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NOT YET RECRUITING
NCT06542549
PHASE3

Efficacy and Safety of AK104 (PD-1/CTLA-4 Bispecial Antibody) Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer

Sponsor: Anhui Provincial Hospital

View on ClinicalTrials.gov

Summary

This is a randomized, controlled, single-center clinical study to evaluate AK104 in FIGO 2018 stage III-IV ovarian cancer subjects who were assessed to be at high perioperative risk and/or unable to achieve R0 resection prior to initial treatment. The efficacy and safety of neoadjuvant therapy with intravenous infusion combined with chemotherapy compared with chemotherapy alone.

Official title: Efficacy and Safety of AK104 (PD-1/CTLA-4 Bi-specific Antibody) Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer: a Randomized Controlled, Single-center Clinical Study

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-10-01

Completion Date

2030-10-31

Last Updated

2024-08-07

Healthy Volunteers

No

Interventions

DRUG

AK104

The study treatment was followed by a 3-week treatment cycle. The dosing time window is ±3 days. Within 72 hours before each dosing cycle, subjects are required to complete various examinations, including vital signs, physical examination, laboratory examination, and physical status score, to evaluate the safety and tolerability of continued treatment.