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

January 22, 2024 updated by: Hua Li

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hua Li, Ph.D
  • Phone Number: +86 01085231831

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100025
        • Recruiting
        • Bei Jing Chao-Yang Hospital
        • Contact:
          • Hua Li, Ph.D
          • Phone Number: +86 010 85231831

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumor remission status
Time Frame: 24 months
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).
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hua Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • LH2401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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