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The Efficacy and Safety of Apatinib as Second-line for Advanced Recurrent Cervical Cancer (AARCA)

Apatinib for Advanced Recurrent Cervical Cancer Cooperative Group

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-OIN-17012164
Enrollment
Unknown
Registered
2017-07-27
Start date
2017-07-31
Completion date
Unknown
Last updated
2020-05-04

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

Conditions

Advanced recurrent cervical cancer

Interventions

Apatinib:Apatinib
Control group:Suportive treatment

Sponsors

Affiliated Hospital of Zunyi Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Histologically or radiography diagnosed cervical cancer 2. Accroding to RECIST 1.1, there is at least one measurable lesion 3. The patient, who previous first-line standard chemotherapy regimen failed or relapsed, and the time interval for the end of the chemotherapy was at least 4 weeks to included. 4. The duration of the previous surgical operation was at least 4 weeks 5.Age between 18-70 6.Performance status; EGOG PS :0-2 7. The overall survival = 3 months 8. Normal hematological, hepatic, nephrologic function WBC = 4000 cells/mm3 Platelet = 100,000 /mm3 Hemoglobin = 8.0 gm/dL Serum creatinin = 1.3 mg/dL Serum bilirubin = 1.5 mg/dL SBOT/SGPT and Alkaline phoaphatase < normal X 3 9. Patient with informed consent

Exclusion criteria

Exclusion criteria: 1. patients who were allergic to Apatinib and/or its excipients 2. patients with hypertension and antihypertensive drug treatment can not drop to normal range (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with level-I above coronary heart disease, arrhythmia in class I (including QTc duration > 470 ms) and the grade I cardiac insufficiency; 3. Various factors that affect oral administration (such as inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.) 4. Patients with clear bleeding tendencies, including: localized active ulcer lesions, and fecal occult blood (+ +) are not included in the group;Within 2 months, the history of black, hematemesis and so on; 5. radiography shows that the tumor has invaded an important blood vessel or has been judged by the researchers to be highly likely to attack important blood vessels during the treatment period. 6. Abnormal coagulation function (INR > 1.5, APTT > 1.5 ULN), or bleeding tendency; 7. Patients with HIV infection; 8. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months prior to entry; 9. patient with a positive urinary protein; 10. Patients with a history of psycho-drug abuse or could not quit or have mental disorders; 11. Psychiatric problems 12. Pregnant or breast feeding status 13. Legally unable to participate clinical trial 14. When there is a Doctor's decision that patient is unable to participate clinical trial

Design outcomes

Secondary

MeasureTime frame
adverse effect;DCR;

Primary

MeasureTime frame
PFS;OS;Obejective response rate;

Countries

China

Contacts

Public ContactHang Zhou

Affiliated Hospital of Zunyi Medical University

jianguo.zhou@yahoo.com+86 0851-28608869

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 5, 2026