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

NCT06413212 | Recruiting

• 1 other identifier: TJ-IRB20230704
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer; Breast Cancer; Gastric Cancer; Colorectal Cancer

Keywords

PTC: Patient-derived tumor-like cell clusters

Outcome Measures

Primary Outcomes (4)

• Complete Response (CR)

  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.

  up to 12 months

• Partial Response (PR)

  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.

  up to 12 months

• Progressive Disease (PD)

  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.

  up to 12 months

• Stable Disease (SD)

  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.

  up to 12 months

Study Arms (1)

Case group

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

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

Interventions

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.

Case group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients with malignant effusion, above 18 years of age, at Tongji Hospital, Tongji Medical College of HUST

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liu Huang: lead
• Beijing GeneX MedLab Co., Ltd: collaborator

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (14)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Malignant effusion

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms; Stomach Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Liu Huang

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Huang

CONTACT

63639656; huangliu@tjh.tjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: May 14, 2024
• Study Start: August 4, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

CN (1)