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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-80
SponsorHua Li

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years, ≤80 years

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.

Life expectancy > 6 months;

Malignant tumors that are not being treated by other systems or are in an active phase;

Disqualifiers

Patients who are unable to provide sufficient fresh samples;

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;

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;

Other circumstances in which the investigator determines that participation in the study is not appropriate.

Trial population

Recurrent/drug-resistant and advanced ovarian high-grade serous carcinoma and advanced/recurrent endometrial adenocarcinoma were treated at Beijing Chaoyang Hospital.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 2 trial groups
Group A: experimental group
Group B: control group

Trial outcomes

Primary outcomes

1

tumor remission status

According to RECIST v1.1 criteria, patients were evaluated for tumor remission status (complete response (CR), partial response (PR), stable disease (PR), etc.). SD) or progressive disease (PD).

Time frame
24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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Hua Li

Lead sponsor

Beijing Chao Yang Hospital

Sponsor institution