NCT05173272

Induction Chemotherapy Combined With Immunotherapy Followed by Concurrent Chemoradiation in Advanced Cervical Cancer

A Prospective Randomized Controlled Trials of Neoadjuvant Chemotherapy Combined With Serplulimab Followed by Concurrent Chemoradiation Versus Concurrent Chemoradiation Therapy Alone in Advanced Cervical Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 286 (estimated)
• Sponsor: Sichuan Cancer Hospital and Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to determine whether neoadjuvant chemotherapy combined with slulimumab sequential concurrent chemoradiotherapy versus concurrent chemoradiotherapy for locally advanced cervical cancer could improve progression-free survival rates. Women in the experimental arm will receive neoadjuvant chemotherapy (cisplatin plus paclitaxel) combined with slulimumab every 21 days during 2 cycles followed by concurrent chemoradiation therapy. Women in the control arm will receive concurrent chemoradiation therapy alone. 286 patients will be recruited during 2 years, with 3 years of follow up period.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Neoadjuvant Therapy	Cisplatin 50 mg/m\^2 d1 q21+ Paclitaxel 175 mg/m\^2 d1 q21+serplulimab 300mg d1 q21
RADIATION	CCRT	weekly cisplatin for 4 or 5 weeks is administered concomitant with EBRT (45-50.4Gy) in 1.8-2 daily fractions and a 10-20 Gy boost to reach a total dose of 65 Gy when there was unresectable lymph nodes.
RADIATION	Brachytherapy	The primary cervical tumor is the boosted, using image guided 3D brachytherapy or 2D brachytherapy, with an additional 30-40 Gy to HRCTV (3D brachytherapy) or to point A (2D brachytherapy), to achieve a total dose of 80 Gy for small-volume cervical tumors or 85 Gy for larger-volume cervical tumors.

Timeline

• Start date: 2023-07-24
• Primary completion: 2027-12-28
• Completion: 2028-12-28
• First posted: 2021-12-29
• Last updated: 2023-12-27

Locations

1 site across 1 country: China