Lung CancerNCT06959173
Organoid-guided Personalized Treatment of Pleural Effusion
An observational study of Lung Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
The study is a single-arm, single-center clinical research that utilizes patient-derived tumor organoids to predict drug sensitivity, thereby assisting clinicians in formulating treatment plans to benefit lung cancer patients with pleural effusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2025to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Lung cancer with malignant pleural effusion
Who may be able to join
- (1)18 years of age and above; (2) Understand and voluntarily sign the informed consent form (ICF), and have good compliance, and can cooperate with diagnosis and follow-up; (3)ECOG score 0-2; (4) Accompanied by malignant pleural effusion; Presence of at least one measurable lesion as assessed by the investigator;
Who cannot join
- A history of malignant tumor in the past 5 years;
- Complicated with serious complications, such as uncontrolled heart disease, severe arrhythmia requiring medical treatment, persistent watery diarrhea, etc.;
- Pregnant or lactating female patients; Patients deemed unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Henan cancer hospital
Zhengzhou, Henan, 475000
Bao xia He, 13283809085, hnszlyygcp@163.com
About this study
The study is a single-arm, single-center clinical research that utilizes patient-derived tumor organoids to predict drug sensitivity, thereby assisting clinicians in formulating treatment plans to benefit lung cancer patients with pleural effusion.
This study is divided into three parts: acquisition of clinical samples from patients, in vitro organoid culture and drug sensitivity testing, and correlation of organoid sensitivity results with clinical medication guidance. Researchers obtained pre-treatment tissue samples and provided them to Suzhou Xianjue Biotechnology Co., Ltd. to establish organoid models. Once established, drug incubation was performed for sensitivity testing. Subsequently, treatment for malignant pleural effusion was guided based on drug sensitivity data.
Read the detailed description
Research name：Organoid-guided personalized treatment of pleural effusion.
Intervention study: Not have.
Research design: The study is a single-arm, single-center clinical research that utilizes patient-derived tumor organoids to predict drug sensitivity, thereby assisting clinicians in formulating treatment plans to benefitlung cancer patients with pleural effusion.
This study is divided into three parts: acquisition of clinical samples from patients, in vitro organoid culture and drug sensitivity testing, and correlation of organoid sensitivity results with clinical medication guidance. Researchers obtained pre-treatment tissue samples and provided them to Suzhou Xianjue Biotechnology Co., Ltd. to establish organoid models. Once established, drug incubation was performed for sensitivity testing. Subsequently, treatment for malignant pleural effusion was guided based on drug sensitivity data.
Sample capacity: 20.
Purpose of research: The purpose of this study is to use the patient-derived organoid model for drug sensitivity testing, to explore the patient-derived organoids for drug sensitivity prediction, so as to achieve the benefit of lung cancer patients with pleural effusion.
Fundamental purpose: Assessment of the efficacy of pleural effusion therapy guided by patient-derived organoid drug sensitivity prediction.
Secondary purpose: Agreement of organoid drug prediction and actual clinical benefit.
Inclusion Criteria:
(1)18 years of age and above; (2) Understand and voluntarily sign the informed consent form (ICF), and have good compliance, and can cooperate with diagnosis and follow-up; (3)ECOG score 0-2; (4) Accompanied by malignant pleural effusion; Presence of at least one measurable lesion as assessed by the investigator;
Exclusion Criteria:
- A history of malignant tumor in the past 5 years;
- Complicated with serious complications, such as uncontrolled heart disease, severe arrhythmia requiring medical treatment, persistent watery diarrhea, etc.;
- Pregnant or lactating female patients; Patients deemed unsuitable for participation in this study.
Study termination criteria: Reasons for subject withdrawal from the study may include:
- The subject withdrew his informed consent. Subjects were free to terminate study participation at any time without being compromised in further treatment. If the subject withdraws informed consent, they will be asked in detail if they agree to participate in safety follow-up, continue efficacy assessment (if not progressing), and survival follow-up;
- Subjects were lost to follow-up;
- die;
- Other reasons.
