Efficacy and safety of apatinib in the treatment of recurrent or metastatic cervical cancer patients

• Register: ChiCTR
• Last refreshed on: 18 June 2018
• Main ID: ChiCTR1800016676
• Date of registration: 2018-06-15
• Prospective Registration: No
• Primary sponsor: Fudan University Shanghai Cancer Center
• Public title: Efficacy and safety of apatinib in the treatment of recurrent or metastatic cervical cancer patients
• Scientific title: Efficacy and safety of apatinib in the treatment of recurrent or metastatic cervical cancer patients
• Date of first enrolment: 2018-06-01
• Target sample size: Case series:23;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=28334
• Study type: Observational study
• Study design: Case series
• Phase: II (Phase II study)

Countries of recruitment

China

Contacts

• Name: ZHU JUN
• Affiliation: Fudan University Shanghai Cancer Center

• Name: WU XIAOHUA
• Affiliation: Fudan University Shanghai Cancer Center

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged=18years;
2. ECOG performance status 0 - 2;
3. Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix;
4. Patients who have received second-line or above treatment in the past and have made progress, and have not received targeted treatment, or advanced patients who cannot receive surgery, radiotherapy and chemotherapy due to physical reasons;
5. Measurable lesion;
6. Estamated survival = 3 months;
7. WBC >=3.0 x 10^9/L and ANC >=2.0 x 10^9/L; Platelets >=100 x 10^9/L; Bilirubin <=1.5 x ULN; AST or ALT <=2.5 x ULN; 5. Adequate renal function: creatinine <=ULN (CTC Grade 0) or calculated creatinine clearance (Cockcroft-Gault Formula) >=60ml/min or >=50 ml/min by EDTA creatinine clearance;
8. Written informed consent;
9. Good compliance, the family agreed to cooperate with survival follow-up.
Exclusion criteria: 1. With other malignant tumor, except those that have been cured or stabilized;
2. Women who is pregnant or breastfeeding;
3. Participated in clinical trials of other drugs within one month;
4. A variety of factors (such as inability to swallow, chronic diarrhea, and intestinal obstruction) that affect oral medications;
5. Any bleeding event of severe grade up to 3 or more in CTCAE4.0 within 4 weeks prior to screening;
6. Patients with a known history of central nervous system metastasis or central nervous system metastasis were screened;
7. Patients with hypertension who cannot obtain good control through single hypotensive therapy (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); Having a history of unstable angina; New diagnosis of angina within 3 months prior to screening or myocardial infarction within 6 months prior to screening; Arrhythmias (including QTcF) require long-term use of antiarrhythmic drugs and New York heart association grade II or greater;
8. A long unhealed wound or incomplete fracture;
9. A history of organ transplantation;
10. Imaging studies have shown that the tumor has invaded important blood vessels or that the patient's tumor is highly likely to invade important blood vessels during treatment and cause fatal hemorrhage;
11. Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L), with bleeding tendency (14 days before randomization must be met: INR is within the normal range without anticoagulants). Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; International standardization in prothrombin time ratio (INR) under the premise of 1.5 or less, allowing purpose to prevent the use of low-dose warfarin (1 mg orally, once per day) or low-dose aspirin (amount does not exceed 100 mg daily);
12. Screening move/vein thrombosis incidents happened in the year before, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (line by chemotherapy venipuncture vein thrombosis by researchers have judgment recovered except) and pulmonary embolism, etc;
13. Having a history of psychotropic substance abuse and cannot be cured or having a mental disorder;
14. A history of immunodeficiency, other acquired, congenital immunodeficiency disorders, or a history of organ transplantation;
15. According to the judgment of the researchers, there is serious harm to the patient's safety or the accompanying diseases that affect the patient's completion of the study.

Age minimum: 18
Age maximum: 70
Gender: Female

Health Condition(s) or Problem(s) studied

Cervical Cancer

Intervention(s)

Case series:Receive apatinib;

Primary Outcome(s)

ORR;

Secondary Outcome(s)

PFS;OS;

Source(s) of Monetary Support

research funds

Ethics review

Status: Approved
Approval date:
Contact:

CHEN ZHEN