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Apatinib and chemotherapy sequential treatment with cervical cancer

A Phase II Clinical Trial Study on Apatinib and chemotherapy sequential treatment with advanced metastatic cervical cancer

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-17010463
Enrollment
Unknown
Registered
2017-01-18
Start date
2017-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

cervical cancer

Interventions

Test Group:Apatinib 250 mg qd, po
standard chemotherapy

Sponsors

Daping Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 25 ~ 75 years old; 2. The pathological diagnosis of recurrent or metastatic cervical cancer; 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1; 4. Life expectancy of more than 3months; 5. With normal marrow, liver and renal function blood routine examination (without blood transfusion during 14 daysunused g-csf and other hematopoietic stimulating factor correct): HB=90g/L, ANC =1.5×10^9/L, PLT =80×10^9/L. Biochemical examination: a total bilirubin (TBil) of =1.5 upper normal limitation (UNL); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of =2.5 UNL or =5 UNL in case of liver metastasis; a creatinine (Cr) of = 1.25 UNL; a creatinine clearance rate = 45ml/min (Cockcroft-Gault); 6. With written informed consent signed voluntarily by patients themselves. With good compliance and agree to accept follow-up of disease progression and adverse events.

Exclusion criteria

Exclusion criteria: 1. Uncontrolled hypertension; 2. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias; 3. With abnormal coagulation function bleeding tendency or treating with thrombolysis and anticoagulation; 4. History of clinically relevant major bleeding event (e.g. gastrointestinal hemorrhage, bleeding ulcer, occult blood = (++), and vasculitis) =++, or urine protein in 24 hours> 1.0g; 9. Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment; 10. History of uncontrolled psychotropic drug abuse or mental disorders; 11. Prior VEGFR inhibitor treatment; 12. Other malignancy within Before or at the same time other than basal cell skin cancer, or carcinoma in situ of the cervix.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
OS;ORR;DCR;Safety;

Countries

China

Contacts

Public ContactFeng Jin

Daping Hospital

wanggedaping@163.com+86 13908315698

Outcome results

None listed

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