Cervical Cancer
Conditions
Interventions
Group 1:TP/TC+Aapatinib
Group 2:TP/TC
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent form prior to the implementation of any trial-related processes; 2. Histopathologically confirmed cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma; 3. According to FIGO stage IVB, recurrent or persistent cervical cancer patients, can not be cured by surgery and / or radiotherapy; 4. Aged 18-70 years old; 5. There are objectively measurable lesions according to the RECIST 1.1 standard; 6. ECOG score 0-2 points; 7. Expected to survive for more than 3 months; 8. Previously not receiving systemic chemotherapy for advanced, recurrent/sustainable cervical cancer; Patients who have received concurrent chemoradiotherapy due to local advanced disease (chemotherapy during the course of radiotherapy) may participate in the study; Patients who have received platinum-assisted chemotherapy (including surgery or radiotherapy) or neoadjuvant chemotherapy have progressed to >6 months after the end of the last treatment and are eligible to participate in the study; 9. White blood cells = 3.0 × 10^9, absolute neutrophil count = 1.5 × 109, platelets = 80 × 10^9, hemoglobin = 80g/L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 ULN, serum bilirubin (TBIL) = 1.5ULN, serum creatinine = ULN or creatinine clearance = 60ml/min;
Exclusion criteria
Exclusion criteria: If the patient does not meet the inclusion criteria or if any of the following conditions occur, the patient is excluded from the study: 1. Histopathology confirmed non-cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma, if there are small cells, neuroendocrine carcinoma, sarcoma components, can not be included; 2. Known to be allergic to any drug in the study; 3. Double kidney effusion cannot be relieved by placing a ureteral stent or nephrostomy; 4. Active ulcers, intestinal perforations, intestinal obstruction; 5. Unstable angina, myocardial infarction, and grade III-IV cardiac insufficiency (NYHA criteria) occurred within 6 months prior to enrollment; 6. Those who had a history of digestive tract perforation within 28 days prior to the study; 7. There is hypertension that is uncontrollable by drugs; 8. There are active infections that cannot be controlled; 9. Those with previous peripheral neuropathy and associated symptoms; 10. There are neurological or psychiatric disorders that affect cognitive ability, including the transfer of the central nervous system; 11. History of other primary malignancies except cervical cancer (except for non-malignant melanoma of the skin).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival rate;Objective response rate;Disease control rate;Duration of response;Evaluation of safety and tolerability characteristics of apatinib combined with paclitaxel + cisplatin / carboplatin; | — |
Countries
China
Contacts
Public ContactZheng Min
Sun Yat-sen University Cancer Center
Outcome results
None listed