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

NCT ID: NCT06232213

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 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.

Conditions

Personalized Cancer Treatment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

experimental group

The results of PTC microtumor model were used to guide treatment, including 12 cases of ovarian cancer and 8 cases of endometrial cancer.

No interventions assigned to this group

control group

Patients who did not use the PTC model to guide treatment during the same period included 12 cases of ovarian cancer and 8 cases of endometrial cancer.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hua Li

OTHER

Sponsor Role: lead

Responsible Party

Hua Li

Department of Obstetrics and Gynecology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Bei Jing Chao-Yang Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Guangming Cao, Ph.D

Role: CONTACT

caoguangming_2009@126.com

+86 13240104755

Hua Li, Ph.D

Role: CONTACT

+86 01085231831

Facility Contacts

Hua Li, Ph.D

Role: primary

+86 010 85231831

Other Identifiers

LH2401

Identifier Type: -

Identifier Source: org_study_id