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

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Start date: Jun 1, 2023 to Jul 24, 2023v7
  2. Start date: Apr 24, 2023 to Jun 1, 2023v6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 28, 2022 to Apr 24, 2023
    • Site details revised
    v5
  4. Start date: Sep 1, 2022 to Dec 28, 2022
    • Primary completion date: Sep 28, 2027 to Dec 28, 2027
    • Study completion date: Sep 28, 2028 to Dec 28, 2028
    v4
  5. Primary completion date: Feb 28, 2027 to Sep 28, 2027v3 Show 5 more changesShow less
    • Start date: Mar 1, 2022 to Sep 1, 2022
    • Study completion date: Feb 28, 2028 to Sep 28, 2028
    • Interventions: Brachytherapy (Radiation), CCRT (Radiation), NACT (Drug) to Brachytherapy (Radiation), CCRT (Radiation), Neoadjuvant Therapy (Drug)
    • Eligibility criteria expanded, about 15 words
    • Study title expanded, about 3 words
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05173272
Lead Sponsor Sichuan Cancer Hospital and Research Institute
Conditions
(from sponsor)		 Cervical Cancer
Related terms Uterine Cervical Neoplasms
Enrollment 286 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov