Exploratory Study of Precise Therapy for Advanced Tumor Patients With Malignant Hydrothorax or Ascites by Using PTC Drug Sensitivity Testing

NCT ID: NCT06413212

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-04

Study Completion Date

2025-12-31

Brief Summary

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To explore the consistency between result of PTC drug screening tests and actual clinical outcome for patients with advanced malignancy.

Detailed Description

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This study is anticipated to enroll 55 patients with advanced malignancy, and fresh malignant effusion samples collected from patients would be detected by PTC drug screening. In addition, patients would receive 2 cycles of personal therapy based on results of screening tests. By combining PTC drug sensitivity results with patient's treatment process and clinical feedback, researchers may evaluate the sensitiveness and specificity of PTC drug screening technique in predicting clinical outcome for advanced malignancy patients.

Conditions

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Lung Cancer Breast Cancer Gastric Cancer Colorectal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Case group

Participants who were diagnosed as advanced malignancy and would receive 2 cycles of personal therapy based on PTC drug screening tests.

Patient-derived tumor-like cell clusters (PTC) drug sensitivity testing.

Intervention Type DIAGNOSTIC_TEST

Fresh malignant effusion samples were collected from advanced malignancy patients for PTC drug sensitivity testing, then assess the accuracy of this diagnostic test by combination and analysis with final clinical outcome.

Interventions

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Patient-derived tumor-like cell clusters (PTC) drug sensitivity testing.

Fresh malignant effusion samples were collected from advanced malignancy patients for PTC drug sensitivity testing, then assess the accuracy of this diagnostic test by combination and analysis with final clinical outcome.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. 18 to 75 years old, regardless of gender.
2. Score of nutrition risk screening 2002 (NRS2002) is less than 3, NRS20023.
3. Advanced and unresectable malignancy confirmed by biopsy diagnosis.
4. Able to tolerate anti-tumor treatment, and without serious cardiopulmonary and other underlying diseases.
5. Score of eastern cooperative oncology group (ECOG) is not higher than 2, ECOG≤2.
6. Anticipated survival exceed six months.
7. At least one measurable lesions (according to RECIST 1.1)
8. Resistance or intolerance to standard therapy regimens.
9. Signed informed consent form voluntarily.

Exclusion Criteria

1. Pregnant or lactating women.
2. Have Participated other clinical trials in six months.
3. Severe liver dysfunction.
4. Severe renal dysfunction.
5. Patients with cognitive disorder, mental diseases and terrible compliance.
6. Allergic to known chemotherapeutic agents.
7. Other circumstance not suitable to participate in this trial determined by investigators.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing GeneX MedLab Co., Ltd

INDUSTRY

Sponsor Role collaborator

Liu Huang

OTHER

Sponsor Role lead

Responsible Party

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Liu Huang

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Liu Huang

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liu Huang

Role: CONTACT

Facility Contacts

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Liu Huang

Role: primary

References

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Other Identifiers

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TJ-IRB20230704

Identifier Type: -

Identifier Source: org_study_id

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