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A single-arm, single-center, open-label clinical study of apatinib in the treatment of advanced malignant gynecological tumors

A single-arm, single-center, open-label clinical study of apatinib in the treatment of advanced malignant gynecological tumors

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800015267
Enrollment
Unknown
Registered
2018-03-19
Start date
2018-03-19
Completion date
Unknown
Last updated
2018-03-26

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

Conditions

gynecological tumors

Interventions

Case series:apatinib normal treatment

Sponsors

Xinan Hostipal, Chongqing
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patients with a histologic or cytologic diagnosis of advanced breast cancercervical canceruterus cancerovarian cancer, choriocarcinoma; 2. Female, age = 18 years old; 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2; 4. Life expectancy of at least 12 weeks; 5. The main organ function meeting the following: 1) blood routine examination meeting the standards:ANC=1.5×10^9/L; PLT=80×10^9/L; Hb=90g/L(no blood transfusion and blood components support within 14 days, not using G-CSF and other hematopoietic stimulating factor correction); 2) blood biochemical examination meeting the following standards: TBIL<1.5×ULNALTAST<2.5×ULN, hepatic metastasis ALT, AST < 5 x ULN) BUN and Cr=1×ULN, total bilirubin =1.5×ULNendogenous creatinine clearance =50 ml/min (Cockcroft - Gault formula);6.Women of childbearing age must have taken reliable contraceptive measures or have performed a pregnancy test (serum or urine) within 7 days prior to enrollment, and the result is negative, during the test and the last 8 weeks after experimental patients must be used appropriate methods of contraception, or surgery sterilization; 7. Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion criteria

Exclusion criteria: 1. Symptomatic brain metastases (Patients who have no symptoms and is not needed to receive therapy before 21 days may participate in this trial, but need to be confirmed by MRI\CT or venography that no hematencephalon symptom); 2. Uncontrolled hypertension(systolic pressure = 140 mmHg and/or diastolic pressure = 90 mm Hg) even though two or more than two hypotensive agents application; 3. Patients who suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias.Grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%; 4. Coagulation disfunction.or Known inherited and acquired hemorrhagic and thromboplastic possibility; 5. Within 4 weeks of major surgery and/or injures, fractures, ulceration; 6. Significant factors that influence the ingestion and absorption of medicine (Such as unable to swallow, chronic diarrhea and intestinal obstruction); 7. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess = 6 months; 8. Urine protein=++, or 24h urine protein quantitation=1.0g; 9. History of psychiatric drugs abuse and not be abstinent, or dysphrenia; 10. Pregnant or lactating women; Patients with fertility unwilling or unable to take effective contraceptive measures; 11. Other conditions regimented at investigators' discretion.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
OS;DCR;ORR;QoL;Drug safety;

Countries

China

Contacts

Public ContactZhou Li

Xinan Hostipal, Chongqing

lr543810125@163.com+86 18584666264

Outcome results

None listed

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