To Evaluate the Efficacy and Safety of Anlotinib Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Cervical Cancer Clinical Trial
Official title:
An Exploratory Phase II Clinical Trial of Anlotinib Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Cervical Cancer
To observe the efficacy and safety of hydrochloride anlotinib combined with concurrent radiochemotherapy for patients with FIGO stage IB3 and IIA2-IVA cervical cancer.
Subjects received "anlotinib + paclitaxel/cisplatin" induction therapy for two cycles, and then received "anlotinib + concurrent chemoradiotherapy, sequential high-dose-rate intracavitary radiotherapy, sequential chemotherapy consolidation therapy" regimen:Induction regimen:Anlotinib: 10 mg, po, qd, d1-d14, q3w, 2 consecutive cycles Paclitaxel 175mg/m2 intravenous injection for 3 hours, d1 Cisplatin 75mg/m2, iv, divided into 3 days, q3w;Unable to tolerate, nedaplatin 75mg/m2, iv, d1 can be used instead;21 days as a cycle, a total of 2 cycles Treatment programs: Anlotinib: 10 mg, po, qd, d1-d14, q3w, 2 consecutive cycles；Cisplatin: 30-35 mg/m2, iv, d1, qw, 5 consecutive cycles；Pelvic external radiation therapy: once a day, 1.8-2 Gy/time, 5 days a week, for 5 consecutive weeks, a total of 45-50 Gy sequential；High dose rate intracavitary radiotherapy: 6 Gy/time, twice a week, 5 consecutive times, a total of 30 Gy/2.5 weeks, bioequivalent dose of 40 Gy sequential；Taxane drugs: including but not limited to paclitaxel, nab-paclitaxel, paclitaxel liposome, etc. The dosage regimen is determined by the investigator;Cisplatin 75mg/m2, iv, divided into 3 days, q3w;Unable to tolerate, nedaplatin 75mg/m2, iv, d1 can be used instead;2 cycles.A total of 36 patients will be included and this study will be conducted in the department of radiation and clinical oncology in The First Affiliated Hospital of Nanjing Medical University. ;