Organoid-guided Personalized Treatment of Pleural Effusion

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT06959173
• Lead Sponsor: Henan Cancer Hospital

Brief 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.

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:

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.

Study Timeline

• Status Verified: 2024-12
• Study Start: 2025-02-21
• Study First Submitted: 2025-04-28
• Study First Submitted QC: 2025-04-28
• Last Update Submitted: 2025-04-28
• Study First Posted: 2025-05-06
• Last Update Posted: 2025-05-06
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	up to 12 months	Evaluation of therapeutic efficacy for pleural effusion: Objective Response Rate (ORR)

Secondary Outcome Measures

Name	Time	Method
Evaluation of efficacy in primary pulmonary lesions: Objective response rate (ORR)	up to 24 months	Assessed by Investigator According to RECIST v1.1

Trial Locations

Locations (1)

Henan cancer hospital; 🇨🇳 Zhengzhou, Henan, China