Hepatocellular Carcinoma (HCC)Phase 2NCT03419897
Study of BGB-A317 in Participants With Previously Treated Unresectable HCC
A Phase 2 study testing Tislelizumab in people with Hepatocellular Carcinoma (HCC), run by BeiGene at 54 sites in 8 countries.
Trial summary
This study investigated the efficacy, safety, and pharmacokinetics of the anti-PD-1 monoclonal antibody BGB-A317 in participants with previously treated hepatocellular unresectable carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 54 sitesin 8 countries
- Study dates
- 9 Apr 2018to 6 Jul 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically confirmed HCC
- Participants with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach
- Has received at least 1 line of systemic therapy for unresectable HCC
- Has at least 1 measurable lesion as defined per RECIST v1.1
- Child-Pugh score A
- Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Adequate organ function
Who cannot join
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
- Prior therapies targeting PD-1 or PD-L1
- Has known brain or leptomeningeal metastasis
- Tumor thrombus involving main trunk of portal vein or inferior vena cava
- Loco-regional therapy to the liver within 4 weeks before enrollment
- Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, or acute lung diseases
Show all 12Show fewer
- Has received:
- Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies
- Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Participant with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
54 sites in 8 countries.
54 sites in 8 countries
China25 sites
Military Hospital of China
Beijing, Beijing Municipality, 100039
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Chinese Pla General Hospital
Beijing, Beijing Municipality, 100853
Jilin Cancer Hospital
Changchun, Jilin, 130021
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong, 510245
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Zhejiang University College of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang, 310009
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
Anhui Provincial Hospital
Hefei, Anhui, 230000
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, 330006
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Weifang Peoples Hospital
Weifang, Shandong, 261000
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000
Henan Cancer Hospital
Zhengzhou, Henan, 450000
France9 sites
Hopital Beaujon
Clichy, 92210
Hopital de La Croix Rousse
Lyon, 69317
Chu Montpellier Hopital Saint Eloi
Montpellier, 34295
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes, 44093
Hopital Larchet Chu Nice
Nice, 6200
Groupe Hospitalier Du Haut Leveque
Pessac, 33604
Chu de Poitiers Site de La Mileterie
Poitiers, 86000
Centre Eugene Marquis
Rennes, 35043
Institut Gustave Roussy
Villejuif, 94805
Taiwan5 sites
E Da Hospital Kaohsiung
Kaohsiung City, 82445
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 10048
Taipei Veterans General Hospital
Taipei, 11217
Linkou Chang Gung Memorial Hospital
Taoyuan, 33305
United Kingdom5 sites
Queen Elizabeth Hospital
Birmingham, B15 2TH
The Christie Hospital
Greater Manchester, M20 4BX
Royal Free Hospital London Nhs Trust
London, NW3 2QG
Kings College
London, SE5 9RS
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Spain4 sites
Hospital Universitario Vall Dhebron
Barcelona, 08035
Ico Lhospitalet Hospital Duran I Reynals
Barcelona, 08908
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Hm Madrid Sanchinarro
Madrid, 28050
Germany3 sites
Kliniken Essen Mitte Evang Huyssens Stiftung
Essen, 45136
Universitatsklinikum Hamburg Eppendorf
Hamburg, 20251
Klinikum Johannes Gutenberg Universitaet Mainz
Mainz, 55131
Italy2 sites
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Istituto Clinico Humanitas
Rozzano, 20089
Poland1 site
Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy
Warsaw, 02-034
About this study
Official title: A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma
This study investigated the efficacy, safety, and pharmacokinetics of the anti-PD-1 monoclonal antibody BGB-A317 in participants with previously treated hepatocellular unresectable carcinoma.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Tislelizumab
- Keywords
- Advanced liver cancer, RATIONALE-208
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Also called BGB-A317
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab | Experimental | 200 milligrams once every 3 weeks Receives: Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) Assessed by Independent Review Committee (IRC)
ORR is defined as the percentage of participants with complete response (CR) and partial response (PR) as the best overall response, as determined by an IRC using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions.
Measured: From date of first dose to primary analysis data cut-off date of 30-June-2021 (up to approximately 3 years and 3 months)
Secondary outcomes (16)
ORR Assessed by Investigator
ORR is defined as the percentage of participants with CR and PR as the best overall response, as determined by investigator assessment using RECIST v1.1. CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions.
