Objective Response RateNCT03892577
Real-world Study for Patients With Advanced Hepatobiliary Tumors
An observational study of Objective Response Rate and Progression-free Survival, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The investigators design a large sample size study in the real-world to explore whether targeted therapy and immunotherapy can improve the survival, quality of life and drug safety of patients with advanced hepatobiliary tumors, and analyze the correlation between genetic variation and the effectiveness of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Objective Response Rate, Progression-free Survival, Overall Survival
- What is being tested?
- Precision oncology including targeted therapy and immunotherapy
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 31 Dec 2025
- How long will I take part?
- 4 Weeks
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients With Advanced Hepatobilary Tumors.
Who may be able to join
- Subjects must meet all of the following criteria：
- ≥18 years old, gender is not limited, and life expectancy is at least 6 months.
- Diagnosed as primary liver cancer or biliary malignant tumor by histopathology or confirmed by imaging as HCC (by the American Association for the Study of Liver Diseases or standard for the diagnosis and treatment of primary liver cancer 2017 in China).
- The Barcelona staging classification: class B-C.
- Child-Pugh classification: class A-B.
- At least one measurable lesion (RECIST v1.1)
Show all 12Show fewer
- Unable to perform radical surgery or patient refuse surgery.
- Subjects need palliative treatment, and have received or are undergoing any of the following three treatments:
- Monotherapy or combination therapy with targeted drug associated with genetic variation in the subject.
- Or, treat with pan-target anti-vascular drugs, such as sorafenib, regorafenib, lenvatinib, apatinib.
- Or, immunotherapy or immunotherapy combined with targeted therapy or (and) classical chemotherapy.
- Subjects volunteer to participate in the study and sign informed consent.
Who cannot join
- Patients with one or more of the following criteria should be excluded:
- Patients with early hepatobiliary tumor.
- The Barcelona staging classification: class A.
- Child-Pugh classification: class C.
- Radical surgical resection.
- CT or MRI shows unclear tumor boundary or no measurable lesions (RECIST v1.1).
Show all 10Show fewer
- Drug abuse, or any medical, psychological, or social condition that may affect the study, patient compliance, or even compromise the safety of the patient.
- Conduct other experimental drug treatments other than this test within 4 weeks before the start of the study; or participate in another clinical study that has an impact on the results of this study.
- Mental or medical instability makes patients unable or unwilling to sign informed consent.
- Patients after comprehensive assessment are considered by the investigators to be unsuitable for participating in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Xiaobo Yang, 010-69156043 ext. 010-69156043, zhaoht@pumch.cn
About this study
Official title: Real-world Study for Targeted Therapy and Immunotherapy in Patients With Advanced Hepatobiliary Tumors: a Multi-centers, Open-assess Observational Study.
The investigators design a large sample size study in the real-world to explore whether targeted therapy and immunotherapy can improve the survival, quality of life and drug safety of patients with advanced hepatobiliary tumors, and analyze the correlation between genetic variation and the effectiveness of therapy.
Read the detailed description
This trial is a multicenter, non-random, open and observational real-world study. It is estimated that 2000 patients with advanced hepatobiliary tumors will be enrolled in about 20 research centers. And it is planned to complete the enrollment within 2 years and it is expected that all enrolled subjects will reach the observation end point in 5 years.
After primary screening of all the patients, the investigators will further collect next-generation sequence(NGS) data and immunohistochemical data from the subjects, and enroll patients with any type of the following three treatment program: 1. Monotherapy or combination therapy with the targeted drug related to genetic variation of the subject; 2. Treatment with pan-target anti-angiogenic drugs, such as sorafenib, regorafenib, lenvatinib, apatinib, etc; 3. Immunotherapy or immunotherapy combined with targeted therapy.
The investigators will collect subjects' data from assessment centers each month and the efficacy, quality of life, and safety of treatment will be evaluated.
This trial plans to conduct an interim analysis and final analysis after collecting 500 cases, 1000 cases, and 2000 subjects, 3000 subjects,and explore the clinical application value of targeted therapy and immunotherapy in advanced hepatobiliary tumors in real world.
