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RECRUITING
NCT06209294
PHASE2

Phase II Study on Neoadjuvant Therapy of AK104 Combined With Nab-paclitaxel/Carboplatin in Fertility Preserving Surgery

Sponsor: Xiaohua Wu

View on ClinicalTrials.gov

Summary

This is a Phase II study of neoadjuvant therapy of AK104 combined with nab-paclitaxel/carboplatin in fertility saving surgery for stage IB2-IB3 cervical cancer (FIGO 2018). The main questions it aims to answer are: * · Evaluate the safety of AK104 combined with nab-paclitaxel/carboplatin in the neoadjuvant treatment of cervical cancer * · Evaluate the tumor regression and Major Pathological Response(MPR) of AK104 combined with nab-paclitaxel/carboplatin as neoadjuvant therapy for cervical cancer.

Official title: Phase II Study on Neoadjuvant Therapy of AK104 Combined With Nab-paclitaxel/Carboplatin in Fertility Preserving Surgery for Stage IB2-IB3 Cervical Cancer (FIGO 2018)

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-09-01

Completion Date

2028-12-30

Last Updated

2024-01-17

Healthy Volunteers

No

Interventions

DRUG

AK104

AK104(10 mg/kg) d1,22

DRUG

Carboplatin

AUC=2 d1,8,15,22, 29, 36

DRUG

Nab paclitaxel

125mg/m2 d1,8,15,22,29,36

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China