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Recruiting NCT06232213

Clinical Study of Individualized Treatment of Relapsed or Drug-resistant Advanced Gynecological Tumors Guided by PTC Model

Trial Parameters

Condition Personalized Cancer Treatment
Sponsor Hua Li
Study Type OBSERVATIONAL
Phase N/A
Enrollment 40
Sex FEMALE
Min Age 18 Years
Max Age 80 Years
Start Date 2023-09-01
Completion 2026-09-30

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. Age ≥18 years, ≤80 years 2. Recurrent/drug-resistant gynecological tumors include: ① patients with advanced high-grade ovarian serous cancer whose tumor is uncontrolled or recurrent within 6 months after receiving platinum-based chemotherapy; ② Advanced ovarian high-grade serous cancer patients with platinum resistance at first treatment; ③ Patients with advanced or recurrent endometrial adenocarcinoma. 3. Life expectancy \> 6 months; 4. Malignant tumors that are not being treated by other systems or are in an active phase; 5. Have at least one measurable target lesion according to RECIST1.1 criteria; 6. Specimen requirements: fresh specimens with sufficient cell culture, including tissue samples and abdominal effusion; 7. Physical strength score: ECOG 0-2; 8. Major organ functions must meet clinical treatment requirements: * Blood routine: neutrophil (ANC) ≥1.5x109/L; Platelet count (PLT) ≥90x109/L; Hemoglobin (Hb) ≥90g/L; ② Blood biochemistry: total bilirubin (

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