Neoadjuvant Immunochemotherapy in PD-L1-negative LACC

Sponsor
Tongji Hospital
Study ID
NCT06288360
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cervical Cancer
  • Locally Advanced Cervical Cancer
  • Neoadjuvant Chemoimmunotherapy
  • PD-L1 Negative

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    200 mg, intravenously, 20-60 min. 2 times, every 21 days
  • Paclitaxel-albumin — DRUG
    260 mg/m² over 30 min, 3 times, every 21 days
  • Cisplatin — DRUG
    4 h, 75-80 mg/m², 3 times, every 21 days
  • radical surgery — PROCEDURE
    Radical hysterectomy + pelvic lymphadenectomy 士 para-aortic lymphadenectomy

Study Details

This is a multicenter, prospective, single-arm, phase 2 clinical trial designed to evaluate the therapeutic efficacy of the NACI (neoadjuvant chemotherapy plus Camrelizumab) for PD-L1-negative locally advanced cervical cancer.

Key Dates

Start date
Sep 12, 2024
Status verified
Oct 2024
Primary completion
Dec 31, 2025
Completion
Dec 12, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant chemotherapy plus camrelizumab (NACI)
    Patients first received one cycle of platinum-based doublet priming chemotherapy. After 3 weeks, participants received two cycles of the PD-1 inhibitor camrelizumab combined with chemotherapy every 3 weeks. Patients with stable disease or progressive disease received concurrent chemoradiotherapy, and patients with a complete response or partial response proceeded to radical surgery.

Primary Outcome Measure

Pathologic complete response [ Time Frame: undergoing surgery; up to 2 years. ]

Central Contacts

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