Measured: From date of first dose to end of study (up to approximately 4 years and 3 months)
Duration of Response (DOR) Assessed by IRC
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC using RECIST v1.1
Measured: From date of first dose to end of study (up to approximately 4 years and 3 months)
DOR Event-Free Rate Assessed by IRC
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC using RECIST v1.1. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for progression or death at 12 and 24 months with 95% confidence intervals estimated using Greenwood's formula.
Measured: From date of first dose to end of study (up to approximately 4 years and 3 months); Months 12 and 24 reported
DOR Assessed by Investigator
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the investigator using RECIST v1.1
Measured: From date of first dose to end of study (up to approximately 4 years and 3 months)
DOR Event-Free Rate Assessed by Investigator
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the investigator using RECIST v1.1. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for progression or death at 12 and 24 months with 95% confidence intervals estimated using Greenwood's formula.
Measured: From date of first dose to end of study (up to approximately 4 years and 3 months); Months 12 and 24 reported
Progression-free Survival (PFS) Assessed by IRC
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the IRC using RECIST v1.1
Measured: From date of first dose to end of study (up to approximately 4 years and 3 months)
PFS Assessed by Investigator
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the investigator using RECIST v1.1
Measured: From date of first dose to end of study (up to approximately 4 years and 3 months)
Overall Survival (OS)
OS is defined as the time from first study drug administration to the date of death due to any cause
Measured: From date of first dose to end of study (up to approximately 4 years and 3 months)
Disease Control Rate (DCR) Assessed by IRC
DCR is defined as the percentage of participants whose best overall response is CR, PR, or stable disease (SD) as assessed by the IRC using RECIST v1.1
Measured: From date of first dose to end of study (up to approximately 4 years and 3 months)
DCR Assessed by Investigator
DCR is defined as the percentage of participants whose best overall response is CR, PR, or stable disease (SD) as assessed by the investigator using RECIST v1.1
Measured: From date of first dose to end of study (up to approximately 4 years and 3 months)
Clinical Benefit Rate (CBR) Assessed by IRC
CBR is defined as the percentage of participants who have CR, PR, or SD of ≥ 24 weeks in duration as assessed by the IRC using RECIST v1.1
Measured: From date of first dose to end of study (up to approximately 4 years and 3 months)
CBR Assessed by Investigator
CBR is defined as the percentage of participants who have CR, PR, or SD of ≥ 24 weeks in duration as assessed by the investigator using RECIST v1.1
Measured: From date of first dose to end of study (up to approximately 4 years and 3 months)
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Visual Analogue Score (VAS)
Mean change from baseline in EQ-5D-5L VAS. The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.
Measured: Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status
Mean change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.
Measured: Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days)
EORTC QLQ - Hepatocellular Carcinoma 18 Questions (HCC18): Index Scores
Mean change from baseline in EORTC QLQ HCC18 Index Scores. The EORTC QLQ HCC18 is a specific questionnaire module that assesses quality of life of cancer patients related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.
Measured: Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days)
Number of Participants With Adverse Events
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs
Measured: From first dose up to 30 days after the last dose of study drug; up to approximately 4 years and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start9 Apr 2018
- Primary completion30 Jun 2021
- Study completion6 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419897
- Sponsor's protocol ID
- BGB-A317-208
- Other IDs
- 2017-003983-10, CTR20171257, 2017
- Status last verified
- Oct 2024
- First submitted
- 29 Jan 2018
- Last updated
- 26 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ren Z, Ducreux M, Abou-Alfa GK, Merle P, Fang W, Edeline J, Li Z, Wu L, Assenat E, Hu S, Rimassa L, Zhang T, Blanc JF, Pan H, Ross P, Yen CJ, Tran A, Shao G, Bouattour M, Chen Y, Meyer T, Hou J, Tougeron D, Bai Y, Hou MM, Meng Z, Wu J, Li V, Chica-Duque S, Cheng AL. Tislelizumab in Patients with Previously Treated Advanced Hepatocellular Carcinoma (RATIONALE-208): A Multicenter, Non-Randomized, Open-Label, Phase 2 Trial. Liver Cancer. 2022 Oct 4;12(1):72-84. doi: 10.1159/000527175. eCollection 2023 Feb.
