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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLiu Huang

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnant or lactating women.

Have Participated other clinical trials in six months.

Severe liver dysfunction.

Severe renal dysfunction.

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

55 Participants
are divided into 1 treatment group
Group A: Case group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
up to 12 months
2

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.

Time frame
up to 12 months
3

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.

Time frame
up to 12 months
4

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.

Time frame
up to 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Liu Huang

Lead sponsor

Tongji Hospital

Sponsor institution

Beijing GeneX MedLab Co., Ltd

Collaborator