- Conditions
- Objective Response Rate, Progression-free Survival, Overall Survival, Disease Control Rate, Duration of Response, Five-year Survival Rate
- Being tested
- Precision oncology including targeted therapy and immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision oncology including targeted therapy and immunotherapyDrug
Therapeutic regimens are based on the clinicopathological features, genomic alterations, advices from multidisciplinary tumor board and willings from patients.
| Study group | Role | What they receive |
|---|---|---|
| Patients with advanced hepatobiliary tumors | 2000 patients with advanced hepatobiliary tumors will be enrolled and the enroll patients should be treat with any type of the following three treatment program:
1. Monotherapy or combination therapy with the targeted drug related to genetic variation of the subject;
2. Treatment with pan-target anti-angiogenic drugs, such as sorafenib, regorafenib, lenvatinib, apatinib, etc;
3. Immunotherapy or immunotherapy combined with targeted therapy or (and) chemotherapy. Receives: Drug: Precision oncology including targeted therapy and immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Time from the date of initial treatment to death for any cause.
Measured: two years
Progression-free Survival (PFS)
A duration from the date of initial treatment with apatinib to disease progression (as defined by RECIST) or death.
Measured: six months
Secondary outcomes (4)
Objective Response Rate (ORR)
Percentage of subjects with complete response and partial response.
Measured: one year
Disease Control Rate (DCR)
Percentage of subjects with complete remission, partial remission, or stable disease during treatment or within 30 days of termination of test drug.
Measured: six months
Incidence of Treatment-Emergent Adverse Event
Percentage of subjects who develop any adverse events (CTCAE 4.0).
Measured: one year
Quality of Life (QoL) after treatment
The life quality of every subject will be assessed every 3 months according to the 45-item FACT-Hep questionnaire, which assesses generic HRQL concerns and disease-specific issues.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Jul 2017
- Primary completion1 Oct 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Objective Response RateStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- OrigiMed
- Responsible party
- Sponsor
- Investigators
- Haitao Zhao, Study chair, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892577
- Sponsor's protocol ID
- JS-1391
- Status last verified
- Mar 2023
- First submitted
- 25 Dec 2018
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
PubMed 26808342Moriguchi M, Umemura A, Itoh Y. Current status and future prospects of chemotherapy for advanced hepatocellular carcinoma. Clin J Gastroenterol. 2016 Aug;9(4):184-90. doi: 10.1007/s12328-016-0670-7. Epub 2016 Jul 11.
PubMed 27401471Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.
PubMed 18650514Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. doi: 10.1016/S1470-2045(08)70285-7. Epub 2008 Dec 16.
PubMed 19095497Sharma A, Dwary AD, Mohanti BK, Deo SV, Pal S, Sreenivas V, Raina V, Shukla NK, Thulkar S, Garg P, Chaudhary SP. Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol. 2010 Oct 20;28(30):4581-6. doi: 10.1200/JCO.2010.29.3605. Epub 2010 Sep 20.
PubMed 20855823Rodriguez R, Miller KM. Unravelling the genomic targets of small molecules using high-throughput sequencing. Nat Rev Genet. 2014 Dec;15(12):783-96. doi: 10.1038/nrg3796. Epub 2014 Oct 14.
PubMed 25311424Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.
PubMed 20375404Hofstatter E, Mehra K, Yushak M, Pusztai L. Tumor profiling and the incidentalome: patient decisions and risks. Future Oncol. 2015;11(24):3299-305. doi: 10.2217/fon.15.260. Epub 2015 Nov 12.
PubMed 26562094Endrullat C, Glokler J, Franke P, Frohme M. Standardization and quality management in next-generation sequencing. Appl Transl Genom. 2016 Jul 1;10:2-9. doi: 10.1016/j.atg.2016.06.001. eCollection 2016 Sep.
PubMed 27668169Gadgeel SM. Personalized Therapy of Non-small Cell Lung Cancer (NSCLC). Adv Exp Med Biol. 2016;890:203-22. doi: 10.1007/978-3-319-24932-2_11.
PubMed 26703806Millner LM, Strotman LN. The Future of Precision Medicine in Oncology. Clin Lab Med. 2016 Sep;36(3):557-73. doi: 10.1016/j.cll.2016.05.003.