PubMed 36872927Serrano D, Podger L, Barnes G, Song J, Tang B. Psychometric validation of the EORTC QLQ-HCC18 in patients with previously treated unresectable hepatocellular carcinoma. Qual Life Res. 2022 Mar;31(3):937-950. doi: 10.1007/s11136-021-02992-1. Epub 2021 Sep 13.
PubMed 34518988
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma
- ClinicalTrials.gov ID
- NCT03419897
- Acronym / sponsor ID
- BGB-A317-208
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Advanced liver cancer, RATIONALE-208
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Posted 27 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigated the efficacy, safety, and pharmacokinetics of the anti-PD-1 monoclonal antibody BGB-A317 in participants with previously treated hepatocellular unresectable carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab | Experimental | Drug: Tislelizumab200 milligrams once every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed HCC
- Participants with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach
- Has received at least 1 line of systemic therapy for unresectable HCC
- Has at least 1 measurable lesion as defined per RECIST v1.1
- Child-Pugh score A
Key exclusion criteria (12 listed)
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
- Prior therapies targeting PD-1 or PD-L1
- Has known brain or leptomeningeal metastasis
- Tumor thrombus involving main trunk of portal vein or inferior vena cava
- Loco-regional therapy to the liver within 4 weeks before enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TislelizumabAlso: BGB-A317Administered intravenously | Drug | Tislelizumab |
Primary outcome
Objective Response Rate (ORR) Assessed by Independent Review Committee (IRC)
Time frame: From date of first dose to primary analysis data cut-off date of 30-June-2021 (up to approximately 3 years and 3 months)
ORR is defined as the percentage of participants with complete response (CR) and partial response (PR) as the best overall response, as determined by an IRC using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions.
16 secondary outcomes
ORR Assessed by Investigator
Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months)
Duration of Response (DOR) Assessed by IRC
Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months)
DOR Event-Free Rate Assessed by IRC
Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months); Months 12 and 24 reported
DOR Assessed by Investigator
Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months)
DOR Event-Free Rate Assessed by Investigator
Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months); Months 12 and 24 reported
Progression-free Survival (PFS) Assessed by IRC
Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months)
PFS Assessed by Investigator
Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months)
Overall Survival (OS)
Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months)
Disease Control Rate (DCR) Assessed by IRC
Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months)
DCR Assessed by Investigator
Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months)
Clinical Benefit Rate (CBR) Assessed by IRC
Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months)
CBR Assessed by Investigator
Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months)
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Visual Analogue Score (VAS)
Time frame: Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status
Time frame: Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days)
EORTC QLQ - Hepatocellular Carcinoma 18 Questions (HCC18): Index Scores
Time frame: Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days)
Number of Participants With Adverse Events
Time frame: From first dose up to 30 days after the last dose of study drug; up to approximately 4 years and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36872927Ren Z, Ducreux M, Abou-Alfa GK, Merle P, Fang W, Edeline J, Li Z, Wu L, Assenat E, Hu S, Rimassa L, Zhang T, Blanc JF, Pan H, Ross P, Yen CJ, Tran A, Shao G, Bouattour M, Chen Y, Meyer T, Hou J, Tougeron D, Bai Y, Hou MM, Meng Z, Wu J, Li V, Chica-Duque S, Cheng AL. Tislelizumab in Patients with Previously Treated Advanced Hepatocellular Carcinoma (RATIONALE-208): A Multicenter, Non-Randomized, Open-Label, Phase 2 Trial. Liver Cancer. 2022 Oct 4;12(1):72-84. doi: 10.1159/000527175. eCollection 2023 Feb.
- Background: PubMed 34518988Serrano D, Podger L, Barnes G, Song J, Tang B. Psychometric validation of the EORTC QLQ-HCC18 in patients with previously treated unresectable hepatocellular carcinoma. Qual Life Res. 2022 Mar;31(3):937-950. doi: 10.1007/s11136-021-02992-1. Epub 2021 Sep 13.
- Individual participant dataSharing planned: Yes
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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.
Study Director study director
BeiGene
54 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab in people with Hepatocellular Carcinoma (HCC), run by BeiGene at 54 sites in 8 countries.
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 7 inclusion and 12 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 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in China, France, Taiwan, United Kingdom, Spain and 3 more countries. 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?
Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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) Assessed by Independent Review Committee (IRC) (time frame: From date of first dose to primary analysis data cut-off date of 30-June-2021 (up to approximately 3 years and 3 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 NCT03419897, which also lists 2 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 26 Oct 2024.