RecruitingPhase 2NCT06209294

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

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)


Sponsor

Xiaohua Wu

Enrollment

30 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving immunotherapy (AK104) plus chemotherapy before surgery can shrink cervical cancer tumors enough to allow fertility-preserving surgery (keeping the uterus) instead of a full hysterectomy. It targets young women with locally advanced cervical cancer who wish to have children in the future. **You may be eligible if...** - You are between 18 and 45 years old - You have confirmed stage IB2 or IB3 cervical cancer (squamous cell, adenocarcinoma, or adenosquamous) - Your cancer has not spread beyond the cervix and there are no distant metastases - You have not received any prior cancer treatment - You wish to preserve fertility **You may NOT be eligible if...** - Your cancer has spread beyond the cervix or to distant organs - You have received prior surgery, radiation, or chemotherapy for cervical cancer - You have autoimmune conditions that prevent immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAK104

AK104(10 mg/kg) d1,22

DRUGCarboplatin

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

DRUGNab paclitaxel

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


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06209294


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