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A prospective, exploratory, single arm and single center clinical trail to evaluate the safety and efficacy of Apatinib Mesylate Tablets or combined with chemotherapy in advanced and recurrent and persistent cervical carcinoma

A prospective, exploratory, single arm and single center clinical trail to evaluate the safety and efficacy of Apatinib Mesylate Tablets or combined with chemotherapy in advanced and recurrent and persistent cervical carcinoma

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800014253
Enrollment
Unknown
Registered
2018-01-02
Start date
2018-02-01
Completion date
Unknown
Last updated
2018-01-08

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

Conditions

cervical cancer

Interventions

Case series:apatinib mesylate monotherapy or combined with chemotherapy

Sponsors

Shandong Cancer Hospital and Institute
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged over 18 years; 2. ECOG(Eastern Cooperative Oncology Group) 0~2; 3. The treatment-naive pathologically confirmed cervical cancer; 4. The subjects received treatment of other damage has been restored (4 edition of the NCI-CTCAE classification is less than or equal to 1 grade), which underwent surgery over 4 weeks; the EGFR TKI class of molecular targeted drugs over 2 weeks; 5. The blood routine and biochemical indexes are in accordance with the following criteria:Hb=80g/L, LANC =1.5 x 10^9/L , PLT=90×10^9/L, ALT and AST<2.5 times of upper limit of normal reference value(Liver metastasis <5×ULN), Bilirubin< 1.5×ULN; SCr (serum creatinine) <1.5 times the upper limit of normal (ULN)or calculated creatinine clearance rate=45 mL/min(Cockcroft-Gault formula); 6. The Expected lifetime =3 months; 7. Participants volunteered to participate in this study, signed informed consent, compliance, with follow-up.

Exclusion criteria

Exclusion criteria: 1. patients who are allergic to lapatinib or any of the ingredients in lapatinib tablets; 2. Patients with uncontrol hypertension in the use of antihypertensive drugs (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg); 3. Patients with severe cardiovascular disease: Patients with grade II myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval =470 ms); According to NYHA standard , patients with grade III ~IV cardiac insufficiency left ventricular ejection fraction (LVEF) under 50% confirmed by echocardiography; 4. Patients with positive urinary protein; 5. The following several factors ,such as unable to swallow, chronic diarrhea and intestinal obstruction; 6. Patients with a clear tendency of gastrointestinal bleeding can not be allowed tp into the group, including the following: local active ulceration, fecal, occult blood test(++), The history of hematemesis and melena within 2 months; 7. Cagulation abnormalities. Patients with bleeding tendency, inherited or acquired bleeding tendency and thrombus tendency known to be present; 8. History of abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 month prior to study entry; 9. Accompanied by the central nervous system transfer; 10. Pregnant or lactating women; 11. Patients with a history of psychiatric drug abuse and can not be prevented or have mental disorders; 12. Participated in other drug clinical trials within four weeks; 13. Received VEGFR inhibitor, such as sorafenib sunitinib; 14. According to the researcher's judgment, there is a serious risk of compromising the patient's safety or affecting the patient's completion of the study.

Design outcomes

Primary

MeasureTime frame
PFS;Safty;OS;DCR;ORR;

Countries

China

Contacts

Public ContactLi Dapeng

Shandong Province Cancer Research Institute

drldp@126.com+86 15553115531

Outcome results

None listed

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