Visit the plan: Treatment follow-up for 2 years:
- Follow-up visits are made every 8 weeks and ± 7 days within 1 year after enrollment (within 48 weeks);
- Patients will be followed up every 12 weeks ± 7 days within the 1 to 2 years after enrollment (within weeks 49 to 96).
Statistical analysis: Data analysis will be performed using the SPSS statistical software.
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer (NSCLC), Pleural effusion, patient-derived organoids
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Pleural Effusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Evaluation of therapeutic efficacy for pleural effusion: Objective Response Rate (ORR)
Measured: up to 12 months
Secondary outcomes (1)
Evaluation of efficacy in primary pulmonary lesions: Objective response rate (ORR)
Assessed by Investigator According to RECIST v1.1
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start21 Feb 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Qiming Wang, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959173
- Sponsor's protocol ID
- 2024-592
- Status last verified
- Dec 2024
- First submitted
- 28 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Porcel JM, Gasol A, Bielsa S, Civit C, Light RW, Salud A. Clinical features and survival of lung cancer patients with pleural effusions. Respirology. 2015 May;20(4):654-9. doi: 10.1111/resp.12496. Epub 2015 Feb 23.
PubMed 25706291Penz E, Watt KN, Hergott CA, Rahman NM, Psallidas I. Management of malignant pleural effusion: challenges and solutions. Cancer Manag Res. 2017 Jun 23;9:229-241. doi: 10.2147/CMAR.S95663. eCollection 2017.
PubMed 28694705Asciak R, Rahman NM. Malignant Pleural Effusion: From Diagnostics to Therapeutics. Clin Chest Med. 2018 Mar;39(1):181-193. doi: 10.1016/j.ccm.2017.11.004. Epub 2017 Dec 13.
PubMed 29433714Clive AO, Kahan BC, Hooper CE, Bhatnagar R, Morley AJ, Zahan-Evans N, Bintcliffe OJ, Boshuizen RC, Fysh ET, Tobin CL, Medford AR, Harvey JE, van den Heuvel MM, Lee YC, Maskell NA. Predicting survival in malignant pleural effusion: development and validation of the LENT prognostic score. Thorax. 2014 Dec;69(12):1098-104. doi: 10.1136/thoraxjnl-2014-205285. Epub 2014 Aug 6.
PubMed 25100651Terra RM, Dela Vega AJM. Treatment of malignant pleural effusion. J Vis Surg. 2018 May 22;4:110. doi: 10.21037/jovs.2018.05.02. eCollection 2018.
PubMed 29963399Hackner K, Errhalt P, Handzhiev S. Ratio of carcinoembryonic antigen in pleural fluid and serum for the diagnosis of malignant pleural effusion. Ther Adv Med Oncol. 2019 May 22;11:1758835919850341. doi: 10.1177/1758835919850341. eCollection 2019.
PubMed 31205509Gayen S. Malignant Pleural Effusion: Presentation, Diagnosis, and Management. Am J Med. 2022 Oct;135(10):1188-1192. doi: 10.1016/j.amjmed.2022.04.017. Epub 2022 May 14.
PubMed 35576996Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
PubMed 38572751Ferro A, Marinato GM, Mulargiu C, Marino M, Pasello G, Guarneri V, Bonanno L. The study of primary and acquired resistance to first-line osimertinib to improve the outcome of EGFR-mutated advanced Non-small cell lung cancer patients: the challenge is open for new therapeutic strategies. Crit Rev Oncol Hematol. 2024 Apr;196:104295. doi: 10.1016/j.critrevonc.2024.104295. Epub 2024 Feb 20.
