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

Liu Huang

Status: Enrolling

Conditions: Breast Cancer; Gastric Cancer; Lung Cancer; Colorectal Cancer

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06413212

TJ-IRB20230704

Details and patient eligibility

About

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

Full description

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

55 participants in 1 patient group

Case group

Description:

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

Treatment:

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