Actively Recruiting
Neoadjuvant Chemoimmunotherapy With Surgery Compared to Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer in Women Ages 18 to 70
Led by Tongji Hospital · Updated on 2024-10-30
440
Participants Needed
12
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating treatment options for locally advanced cervical cancer LACC in patients with PD-L1-positive tumors larger than 4 cm. This trial compares neoadjuvant chemoimmunotherapy followed by surgery against the current standard treatment of concurrent chemoradiotherapy CCRT. The study aims to assess differences in clinical outcomes and side effects between these two approaches to provide better evidence for neoadjuvant immunotherapy use in cervical cancer. Participants will be randomly assigned to one of two groups. One group receives one cycle of cisplatin and nab paclitaxel chemotherapy combined with two cycles of camrelizumab before surgery. Patients who respond well will undergo radical hysterectomy and lymph node removal, while those with stable or progressing disease will receive CCRT. The other group will receive pelvic external beam radiation therapy plus weekly cisplatin chemotherapy and brachytherapy as standard care. Throughout the study, participants will be monitored with imaging to assess tumor response and will undergo various evaluations including physical exams, laboratory tests, and quality of life questionnaires. Researchers will track progression-free survival and objective response rate as primary outcomes, with additional measures such as overall survival, surgical complications, and treatment safety followed for up to seven years. The trial includes long-term follow-up to assess physical function and symptom changes over time.
CONDITIONS
Brief Title
Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC
Research Team
K
Kezhen Li
J
Jing Chen
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