Clinical trial NCT06413212: Exploratory Study of Precise Therapy for Advanced Tumor Patients With Malignant Hydrothorax or Ascites by Using PTC Drug Sensitivity Testing
Official title: Exploratory Study of Precise Therapy for Advanced Tumor Patients With Malignant Hydrothorax or Ascites by Using PTC Drug Sensitivity Testing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Breast Cancer
Gastric Cancer
Colorectal Cancer
Keywords: PTC: Patient-derived tumor-like cell clusters
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Beijing GeneX MedLab Co., Ltd
First posted: 2024-05-14
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete Response (CR)
timeFrame: up to 12 months
measure: Partial Response (PR)
timeFrame: up to 12 months
measure: Progressive Disease (PD)
timeFrame: up to 12 months
measure: Stable Disease (SD)
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Liu Huang
role: PRINCIPAL_INVESTIGATOR
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