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NCT Number: NCT06413212

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

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

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Key information

Conditions

Lung Cancer Breast Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji Hospital

Wuhan, Hubei, 430030, China

Location status: Recruiting

Location contact

Liu Huang

CONTACT

[email protected]

63639656

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnant or lactating women.
  • Have Participated other clinical trials in six months.
  • Severe liver dysfunction.
  • Severe renal dysfunction.
  • Patients with cognitive disorder, mental diseases and terrible compliance.
  • Allergic to known chemotherapeutic agents.
  • Other circumstance not suitable to participate in this trial determined by investigators.

Treatment and study plan

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

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.

Primary outcomes

  1. Complete Response (CR)

    Time frame: up to 12 months

    Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Length is measured in millimeters, refers to RECIST 1.1.

  2. Partial Response (PR)

    Time frame: up to 12 months

    At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Length is measured in millimeters, refers to RECIST.1.1.

  3. Progressive Disease (PD)

    Time frame: up to 12 months

    At least a 20% increase in the sum of diameters of taraet lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression). Length is measured in millimeters, refers to RECIST 1.1.

  4. Stable Disease (SD)

    Time frame: up to 12 months

    Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Length is measured in millimeters, refers to RECIST 1.1.

Study contacts

Contact information is provided by the study sponsor or research team.

Liu Huang

CONTACT

[email protected]

63639656

Sponsors and collaborators

Lead sponsor

Liu Huang

Other

Collaborators

  • Beijing GeneX MedLab Co., Ltd

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 14, 2024
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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