Organoid-guided Personalized Treatment of Pleural Effusion

Обзор

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.

Подробное описание

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:

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.

Study termination criteria: Reasons for subject withdrawal from the study may include:

1. 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; 2. Subjects were lost to follow-up; 3. die; 4. Other reasons.

Visit the plan: Treatment follow-up for 2 years:

1. Follow-up visits are made every 8 weeks and ± 7 days within 1 year after enrollment (within 48 weeks); 2. 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.

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: up to 12 months]

Вторичные конечные точки (1)

• Evaluation of efficacy in primary pulmonary lesions: Objective response rate (ORR) [Срок оценки: up to 24 months]

Критерии участия

Критерии включения

(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;

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Китай · 1 центр

• Henan cancer hospital — Чжэнчжоу

Публикации

• 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. PMID 25706291
• Penz 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
• Asciak 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
• Clive 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
• Terra 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
• Hackner 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
• Gayen 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
• Bray 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. PMID 38572751

Идентификаторы

NCT: NCT06959173 · 2024-592

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