Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC

Sponsor
Tongji Hospital
Study ID
NCT06288373
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Cervical Cancer
  • Concurrent Chemoradiotherapy
  • Locally Advanced Cervical Cancer
  • Neoadjuvant Chemoimmunotherapy

Eligibility Criteria

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

Interventions

  • Camrelizumab — DRUG
    Camrelizumab is administered at 200mg, q3w (second and third cycles) before radical surgery
  • Cisplatin — DRUG
    Cisplatin：75-80mg/m2, D1-D2，q3w (3 cycles)，intravenous infusion, administered at a rate of 1mg/min.
  • Nab paclitaxel — DRUG
    Nab paclitaxel: 260 mg/m2，D1，q3w （3 cycles），intravenous infusion, administered over 30min.
  • Radical surgery — PROCEDURE
    Radical surgery
  • external beam radiation therapy (EBRT) + brachytherapy — RADIATION
    Radiation therapy per standard of care
  • Cisplatin — DRUG
    Chemotherapy administered concurrent with radiation therapy，cisplatin 40 mg/m2 IV once per week (QW) for 5 weeks

Study Details

It is a prospective, open-label, randomized, controlled phase II/III clinical trial in which patients with PD-L1-positive FIGO stage IB3, IIA2 and IIB（tumors \>4 cm in diameter）will be enrolled and randomly divided into the neoadjuvant chemoimmunotherapy plus surgery group and the CCRT group.

Key Dates

Start date
Apr 22, 2024
Status verified
Oct 2024
Primary completion
Mar 1, 2031
Completion
Mar 1, 2031

Study Design

Enrollment
440 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab combined neoadjuvant chemotherapy plus radical surgery
    Patients receive 1 cycle of cisplatin and nab paclitaxel combined neoadjuvant chemotherapy and subsequent 2 cycles of camrelizumab combined neoadjuvant chemotherapy. Based on the tumor size as indicated by MRI, patients who achieve complete response or partial response (CR/PR，RECIST v1.1) will undergo open radical hysterectomy and pelvic lymph node dissection. Patients who show stable disease or progression (SD/PD，v1.1) will proceed directly to concurrent chemoradiotherapy (CCRT).
  • Active Comparator: Concurrent Chemoradiotherapy (CCRT)
    Pelvic EBRT + concurrent platinum-containing chemotherapy + brachytherapy

Primary Outcome Measure

Progression-free survival, PFS [ Time Frame: 7 years ]

Central Contacts

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