PubMed 38382773He J, Huang Z, Han L, Gong Y, Xie C. Mechanisms and management of 3rd-generation EGFR-TKI resistance in advanced non-small cell lung cancer (Review). Int J Oncol. 2021 Nov;59(5):90. doi: 10.3892/ijo.2021.5270. Epub 2021 Sep 24.
PubMed 34558640Passaro A, Mok TSK, Attili I, Wu YL, Tsuboi M, de Marinis F, Peters S. Adjuvant Treatments for Surgically Resected Non-Small Cell Lung Cancer Harboring EGFR Mutations: A Review. JAMA Oncol. 2023 Aug 1;9(8):1124-1131. doi: 10.1001/jamaoncol.2023.0459.
PubMed 37166792Rosell R, Moran T, Queralt C, Porta R, Cardenal F, Camps C, Majem M, Lopez-Vivanco G, Isla D, Provencio M, Insa A, Massuti B, Gonzalez-Larriba JL, Paz-Ares L, Bover I, Garcia-Campelo R, Moreno MA, Catot S, Rolfo C, Reguart N, Palmero R, Sanchez JM, Bastus R, Mayo C, Bertran-Alamillo J, Molina MA, Sanchez JJ, Taron M; Spanish Lung Cancer Group. Screening for epidermal growth factor receptor mutations in lung cancer. N Engl J Med. 2009 Sep 3;361(10):958-67. doi: 10.1056/NEJMoa0904554. Epub 2009 Aug 19.
PubMed 19692684Castellanos E, Feld E, Horn L. Driven by Mutations: The Predictive Value of Mutation Subtype in EGFR-Mutated Non-Small Cell Lung Cancer. J Thorac Oncol. 2017 Apr;12(4):612-623. doi: 10.1016/j.jtho.2016.12.014. Epub 2016 Dec 23.
PubMed 28017789Shi Y, Au JS, Thongprasert S, Srinivasan S, Tsai CM, Khoa MT, Heeroma K, Itoh Y, Cornelio G, Yang PC. A prospective, molecular epidemiology study of EGFR mutations in Asian patients with advanced non-small-cell lung cancer of adenocarcinoma histology (PIONEER). J Thorac Oncol. 2014 Feb;9(2):154-62. doi: 10.1097/JTO.0000000000000033.
PubMed 24419411Zhuang X, Zhao C, Li J, Su C, Chen X, Ren S, Li X, Zhou C. Clinical features and therapeutic options in non-small cell lung cancer patients with concomitant mutations of EGFR, ALK, ROS1, KRAS or BRAF. Cancer Med. 2019 Jun;8(6):2858-2866. doi: 10.1002/cam4.2183. Epub 2019 Apr 24.
PubMed 31016879
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organoid-guided Personalized Treatment of Pleural Effusion
- ClinicalTrials.gov ID
- NCT06959173
- Acronym / sponsor ID
- 2024-592
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer (NSCLC), Pleural effusion, patient-derived organoids
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 6 May 2025 (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 study is a single-arm, single-center clinical research that utilizes patient-derived tumor organoids to predict drug sensitivity, thereby assisting clinicians in formulating treatment plans to benefit lung cancer patients with pleural effusion.
This study is divided into three parts: acquisition of clinical samples from patients, in vitro organoid culture and drug sensitivity testing, and correlation of organoid sensitivity results with clinical medication guidance. Researchers obtained pre-treatment tissue samples and provided them to Suzhou Xianjue Biotechnology Co., Ltd. to establish organoid models. Once established, drug incubation was performed for sensitivity testing. Subsequently, treatment for malignant pleural effusion was guided based on drug sensitivity data.
Detailed description
Research name：Organoid-guided personalized treatment of pleural effusion.
Intervention study: Not have.
Research design: The study is a single-arm, single-center clinical research that utilizes patient-derived tumor organoids to predict drug sensitivity, thereby assisting clinicians in formulating treatment plans to benefitlung cancer patients with pleural effusion.
