NCT04772001

Concurrent Radiochemotherapy Plus Anlotinib for Locally Advanced Cervical Cancer

Clinical Study of Hydrochloride Anlotinib Combined With Concurrent Radiochemotherapy for Locally Advanced (Stage IB3 and IIA2-IVA) Cervical Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Zhongnan Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To observe the efficacy and safety of hydrochloride anlotinib combined with concurrent radiochemotherapy for patients with FIGO stage IB3 and IIA2-IVA cervical cancer. Patient characteristics, image and genetic information of tumor, microbial sample of tumor microenvironment and biomarker in the blood sample will be collected and analysis by multi-omics and bioinformatic technology. Aim to provide a new treatment module for cervical cancer.

Detailed description

Patients diagnosed pathologically as cervical cancer (squamous carcinoma, adenocarcinoma or adenosquamous carcinoma) with stage of FIGO IB3 and IIA2 to IVB will be included in this study according to the prescribed criteria in the protocal. Classical radiochemotherapy will be conducted by clinical routine method. Radiation will be given by external beam radiation of 45Gy total dose and 3D-brachytherapy of 30Gy/5F or 28Gy/4F. Duration of radiotherapy will be no more than 8 weeks. Concurrent chemotherapy will be administrated weekly during radiation for a total of 5-6 doses. Cisplatin of 40mg/m2 will be the most preferred regime and for patients with intolerable toxicity of cisplatin, carboplatin of AUC 2 will be the alternative drug. Apart from that, hydrochloride anlotinib, a multiple targets anti-angiogenesis kinase approved by CFDA, will be orally taken daily at a dose of 12mg for 14 days aiming to improve tumor response. Then rest for 7 days and start a new cycles for a total of 3 cycles. First capsule of anlotinib will be taken 7 days before the first radiation. Once the treatment is finished, patients will be examination for tumor evaluation and toxicity monitor every 3 months for the first 2 years and then every half years for the third year unless progression or death. During those period, patient characteristics, image data, tumor tissue, blood, urine, stool and microbial sample of tumor micro environment will be collected and analysis by multi-omics and bioinformatic technology. A total of 53 patients will be included and this study will be conducted in the department of radiation and clinical oncology in Zhongnan Hospital of Wuhan University.

Conditions

• Uterine Cervical Neoplasms
• Chemoradiotherapy
• Angiogenesis

Interventions

Type	Name	Description
DRUG	Hydrochloride anlotinib	Hydrochloride anlotinib is a small molecular anti-angiogenesis drug with multiple targets. It will be taken at a starting dose of 12 mg for 14 days. Then participants will rest for 7 days and start a new cycles. At most of 3 cycles will be administrated. If intolerable toxicity happen, dosage of 10mg or 8mg will be taken.
DRUG	cis Platinum/carboplatin	Concurrent chemotherapy will be administrated weekly during radiation for a total of 5-6 doses. Cisplatin of 40mg/m2 will be the most preferred regime. For patients with intolerable toxicity of cisplatin, carboplatin of AUC 2 will be the alternative drug.
RADIATION	External beam radiotherapy and brachytherapy	Radiation will be given by external beam of 45Gy total dose and 3D-brachytherapy of 30Gy/5F or 28Gy/4F. Duration of radiotherapy will be no more than 8 weeks.

Timeline

• Start date: 2021-03-12
• Primary completion: 2025-10-01
• Completion: 2026-01-01
• First posted: 2021-02-25
• Last updated: 2022-05-18

Locations

1 site across 1 country: China