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

NCT05173272 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2023-12-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Sichuan Cancer Hospital and Research Institute

    lead OTHER

Principal Investigators

  • Guonan Zhang · Sichuan Cancer Hospital and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-24
Primary Completion
2027-12-28
Completion
2028-12-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05173272 on ClinicalTrials.gov