This study is divided into three parts: acquisition of clinical samples from patients, in vitro organoid culture and drug sensitivity testing, and correlation of organoid sensitivity results with clinical medication guidance. Researchers obtained pre-treatment tissue samples and provided them to Suzhou Xianjue Biotechnology Co., Ltd. to establish organoid models. Once established, drug incubation was performed for sensitivity testing. Subsequently, treatment for malignant pleural effusion was guided based on drug sensitivity data.
Sample capacity: 20.
Purpose of research: The purpose of this study is to use the patient-derived organoid model for drug sensitivity testing, to explore the patient-derived organoids for drug sensitivity prediction, so as to achieve the benefit of lung cancer patients with pleural effusion.
Fundamental purpose: Assessment of the efficacy of pleural effusion therapy guided by patient-derived organoid drug sensitivity prediction.
Secondary purpose: Agreement of organoid drug prediction and actual clinical benefit.
Inclusion Criteria:
(1)18 years of age and above; (2) Understand and voluntarily sign the informed consent form (ICF), and have good compliance, and can cooperate with diagnosis and follow-up; (3)ECOG score 0-2; (4) Accompanied by malignant pleural effusion; Presence of at least one measurable lesion as assessed by the investigator;
Exclusion Criteria:
- A history of malignant tumor in the past 5 years;
- Complicated with serious complications, such as uncontrolled heart disease, severe arrhythmia requiring medical treatment, persistent watery diarrhea, etc.;
- Pregnant or lactating female patients; Patients deemed unsuitable for participation in this study.
Study termination criteria: Reasons for subject withdrawal from the study may include:
- The subject withdrew his informed consent. Subjects were free to terminate study participation at any time without being compromised in further treatment. If the subject withdraws informed consent, they will be asked in detail if they agree to participate in safety follow-up, continue efficacy assessment (if not progressing), and survival follow-up;
- Subjects were lost to follow-up;
- die;
- Other reasons.
Visit the plan: Treatment follow-up for 2 years:
- Follow-up visits are made every 8 weeks and ± 7 days within 1 year after enrollment (within 48 weeks);
- Patients will be followed up every 12 weeks ± 7 days within the 1 to 2 years after enrollment (within weeks 49 to 96).
Statistical analysis: Data analysis will be performed using the SPSS statistical software.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer with malignant pleural effusion
Key inclusion criteria (1 listed)
- (1)18 years of age and above; (2) Understand and voluntarily sign the informed consent form (ICF), and have good compliance, and can cooperate with diagnosis and follow-up; (3)ECOG score 0-2; (4) Accompanied by malignant pleural effusion; Presence of at least one measurable lesion as assessed by the investigator;
Key exclusion criteria (3 listed)
- A history of malignant tumor in the past 5 years;
- Complicated with serious complications, such as uncontrolled heart disease, severe arrhythmia requiring medical treatment, persistent watery diarrhea, etc.;
- Pregnant or lactating female patients; Patients deemed unsuitable for participation in this study.
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
Objective Response Rate (ORR)
Time frame: up to 12 months
Evaluation of therapeutic efficacy for pleural effusion: Objective Response Rate (ORR)
1 secondary outcome
Evaluation of efficacy in primary pulmonary lesions: Objective response rate (ORR)
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Background: PubMed 25706291Porcel JM, Gasol A, Bielsa S, Civit C, Light RW, Salud A. Clinical features and survival of lung cancer patients with pleural effusions. Respirology. 2015 May;20(4):654-9. doi: 10.1111/resp.12496. Epub 2015 Feb 23.
- Background: PubMed 28694705Penz E, Watt KN, Hergott CA, Rahman NM, Psallidas I. Management of malignant pleural effusion: challenges and solutions. Cancer Manag Res. 2017 Jun 23;9:229-241. doi: 10.2147/CMAR.S95663. eCollection 2017.
