Ube
Uji-TOKUSHUKAI MEDICAL CENTER
Uji
Juntendo University Urayasu Hospital
Urayasu
Saiseikai Utsunomiya Hospital
Utsunomiya
Tochigi Cancer Center
Utsunomiya
Japanese Red Cross Wakayama Medical Center
Wakayama
Wakayama Medical University Hospital
Wakayama
Yamagata University Hospital
Yamagata
Yamaguchi University Hospital
Yamaguchi
Kanagawa Cancer Center
Yokohama
Kanagawa Cardiovascular and Respiratory Center
Yokohama
Yokohama City University Hospital
Yokohama
Yokohama City University Medical Center
Yokohama
Yokohama Municipal Citizen's Hospital
Yokohama
Yokosuka Kyosai Hospital
Yokosuka
Tottori University Hospital
Yonago
Oita University hospital
Yufu

Other trials in Japan

About this study

Official title: Prospective Multicenter Observational Study of Atezolizumab in Patients With Unresectable, Locally Advanced or Metastatic Non-small Cell Lung Cancer: (J-TAIL)

This prospective, observational study is to assess the long-term effectiveness and safety of Atezolizumab in patients with advanced non-small cell lung cancer in clinical practice.

Read the detailed description

Primary endpoint: 18 months OS, Secondary endpoints: Overall Survival(OS), 12 months survival rate(12mo OS), 24 months survival rate(24mo OS), Progression-Free Survival(PFS), Time to treatment failure (TTF), Objective Response Rate(ORR), Disease Control Rate(DCR), Duration of Response(DOR) ,Safety and EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire

Conditions: Non-small-Cell Lung Cancer
Keywords: Atezolizumab
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What is being measured

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

18 months survival rate
Percentage of participants alive 18 months after initiation of treatment
Measured: Baseline up to 18 Months

Secondary outcomes (10)

Overall Survival(OS)
OS was defined as the time from the first day of study treatment to death due to any cause
Measured: Up to death (up to 4 years)
12 months survival rate
Percentage of participants alive 12 months after initiation of treatment
Measured: Up to 12 months
24 months survival rate
Percentage of participants alive 24 months after initiation of treatment
Measured: Up to 24 months
Progression-Free Survival(PFS)
PFS based on disease status as evaluated by the investigator in accordance with Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v1.1)
Measured: Up to disease progression or death whichever occurs first (up to 4 years)
Time to treatment failure (TTF)
TTF was defined as the time from the first day of study treatment to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death
Measured: Up to 4 years
Objective Response Rate(ORR)
Percentage of participants with objective response as assessed by the investigator according to RECIST v1.1
Measured: Up to disease progression or death whichever occurs first (up to 4 years)
Disease Control Rate(DCR)
Percentage of patients with controled disease as Assessed by the investigator according to RECIST v1.1
Measured: Up to 4 years
Duration of Response(DOR)
Duration of Response as Assessed by the Investigator According to RECIST v1.1
Measured: From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)
Percentage of Participants with adverse events(Adverse Reactions)
The incidence of worst-grade adverse events on study as graded by NCI-CTCAE v4.0
Measured: Up to 4 years
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
EQ-5D-5L consists of five standardized questions. Evaluate the quality of life by converting the result obtained into scores (range: 1.000 to - 0.025). Higher values give better results.
Measured: Day 1 of first cycle(21-day cycle), then every 12 weeks until disease progression or until treatment discontinuation(Up to 4 years)

Timeline

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

15 Aug 20188 Jul 2021

First posted24 Aug 2018
Study start15 Aug 2018
Primary completion8 Jul 2021
Study completion8 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Non-small-Cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,026 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03645330
Sponsor's protocol ID: J-TAIL
Status last verified: Jul 2022
First submitted: 19 Aug 2018
Last updated: 22 Jul 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All IPD that underlie results in a publication

