Individualized treatment for advanced gynecological tumors

The PTC Microtumor Model is Used to Guide the Feasibility Study of Treatment for Patients With Drug-resistant or Relapsed Advanced Ovarian Epithelial Cancer or Endometrial Cancer

This study is testing a personalized treatment approach for patients with advanced gynecological tumors to see if it works better than standard treatment.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Female
• Sponsor: Beijing Chao Yang Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06232213 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients with relapsed or drug-resistant advanced gynecological tumors, specifically high-grade serous ovarian carcinoma and advanced endometrial adenocarcinoma. It aims to evaluate the effectiveness of a personalized treatment approach guided by a PTC microtumor model. The study will compare clinical outcomes of patients treated using this model against a control group receiving standard treatment. A total of 20 patients will be included in the study group, with a similar number in the control group, to assess the consistency of drug sensitivity results with clinical therapeutic effects.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-80 with recurrent or drug-resistant advanced gynecological tumors.

Not a fit: Patients with gynecological tumors that are currently being treated by other systems or are not in an active phase may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective personalized treatment options for patients with difficult-to-treat gynecological cancers.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in personalized cancer treatment, suggesting potential for success.

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 (TBIL) ≤1.5x upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5xULN; Urea nitrogen (BUN) and creatinine (Cr) ≤1.5 x ULN

(3) Heart color ultrasound: left ventricular ejection fraction (LVEF) ≥55%;

④ 12-lead ECG: Fridericia method corrected QT period (QTcF) \< 470 msec. (9) Consent to abstinence from sex or use of an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment for female patients who are not menopausal or have not been surgically sterilized; (10) Patients participating in the study (or their legal representatives) understand and voluntarily sign informed consent, have good compliance, and are willing to cooperate with follow-up.

Exclusion Criteria:

1. Patients who are unable to provide sufficient fresh samples;
2. pregnant and lactating women, female patients with fertility and positive pregnancy tests, or patients of childbearing age who are unwilling to take effective contraceptive measures during the whole test period;
3. The patient has uncontrollable co-morbidity, including but not limited to: symptomatic congestive heart failure, unstable angina pectoris and myocardial infarction, uncontrolled grade III hypertension, liver insufficiency, renal insufficiency, diabetes uncontrolled blood sugar, arrhythmia and mental illness;
4. Other circumstances in which the investigator determines that participation in the study is not appropriate.

Where this trial is running

Beijing, Beijing Municipality

• Bei Jing Chao-Yang Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Guangming Cao, Ph.D

Conditions: Personalized Cancer Treatment