PubMed 27514468Drilon A, Wang L, Arcila ME, Balasubramanian S, Greenbowe JR, Ross JS, Stephens P, Lipson D, Miller VA, Kris MG, Ladanyi M, Rizvi NA. Broad, Hybrid Capture-Based Next-Generation Sequencing Identifies Actionable Genomic Alterations in Lung Adenocarcinomas Otherwise Negative for Such Alterations by Other Genomic Testing Approaches. Clin Cancer Res. 2015 Aug 15;21(16):3631-9. doi: 10.1158/1078-0432.CCR-14-2683. Epub 2015 Jan 7.
PubMed 25567908Li S, Mao M. Next generation sequencing reveals genetic landscape of hepatocellular carcinomas. Cancer Lett. 2013 Nov 1;340(2):247-53. doi: 10.1016/j.canlet.2012.09.027. Epub 2012 Oct 12.
PubMed 23063663Schulze K, Nault JC, Villanueva A. Genetic profiling of hepatocellular carcinoma using next-generation sequencing. J Hepatol. 2016 Nov;65(5):1031-1042. doi: 10.1016/j.jhep.2016.05.035. Epub 2016 Jun 2.
PubMed 27262756Wang YY, Yang X, Wang YC, Long JY, Sun HS, Li YR, Xun ZY, Zhang N, Xue JN, Ning C, Zhang JW, Zhu CP, Zhang LH, Yang XB, Zhao HT. Clinical outcomes of lenvatinib plus transarterial chemoembolization with or without programmed death receptor-1 inhibitors in unresectable hepatocellular carcinoma. World J Gastroenterol. 2023 Mar 14;29(10):1614-1626. doi: 10.3748/wjg.v29.i10.1614.
PubMed 36970591
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Study for Targeted Therapy and Immunotherapy in Patients With Advanced Hepatobiliary Tumors: a Multi-centers, Open-assess Observational Study.
- ClinicalTrials.gov ID
- NCT03892577
- Acronym / sponsor ID
- JS-1391
- Conditions
- Objective Response Rate, Progression-free Survival, Overall Survival, Disease Control Rate, Duration of Response, Five-year Survival Rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- OrigiMed
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Mar 2019 (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.
The investigators design a large sample size study in the real-world to explore whether targeted therapy and immunotherapy can improve the survival, quality of life and drug safety of patients with advanced hepatobiliary tumors, and analyze the correlation between genetic variation and the effectiveness of therapy.
Detailed description
This trial is a multicenter, non-random, open and observational real-world study. It is estimated that 2000 patients with advanced hepatobiliary tumors will be enrolled in about 20 research centers. And it is planned to complete the enrollment within 2 years and it is expected that all enrolled subjects will reach the observation end point in 5 years.
After primary screening of all the patients, the investigators will further collect next-generation sequence(NGS) data and immunohistochemical data from the subjects, and enroll patients with any type of the following three treatment program: 1. Monotherapy or combination therapy with the targeted drug related to genetic variation of the subject; 2. Treatment with pan-target anti-angiogenic drugs, such as sorafenib, regorafenib, lenvatinib, apatinib, etc; 3. Immunotherapy or immunotherapy combined with targeted therapy.
The investigators will collect subjects' data from assessment centers each month and the efficacy, quality of life, and safety of treatment will be evaluated.
This trial plans to conduct an interim analysis and final analysis after collecting 500 cases, 1000 cases, and 2000 subjects, 3000 subjects,and explore the clinical application value of targeted therapy and immunotherapy in advanced hepatobiliary tumors in real world.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with advanced hepatobiliary tumors | – | Drug: Precision oncology including targeted therapy and immunotherapy2000 patients with advanced hepatobiliary tumors will be enrolled and the enroll patients should be treat with any type of the following three treatment program: 1. Monotherapy or combination therapy with the targeted drug related to genetic variation of the subject; 2. Treatment with pan-target anti-angiogenic drugs, such as sorafenib, regorafenib, lenvatinib, apatinib, etc; 3. Immunotherapy or immunotherapy combined with targeted therapy or (and) chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients With Advanced Hepatobilary Tumors.
Key inclusion criteria (12 listed)
- Subjects must meet all of the following criteria：
- ≥18 years old, gender is not limited, and life expectancy is at least 6 months.
- Diagnosed as primary liver cancer or biliary malignant tumor by histopathology or confirmed by imaging as HCC (by the American Association for the Study of Liver Diseases or standard for the diagnosis and treatment of primary liver cancer 2017 in China).
