Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer

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.

Conditions

• Cervical Cancer
• Neoadjuvant Chemoimmunotherapy
• Fertility Preservation

Interventions

DRUG

Camrelizumab

Camrelizumab is administered at 200mg, q3w (second and third cycles) before radical surgery

DRUG

Cisplatin

75-80mg/m2, D1-D2，q3w (3 cycles)，intravenous infusion, administered at a rate of 1mg/min.

DRUG

Nab paclitaxel

260 mg/m2，D1，q3w （3 cycles），intravenous infusion, administered over 30min.

PROCEDURE

biopsy

cone biopsy + pelvic lymphadenectomy or Cervical biopsy + pelvic lymphadenectomy

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• Women's Hospital School Of Medicine Zhejiang University

  collaborator OTHER

• Third Military Medical University

  collaborator OTHER

• Beijing Friendship Hospital

  collaborator OTHER

• Sichuan Cancer Hospital and Research Institute

  collaborator OTHER

• Tianjin Medical University

  collaborator OTHER

• West China Second University Hospital

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Gansu Cancer Hospital

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• Anhui Provincial Cancer Hospital

  collaborator OTHER

• Tongji Hospital

  lead OTHER

Principal Investigators

• Ding Ma · Tongji Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-08

Primary Completion

2025-12-01

Completion

2030-12-01

Countries

• China

Study Locations