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A prospective, single-arm, open phase II clinical study of anlotinib combined with oral cyclophosphamide in the treatment of platinum-resistant recurrent epithelial ovarian cancer

Anlotinib combined with oral cyclophosphamide in the treatment of platinum-resistant recurrent epithelial ovarian cancer

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100043955
Enrollment
Unknown
Registered
2021-03-06
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-07-12

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

Conditions

Platinum-resistant recurrent epithelial ovarian cancer

Interventions

Single arm:Anlotinib plus cyclophosphamide

Sponsors

Chen Jing
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Epithelial ovarian cancer confirmed by histological diagnosis; 2. Patients with secondary platinum resistance recurrence are required to have at least received first-line platinum-containing chemotherapy; the last use of platinum-containing chemotherapy = 3.0 x 10^9, absolute neutrophil count >= 1.5 x 10^9, platelet >= 70 x 10^9, hemoglobin >= 80g/L, ALT and AST are less than the upper limit of normal 2 times, total bilirubin is less than or equal to the upper limit of normal, and serum creatinine is less than the upper limit of normal; 8. Bone marrow suppression occurred during chemotherapy; 9. Sign informed consent.

Exclusion criteria

Exclusion criteria: If the patient does not meet the inclusion criteria or any of the following Exclude from this study: 1. Cases considered by the investigator to be unsuitable for inclusion in this study; 2. Those who are known to be allergic to any of the drugs in the study; 3. Those who have a history of prolonged QT interval; 4. In the 6 months before the enrollment in the study, unstable angina, myocardial infarction, Grade III-IV cardiac insufficiency (NYHA standard); 5. Those with active ulcers, intestinal perforation, or intestinal obstruction; 6. Those who have a history of gastrointestinal perforation within 28 days before being selected for the study; 7. Those with active bleeding or bleeding tendency; 8. 6 An arterial/venous thrombosis event, such as a cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism; 9. Hypertension not controlled by drugs; 10. Those who have undergone major surgery within 28 days; 11. Patients who have had any brain metastases or currently have brain metastases; 12. People with a history of psychotropic drug abuse and unable to quit or have mental disorders; 13. Participated in other anti-tumor drug clinical trials within four weeks.

Design outcomes

Primary

MeasureTime frame
Objective response rate;Progression free survival time;Duration of relief;Safety and tolerability;

Countries

China

Contacts

Public ContactHe Shanyang

Guangdong Provincial People's Hospital

hsy5g777@sina.com+86 13068805953

Outcome results

None listed

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