Breast Cancer, Colorectal Cancer, Gastric Cancer, Lung Cancer
Conditions
Keywords
PTC: Patient-derived tumor-like cell clusters
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.
Interventions
DIAGNOSTIC_TESTPatient-derived tumor-like cell clusters (PTC) drug sensitivity testing.
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.
Sponsors
Beijing GeneX MedLab Co., Ltd
Liu Huang
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response (CR) | 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. |
| Partial Response (PR) | 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. |
| Progressive Disease (PD) | 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. |
| Stable Disease (SD) | 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. |
Countries
China
Contacts
Primary ContactLiu Huang
Outcome results
None listed