Neoadjuvant Chemoimmunotherapy and Extrafascial Hysterectomy for IB2 Cervical Cancer
Neoadjuvant Chemotherapy Plus Cadunilizumab Followed by Extrafascial Hysterectomy for FIGO Stage IB2 Cervical Cancer: a Multicenter, Single-arm, Phase 2 Trial.
Tongji Hospital
50 participants
Sep 3, 2024
INTERVENTIONAL
Conditions
Summary
This study is an exploratory clinical trial to investigate the feasibility of neoadjuvant chemoimmunotherapy plus extrafascial hysterectomy and pelvic lymph node dissection in patients with stage IB2 (2018 FIGO) cervical cancer and to observe the response rate to treatment, adverse effects and complications, and to assess the survival rate of patients.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
10 mg/kg (body weight), 60 min, IV. Repeat every 3 weeks for a total of 3 cycles
260 mg/m2 for 30 min. Repeat every 3 weeks for a total of 3 cycles.
75-80 mg/m2, IV, 1 mg/min. Repeat every 3 weeks for a total of 3 cycles.
Extrafascial hysterectomy + pelvic lymphadenectomy (or SLN mapping) (For participants who meet ConCerv criteria)
Radical hysterectomy + pelvic lymphadenectomy ± para-aortic lymphadenectomy (or SLN mapping) (For participants who do not meet ConCerv criteria)
Cold knife conization (CKC) (For participants with tumor size ≤2 cm after 3 cycles of chemo-immunotherapy)
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06289751