This study aims to evaluate the efficacy and safety of Tislelizumab combined with concurrent chemoradiotherapy in the treatment of cervical cancer patients with cervical mass \> 4cm and regional lymph node metastasis, paracervical invasion and regional lymph node metastasis, stage IIIA, stage IIIB, and stage IVA. To provide a clinical reference for finding a safe and effective individualized treatment plan to improve the survival prognosis of locally advanced cervical cancer patients.
This is a prospective, single-arm, single-center phase II clinical study. The objective is to evaluate the efficacy and safety of Tislelizumab combined with concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer. This study was independently completed by our center. Cervical cancer patients with cervical mass \> 4cm with regional lymph node metastasis, paracervical invasion with regional lymph node metastasis, stage IIIA, stage IIIB and stage IVA in FIGO stage 2018 were selected as subjects, and 30 patients were planned to be enrolled. External irradiation 45\~50Gy/25f+ Brachytherapy 28\~30Gy/4\~5f; Chemotherapy: DDP 40mg/m2/W, synchronous with radiotherapy, complete at least 4 cycles; Tislelizumab: 200mg/3W for 1 year or disease progression or intolerable toxicity, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Tislelizumab injection\[10ml:100mg\] will be used beginning with radiotherapy: 200mg/3W for 1 year or disease progression or intolerable toxicity, whichever occurs first.
DDP 40mg/m2/W, synchronous with radiotherapy, complete at least 4 cycles.
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
RECRUITINGTumor regression ratio
The tumor regression ratio after external irradiation, MRI/CT will be used for evaluating the carcinoma status.
Time frame: 2 weeks
Overall Response Rate
The overall response rate or tumor after radiotherapy and chemotherapy, and MRI/CT will be used for evaluating the carcinoma status.
Time frame: 3 months, 6 moths
Overall Survival
OS was calculated from the date of entry into the study to the date of death or the last follow-up visit.
Time frame: 1 years, 3 years
Progression Free Survival
PFS was calculated from the date of entry into the study to the date of first physical or radio-graphic evidence of disease progression, death or the last follow-up visit.
Time frame: 1 years, 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.