Neoadjuvant Chemoimmunotherapy and Extrafascial Hysterectomy for IB2 Cervical Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 3, 2024

Primary Completion Date

March 1, 2026

Study Completion Date

January 1, 2031

Conditions
Cervical CancerNeoadjuvant ChemoimmunotherapyRadical HysterectomyExtrafascial 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)

Trial Locations (2)

250012

RECRUITING

Qilu Hospital of Shandong University, Jinan

430030

RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

All Listed Sponsors
collaborator

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

OTHER

collaborator

Women's Hospital School Of Medicine Zhejiang University

OTHER

collaborator

Southwest Hospital, China

OTHER

collaborator

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

OTHER

collaborator

Sichuan Cancer Hospital and Research Institute

OTHER

collaborator

Qilu Hospital of Shandong University

OTHER

collaborator

Beijing Friendship Hospital

OTHER

collaborator

Tianjin Medical University

OTHER

collaborator

West China Second University Hospital

OTHER

collaborator

Xiangya Hospital of Central South University

OTHER

collaborator

Gansu Provincial Maternal and Child Health Care Hospital

OTHER

collaborator

Zhejiang Cancer Hospital

OTHER

collaborator

Shengjing Hospital

OTHER

lead

Tongji Hospital

OTHER