Publications

Mouri A, Kagamu H, Tamada K, Nishio M, Akamatsu H, Goto Y, Hayashi H, Miura S, Gemma A, Yoshino I, Misumi T, Saito R, Yanagitani N, Masaki F, Nokihara H, Nishino K, Seike M, Hase T, Hataji O, Takeoka H, Kawashima Y, Kuroki H, Sugimoto M, Kuriki H, Mitsudomi T. Analysis of Peripheral T Cell Profiling and Plasma Proteomics in Advanced NSCLC Patients Treated With Atezolizumab. Cancer Sci. 2026 Apr;117(4):904-916. doi: 10.1111/cas.70310. Epub 2026 Feb 2.
PubMed 41627979

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

All Non-small-Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Multicenter Observational Study of Atezolizumab in Patients With Unresectable, Locally Advanced or Metastatic Non-small Cell Lung Cancer: (J-TAIL)
ClinicalTrials.gov ID: NCT03645330
Acronym / sponsor ID: J-TAIL
Conditions: Non-small-Cell Lung Cancer
Keywords: Atezolizumab
Study type: Observational
Recruitment status: Completed
Enrolment: 1,026 participants (actual)
Lead sponsor: Chugai PharmaceuticalIndustry (pharma, biotech, devices)
Collaborators: Japan Lung Cancer Society
Study start: 15 Aug 2018 (actual)
Primary completion: 8 Jul 2021 (actual)
Study completion: 8 Jul 2021 (actual)
First posted: 24 Aug 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This prospective, observational study is to assess the long-term effectiveness and safety of Atezolizumab in patients with advanced non-small cell lung cancer in clinical practice.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients who are planning to provide Atezolizumab monotherapy as the most appropriate medical care for patients and who meet the Eligibility criteria at registration.

Key inclusion criteria (4 listed)

Patients 20 years of age or older at the time of signed consent.
Patients with locally advanced or metastatic non-small cell lung cancer.
Patients who are scheduled to start Atezolizumab monotherapy, based on the Atezolizumab package insert and the Optimal Use Promotion Guideline.
Patients who signed informed consent form before enrolling the study. The consent from a legally acceptable representative is required for the patients with uncertain capacity of judgments.

Key exclusion criteria (1 listed)

Patients who are considered to be unsuitable for enrolment into the study by the investigator's judgment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

18 months survival rate
Time frame: Baseline up to 18 Months
Percentage of participants alive 18 months after initiation of treatment

10 secondary outcomes

Overall Survival(OS)
Time frame: Up to death (up to 4 years)
12 months survival rate
Time frame: Up to 12 months
24 months survival rate
Time frame: Up to 24 months
Progression-Free Survival(PFS)
Time frame: Up to disease progression or death whichever occurs first (up to 4 years)
Time to treatment failure (TTF)
Time frame: Up to 4 years
Objective Response Rate(ORR)
Time frame: Up to disease progression or death whichever occurs first (up to 4 years)
Disease Control Rate(DCR)
Time frame: Up to 4 years
Duration of Response(DOR)
Time frame: From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)
Percentage of Participants with adverse events(Adverse Reactions)
Time frame: Up to 4 years
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
Time frame: Day 1 of first cycle(21-day cycle), then every 12 weeks until disease progression or until treatment discontinuation(Up to 4 years)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
Derived from this study: PubMed 41627979Mouri A, Kagamu H, Tamada K, Nishio M, Akamatsu H, Goto Y, Hayashi H, Miura S, Gemma A, Yoshino I, Misumi T, Saito R, Yanagitani N, Masaki F, Nokihara H, Nishino K, Seike M, Hase T, Hataji O, Takeoka H, Kawashima Y, Kuroki H, Sugimoto M, Kuriki H, Mitsudomi T. Analysis of Peripheral T Cell Profiling and Plasma Proteomics in Advanced NSCLC Patients Treated With Atezolizumab. Cancer Sci. 2026 Apr;117(4):904-916. doi: 10.1111/cas.70310. Epub 2026 Feb 2.
Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication

Related trials for Non-small-Cell Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tetsuya MITSUDOMI, MD/PhD principal investigator

Kindai University Faculty of Medicine

198 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Non-small-Cell Lung Cancer, run by Chugai Pharmaceutical at 198 sites in Japan.

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 4 inclusion and 1 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 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 198 sites in Japan. 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.

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?

18 months survival rate (time frame: Baseline up to 18 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 NCT03645330, 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 22 Jul 2022.