Clinical trial
The Utility of Circulating Tumor DNA in Monitoring the Response to Pegylated Liposomal Doxorubicin in Platinum-resistant Ovarian Cancer
Name
2210263-1
Description
This observational study is conducted to assess the utility of circulating tumor DNA in monitoring the response to pegylated liposomal doxorubicin in platinum-resistant ovarian cancer，and evaluate the consistency of circulating tumor DNA with imaging and CA125 in platinum-resistant ovarian cancer.
Trial arms
Trial start
2023-08-01
Estimated PCD
2024-04-01
Trial end
2024-10-01
Status
Not yet recruiting
Treatment
pegylated liposomal doxorubicin
All eligible subjects will receive the standard chemotherapy of pegylated liposomal doxorubicin monotherapy.
Arms:
treatment group
Other names:
PLD
Size
20
Primary endpoint
the consistency of circulating tumor DNA with CT scan
at the beginning of Cycle 1 and 3 weeks after Cycle 1. If necessary, also including 3 weeks after Cycle 2（each cycle is 28 days）
Eligibility criteria
Inclusion Criteria:
1. Female, over 18 years of age;
2. Patients with histopathological diagnosis of high-grade serous epithelial ovarian cancer;
3. pathological report:phenotype of p53 mutation；or previous genetic tests of tumor tissue indicated TP53 gene mutations;
4. ECOG≤ 2;
5. Expected survival time ≥3 months;
6. The subjects were able to understand the study process and voluntarily joined the study.
Exclusion Criteria:
1. Pregnant and lactating patients;
2. Patients with severe or uncontrolled infections;
3. Patients who are allergic or intolerant to the investigational drug;
4. Patients who are enrolled in or within a month of another clinical trial.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'peripheral blood'}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2023-08-04
1 organization
1 drug
1 indication
Organization
Fudan UniversityIndication
Ovarian Cancer