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A clinical study of a novel personalized drug sensitivity screening system in platinum-resistant ovarian cancer patients

A clinical study of a novel personalized drug sensitivity screening system in platinum-resistant ovarian cancer patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800016766
Enrollment
Unknown
Registered
2018-06-22
Start date
2018-06-12
Completion date
Unknown
Last updated
2018-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ovarian cancer

Interventions

experimental group:Patient medication plan based on Mini PDX drug sensitivity test

Sponsors

Obstetrics & Gynecology Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Female over 18 years of age, ability and willingness to give written informed consent; 2) ECOG Scale of Performance Status 0-2; 3) life expectancy of at least 3 months; 4) Recurrence of platinum resistance (recurrence of tumor within 6 months after platinum-based chemotherapy) and ovarian cancer with measurable lesions (meet RECIST criteria); 5) Patients with multi-line chemotherapy drugs resistance, second-line and above chemotherapy failures or persistent ovarian cancer; 6) Histologically-confirmed epithelial ovarian(as assessed by RECIST criteria), and the lesions are sufficiently big so that the obtaining of the specimens won't affect the pathologic diagnosis; 7) From the last chemotherapy time = 4 weeks; 8) The damage from other treatments had been recovered; 9) To receive other cytotoxic drugs, radiation or surgery = 4weeks, and the wound has healed completely; 10) The function of the major organs (liver, kidney, heart) is almost normal.

Exclusion criteria

Exclusion criteria: 1) Tumor tissue is too small or too little ascites to obtain enough tumor cells; 2) Patients with uncontrolled hypertension after taking hypertension drugs (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg); 3)Patients with grade II cardiovascular disease or arrhythmias (including QTc interval male = 450 ms, female =470 ms) or cardiac dysfunction; 4) There are several factors that affect oral medicine,such as inability to swallow, chronic diarrhea, and intestinal obstruction; 5) Cagulation abnormalities(INR>1.5×ULNAPTT>1.5×ULN). Patients with bleeding tendency, receiving thrombolytics or anticoagulants;; 6) Positive urinary protein(uric albumen check(++),or Twenty-four hours urinary protein content>1.0g); 7) The central nervous system with symptoms and activity is transferred; 8) Pregnant or lactating women; 9) Patients requesting concealment; 10) Patients considered inappropriate by researchers.

Design outcomes

Primary

MeasureTime frame
progression free survival, PFS;

Secondary

MeasureTime frame
Overall survival, OS;Objective response rate, ORR;disease control rate, DCR;progressive disease, PD;

Countries

China

Contacts

Public ContactKang Yu

Obstetrics & Gynecology Hospital of Fudan University

yukang@fudan.edu.cn+86 13636328211

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026