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Efficacy and safety of albumin bound paclitaxel combined with pegylated liposome doxorubicin in the treatment of platinum resistant or refractory ovarian cancer: an open, single arm, phase II prospective study

Efficacy and safety of albumin bound paclitaxel combined with pegylated liposome doxorubicin in the treatment of platinum resistant or refractory ovarian cancer: an open, single arm, phase II prospective study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034609
Enrollment
Unknown
Registered
2020-07-12
Start date
2020-07-13
Completion date
Unknown
Last updated
2020-07-13

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:Efficacy and safety of albumin bound paclitaxel combined with pegylated liposome doxorubicin

Sponsors

Shaanxi Provincial Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years old, = 1.5 * 10^9 / L, platelet >= 75 * 10^9 / L, hemoglobin >= 80 g / L; 10. The liver and kidney functions were basically normal: serum creatinine <= 1.5uln; serum bilirubin <= 1.5uln 11. ALT (AST) <= 2.5uln, if there is liver metastasis, ALT (AST) <= 5.0uln; 12. Life expectancy was more than 3 months.

Exclusion criteria

Exclusion criteria: 1. Patients who had previously received albumin binding paclitaxel treatment; 2. Patients with previous abdominal or pelvic radiotherapy at any site; 3. Patients with central nervous system disease or brain metastasis; 4. In the past 5 years, other malignant tumors except ovarian cancer were found, except for cervical carcinoma in situ and skin cancer without melanoma; 5. Grade >= 2 sensory or motor neuropathy occurred in the past; 6. Serious uncontrolled medical diseases, such as severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc., which will affect the subject's ability to accept the study protocol and are not controlled by the researchers; 7. Known to be allergic, highly sensitive or intolerable to the study related drug or its excipients; 8. Within 30 days after the first chemotherapy, he received other experimental drugs or participated in clinical studies for other anti-cancer purposes; 9. Severe infection occurred within 4 weeks before the start of treatment, including but not limited to infection complications, bacteremia or severe pneumonia requiring hospitalization; 10. HIV positive patients; 11. Patients with positive HBsAg and HBV-DNA titer >= 1 * 10 ^3iu / ml in peripheral blood; if HBsAg is positive and HBV-DNA in peripheral blood is less than 1 × 10 ^ 3iu / ml, if the researcher thinks that chronic hepatitis B is stable and does not increase the risk of subjects, the subjects are eligible to be selected; 12. Hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) antibody were positive, and HCV RNA test was positive. 13. The researchers judged the patients who were not suitable for the study.

Design outcomes

Primary

MeasureTime frame
ORR;

Secondary

MeasureTime frame
PFS;DOR;DCR;Safety;

Countries

China

Contacts

Public ContactGuo-qing Wang

Shaanxi Cancer Hospital

wgq5668@163.com138 9282 8647

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026