Actively Recruiting
Clinical Study of Individualized Treatment of Relapsed or Drug-resistant Advanced Gynecological Tumors Guided by PTC Model
Led by Hua Li · Updated on 2024-01-30
40
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The clinical treatment of patients with resistant/relapsed/advanced gynecological malignancies is very difficult, and the difficulty lies in the selection of effective drugs. This study was a cohort study of recurrent/drug-resistant advanced ovarian high-grade serous carcinoma and advanced/recurrent endometrial adenocarcinoma treated in our hospital. A total of 20 cases were included in the proposed study group, including 12 cases of high-grade serous ovarian carcinoma and 8 cases of endometrial adenocarcinoma. Twenty patients who did not use PTC model to guide treatment at the same period were selected as controls. To compare the consistency of in vitro drug sensitivity detection results of PTC microtumor with clinical therapeutic effect, and to explore the feasibility of using PTC microtumor model to guide the treatment of patients with drug-resistant/recurrent advanced ovarian epithelial cancer or endometrial cancer. The clinical therapeutic effects of the study group and the control group were compared, and the rates of CR, PR, SD, PFS, OS and TTP were evaluated by RECIST1.1 standard. PTC models based on different clinical samples (tissue and ascites) were compared to analyze the consistency of in vitro drug sensitivity detection results and the relationship with clinical efficacy.
CONDITIONS
Official Title
Clinical Study of Individualized Treatment of Relapsed or Drug-resistant Advanced Gynecological Tumors Guided by PTC Model
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Diagnosed with recurrent or drug-resistant advanced high-grade ovarian serous cancer or advanced/recurrent endometrial adenocarcinoma
- Life expectancy greater than 6 months
- Malignant tumors not currently treated by other systems or in an active phase
- At least one measurable target lesion according to RECIST1.1 criteria
- Available fresh tissue or abdominal effusion samples sufficient for cell culture
- Physical strength score ECOG 0-2
- Major organ functions meeting clinical treatment requirements including blood counts, liver and kidney function, heart function, and ECG criteria
- Consent to abstain from sex or use effective contraception during treatment and for 7 months after last dose if not menopausal or surgically sterilized
- Willingness to provide informed consent and comply with follow-up
You will not qualify if you...
- Unable to provide sufficient fresh tissue or fluid samples
- Pregnant or lactating women, or women of childbearing potential unwilling to use effective contraception during the study
- Uncontrolled serious co-morbidities such as heart failure, unstable angina, recent heart attack, severe hypertension, liver or kidney failure, uncontrolled diabetes, arrhythmia, or mental illness
- Any other condition that the investigator judges makes participation unsuitable
AI-Screening
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Trial Site Locations
Total: 1 location
1
Bei Jing Chao-Yang Hospital
Beijing, Beijing Municipality, China, 100025
Actively Recruiting
Research Team
G
Guangming Cao, Ph.D
CONTACT
H
Hua Li, Ph.D
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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