At a glance
ClinicalIndex Comparison Record- ✓Stage IB1 cervical cancer confirmed by gynecologic examination and MRI
- ✓Pathologically confirmed squamous cell carcinoma
- ✓Transformation zone TZ1 or TZ2
- ✓PD-L1 positive with Combined Positive Score ≥1
- ✕History of infertility or tubal/husband-related infertility
- ✕Active or prior autoimmune disease requiring systemic treatment
- ✕Prior immune checkpoint inhibitor therapy
- ✕Hypersensitivity to study medication or monoclonal antibodies
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT06289062Phase 2RecruitingUpdate OverdueUpdated 19mo ago · Completion was 7mo agoNeoadjuvant Chemotherapy Plus Camrelizumab (NACI Therapy) for Fertility Preservation in FIGO Stage IB1 Cervical Cancer
In Brief
A Phase 2 clinical trial evaluating Camrelizumab, Cisplatin, and 2 other interventions for Cervical Cancer and 2 related conditions. Currently recruiting, targeting 40 participants across 2 sites.
Signals
Detailed Summary
This multicenter, prospective clinical trial is designed to enroll PD-L1 expression-positive patients with stage IB1 cervical cancer who desire fertility preservation to undergo neoadjuvant chemotherapy in combination with a PD-1 inhibitor to evaluate the rate of complete pathologic remission, treatment-related adverse events, pregnancy rate, miscarriage rate, preterm birth rate, live birth rate, EFS and OS.
Study Details
Timeline
Interventions
Camrelizumab is administered at 200mg, q3w (second and third cycles) before radical surgery
75-80mg/m2, D1-D2，q3w (3 cycles)，intravenous infusion, administered at a rate of 1mg/min.
260 mg/m2，D1，q3w （3 cycles），intravenous infusion, administered over 30min.
cone biopsy + pelvic lymphadenectomy or Cervical biopsy + pelvic lymphadenectomy