Neoadjuvant Chemoimmunotherapy and Extrafascial Hysterectomy for IB2 Cervical Cancer

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.

Conditions

• Cervical Cancer
• Neoadjuvant Chemoimmunotherapy
• Radical Hysterectomy
• Extrafascial Hysterectomy

Interventions

DRUG

Cadonilimab

10 mg/kg (body weight), 60 min, IV. Repeat every 3 weeks for a total of 3 cycles

DRUG

Paclitaxel-albumin

260 mg/m2 for 30 min. Repeat every 3 weeks for a total of 3 cycles.

DRUG

Cisplatin

75-80 mg/m2, IV, 1 mg/min. Repeat every 3 weeks for a total of 3 cycles.

PROCEDURE

Extrafascial hysterectomy

Extrafascial hysterectomy + pelvic lymphadenectomy (or SLN mapping) (For participants who meet ConCerv criteria)

PROCEDURE

Radical hysterectomy

Radical hysterectomy + pelvic lymphadenectomy ± para-aortic lymphadenectomy (or SLN mapping) (For participants who do not meet ConCerv criteria)

PROCEDURE

Cone biopsy

Cold knife conization (CKC) (For participants with tumor size ≤2 cm after 3 cycles of chemo-immunotherapy)

Sponsors & Collaborators

• The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)

  collaborator OTHER

• Women's Hospital School Of Medicine Zhejiang University

  collaborator OTHER

• Southwest Hospital, China

  collaborator OTHER

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

  collaborator OTHER

• Sichuan Cancer Hospital and Research Institute

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Beijing Friendship Hospital

  collaborator OTHER

• Tianjin Medical University

  collaborator OTHER

• West China Second University Hospital

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Gansu Provincial Maternal and Child Health Care Hospital

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• Shengjing 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

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-03

Primary Completion

2026-03-01

Completion

2031-01-01

Countries

• China

Study Locations