- The Barcelona staging classification: class B-C.
- Child-Pugh classification: class A-B.
Key exclusion criteria (10 listed)
- Patients with early hepatobiliary tumor.
- The Barcelona staging classification: class A.
- Child-Pugh classification: class C.
- Radical surgical resection.
- CT or MRI shows unclear tumor boundary or no measurable lesions (RECIST v1.1).
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 |
|---|---|---|
| Precision oncology including targeted therapy and immunotherapyTherapeutic regimens are based on the clinicopathological features, genomic alterations, advices from multidisciplinary tumor board and willings from patients. | Drug | Patients with advanced hepatobiliary tumors |
Primary outcome
Overall Survival (OS)
Time frame: two years
Time from the date of initial treatment to death for any cause.
Progression-free Survival (PFS)
Time frame: six months
A duration from the date of initial treatment with apatinib to disease progression (as defined by RECIST) or death.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: one year
Disease Control Rate (DCR)
Time frame: six months
Incidence of Treatment-Emergent Adverse Event
Time frame: one year
Quality of Life (QoL) after treatment
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Background: PubMed 26808342Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
- Background: PubMed 27401471Moriguchi M, Umemura A, Itoh Y. Current status and future prospects of chemotherapy for advanced hepatocellular carcinoma. Clin J Gastroenterol. 2016 Aug;9(4):184-90. doi: 10.1007/s12328-016-0670-7. Epub 2016 Jul 11.
- Background: PubMed 18650514Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.
- Background: PubMed 19095497Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. doi: 10.1016/S1470-2045(08)70285-7. Epub 2008 Dec 16.
- Background: PubMed 20855823Sharma A, Dwary AD, Mohanti BK, Deo SV, Pal S, Sreenivas V, Raina V, Shukla NK, Thulkar S, Garg P, Chaudhary SP. Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol. 2010 Oct 20;28(30):4581-6. doi: 10.1200/JCO.2010.29.3605. Epub 2010 Sep 20.
- Background: PubMed 25311424Rodriguez R, Miller KM. Unravelling the genomic targets of small molecules using high-throughput sequencing. Nat Rev Genet. 2014 Dec;15(12):783-96. doi: 10.1038/nrg3796. Epub 2014 Oct 14.
- Background: PubMed 20375404Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.
- Background: PubMed 26562094Hofstatter E, Mehra K, Yushak M, Pusztai L. Tumor profiling and the incidentalome: patient decisions and risks. Future Oncol. 2015;11(24):3299-305. doi: 10.2217/fon.15.260. Epub 2015 Nov 12.
- Background: PubMed 27668169Endrullat C, Glokler J, Franke P, Frohme M. Standardization and quality management in next-generation sequencing. Appl Transl Genom. 2016 Jul 1;10:2-9. doi: 10.1016/j.atg.2016.06.001. eCollection 2016 Sep.
- Background: PubMed 26703806Gadgeel SM. Personalized Therapy of Non-small Cell Lung Cancer (NSCLC). Adv Exp Med Biol. 2016;890:203-22. doi: 10.1007/978-3-319-24932-2_11.
- Background: PubMed 27514468Millner LM, Strotman LN. The Future of Precision Medicine in Oncology. Clin Lab Med. 2016 Sep;36(3):557-73. doi: 10.1016/j.cll.2016.05.003.
- Background: PubMed 25567908Drilon A, Wang L, Arcila ME, Balasubramanian S, Greenbowe JR, Ross JS, Stephens P, Lipson D, Miller VA, Kris MG, Ladanyi M, Rizvi NA. Broad, Hybrid Capture-Based Next-Generation Sequencing Identifies Actionable Genomic Alterations in Lung Adenocarcinomas Otherwise Negative for Such Alterations by Other Genomic Testing Approaches. Clin Cancer Res. 2015 Aug 15;21(16):3631-9. doi: 10.1158/1078-0432.CCR-14-2683. Epub 2015 Jan 7.
- Individual participant dataSharing planned: Undecided
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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.
Haitao Zhao study chair
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Objective Response Rate and Progression-free Survival, 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 10 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: status not confirmed, as of the sponsor's last update on 29 Mar 2023. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaobo Yang (010-69156043 ext. 010-69156043, zhaoht@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: two years). 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 NCT03892577, which also lists 29 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 29 Mar 2023.