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RECRUITING
NCT06289062
PHASE2

Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

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.

Official title: Neoadjuvant Chemotherapy Plus Camrelizumab (NACI Therapy) for Fertility Preservation in FIGO Stage IB1 Cervical Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-05-08

Completion Date

2030-12-01

Last Updated

2024-11-05

Healthy Volunteers

No

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

Locations (2)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

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

Wuhan, Hubei, China