Clinical trial · Observational
Organoid-guided Personalized Treatment of Pleural Effusion
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- up to 12 months
- description
- Evaluation of therapeutic efficacy for pleural effusion: Objective Response Rate (ORR)
Secondary outcomes (1)
- measure
- Evaluation of efficacy in primary pulmonary lesions: Objective response rate (ORR)
- timeFrame
- up to 24 months
- description
- Assessed by Investigator According to RECIST v1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: 1. A history of malignant tumor in the past 5 years; 2. Complicated with serious complications, such as uncontrolled heart disease, severe arrhythmia requiring medical treatment, persistent watery diarrhea, etc.; 3. Pregnant or lactating female patients; Patients deemed unsuitable for participation in this study.
References
Publications (19)
- BACKGROUNDPorcel 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. PMID 25706291
- BACKGROUNDPenz 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. PMID 28694705
- BACKGROUNDAsciak 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. PMID 29433714
- BACKGROUNDClive 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. PMID 25100651
- BACKGROUNDTerra 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. PMID 29963399
- BACKGROUNDHackner 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. PMID 31205509
- BACKGROUNDGayen 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. PMID 35576996