Actively Recruiting
Study of Chemoradiotherapy with Albumin-Bound Paclitaxel and Cisplatin Followed by PD-1 Inhibitor Sintilimab in Women with Locally Advanced Cervical Cancer
Led by RenJi Hospital · Updated on 2024-04-30
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a treatment combining Albumin-Bound Paclitaxel and cisplatin chemotherapy with radiotherapy, followed by a PD-1 inhibitor called Sintilimab, in patients with locally advanced cervical cancer. This prospective trial aims to explore how well this combined approach works and its safety profile in this patient group. Participants will receive weekly doses of Albumin-Bound Paclitaxel 50-75 mgm2 and cisplatin 25-40 mgm2 for up to five weeks during radical radiation therapy, which includes external beam radiation followed by brachytherapy. After completing chemoradiotherapy, patients will receive Sintilimab 200 mg every three weeks for eight cycles as an immunotherapy treatment. During the study, participants will be closely monitored for disease progression and treatment safety for up to two years. Researchers will assess progression-free survival, objective response rate three months after treatment, and distant-metastasis-free survival. Safety evaluations will continue for one year, with regular clinical visits, laboratory tests, and assessments to track treatment effects and patient health.
CONDITIONS
Brief Title
Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor in Advanced Cervical Cancer
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