- Background: PubMed 29433714Asciak R, Rahman NM. Malignant Pleural Effusion: From Diagnostics to Therapeutics. Clin Chest Med. 2018 Mar;39(1):181-193. doi: 10.1016/j.ccm.2017.11.004. Epub 2017 Dec 13.
- Background: PubMed 25100651Clive AO, Kahan BC, Hooper CE, Bhatnagar R, Morley AJ, Zahan-Evans N, Bintcliffe OJ, Boshuizen RC, Fysh ET, Tobin CL, Medford AR, Harvey JE, van den Heuvel MM, Lee YC, Maskell NA. Predicting survival in malignant pleural effusion: development and validation of the LENT prognostic score. Thorax. 2014 Dec;69(12):1098-104. doi: 10.1136/thoraxjnl-2014-205285. Epub 2014 Aug 6.
- Background: PubMed 29963399Terra RM, Dela Vega AJM. Treatment of malignant pleural effusion. J Vis Surg. 2018 May 22;4:110. doi: 10.21037/jovs.2018.05.02. eCollection 2018.
- Background: PubMed 31205509Hackner K, Errhalt P, Handzhiev S. Ratio of carcinoembryonic antigen in pleural fluid and serum for the diagnosis of malignant pleural effusion. Ther Adv Med Oncol. 2019 May 22;11:1758835919850341. doi: 10.1177/1758835919850341. eCollection 2019.
- Background: PubMed 35576996Gayen S. Malignant Pleural Effusion: Presentation, Diagnosis, and Management. Am J Med. 2022 Oct;135(10):1188-1192. doi: 10.1016/j.amjmed.2022.04.017. Epub 2022 May 14.
- Background: PubMed 38572751Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- Background: PubMed 38382773Ferro A, Marinato GM, Mulargiu C, Marino M, Pasello G, Guarneri V, Bonanno L. The study of primary and acquired resistance to first-line osimertinib to improve the outcome of EGFR-mutated advanced Non-small cell lung cancer patients: the challenge is open for new therapeutic strategies. Crit Rev Oncol Hematol. 2024 Apr;196:104295. doi: 10.1016/j.critrevonc.2024.104295. Epub 2024 Feb 20.
- Background: PubMed 34558640He J, Huang Z, Han L, Gong Y, Xie C. Mechanisms and management of 3rd-generation EGFR-TKI resistance in advanced non-small cell lung cancer (Review). Int J Oncol. 2021 Nov;59(5):90. doi: 10.3892/ijo.2021.5270. Epub 2021 Sep 24.
- Background: PubMed 37166792Passaro A, Mok TSK, Attili I, Wu YL, Tsuboi M, de Marinis F, Peters S. Adjuvant Treatments for Surgically Resected Non-Small Cell Lung Cancer Harboring EGFR Mutations: A Review. JAMA Oncol. 2023 Aug 1;9(8):1124-1131. doi: 10.1001/jamaoncol.2023.0459.
- Background: PubMed 19692684Rosell R, Moran T, Queralt C, Porta R, Cardenal F, Camps C, Majem M, Lopez-Vivanco G, Isla D, Provencio M, Insa A, Massuti B, Gonzalez-Larriba JL, Paz-Ares L, Bover I, Garcia-Campelo R, Moreno MA, Catot S, Rolfo C, Reguart N, Palmero R, Sanchez JM, Bastus R, Mayo C, Bertran-Alamillo J, Molina MA, Sanchez JJ, Taron M; Spanish Lung Cancer Group. Screening for epidermal growth factor receptor mutations in lung cancer. N Engl J Med. 2009 Sep 3;361(10):958-67. doi: 10.1056/NEJMoa0904554. Epub 2009 Aug 19.
- Individual participant dataSharing planned: No
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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.
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 Lung Cancer, run by Henan Cancer 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 6 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiming Wang (13783590691, qimingwang1006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: up to 12 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 NCT06959173, which also lists 19 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 6 May 2025.