NCT07104149

Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer

Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer : a Multicentre, Single Arm, Phase 2 Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Main Purpose of this study is to determine the efficacy and safety of Cadonilimab combined with chemotherapy (cisplatin) for locally advanced cervical cancer. This is an multicentre, single Arm, Phase 2 Trial study of Cadonilimab with Cisplatin in the treatment of locally advanced cervical cancer. 29 eligible patients will receive Cadonilimab（10mg/kg, iv., D1, q3w）with Cisplatin ( 75mg/ m2, iv., D2， q3w) for a total of 2-4 cycles before radical surgical treatment.

Detailed description

Detailed Description: Study Title : Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer : a Multicentre, Single Arm, Phase 2，prospective Trial Main Study Objectives : Determine the efficacy and safety of Cadonilimab combined with chemotherapy (cisplatin) for locally advanced cervical cancer. Secondary Objective: Explore the correlations between the expression of PD-L1 , Tumor Mutational Burden（TMB） levels, immune cell subsets, tumor microenvironment and therapeutic efficacy Study Endpoints : Primary Endpoint :Pathological complete response rate (pCR) and Radiological response rate (RS) Secondary Endpoints :Safety (Incidence and severity of adverse events (AE) caused by drug treatment and perioperative complications, clinically significant abnormal laboratory test results;Clinical downstaging rate (downstaging of T and/or N); Major pathological response rate (MPR);Disease-free survival (DFS); Objective response rate (ORR) ,Disease control rate (DCR), progression-free survival (PFS), and 5-year overall survival rate (OS) based on RECIST v1.1 and mRECIST evaluation. Target Population : Patients with histologically confirmed cervical cancer , stage IB3, IIA2, IIB, and IIIC according to FIGO , and the lesion was resectable . Study Drug and Administration . 29 eligible patients will receive Cadonilimab（10mg/kg, ivgtt., D1, q3w）with Cisplatin ( 75mg/ m2, ivgtt., D2，q3w) for a total of 2-4 cycles before radical surgical treatment. Dose adjustments are not allowed during the treatment ,Treatment may be delayed for a maximum of 12 weeks from the previous treatment. Imaging examinations were conducted to evaluate the efficacy of neoadjuvant therapy and the possibility of radical resection. Radical surgery for cervical cancer was then performed. The study investigators would determine whether adjuvant therapy was necessary and select an appropriate treatment plan (the first treatment was initiated 6 weeks ± 2 weeks after surgery and could not exceed 3 months). Imaging evaluations were conducted every three months after surgery until disease recurrence. Survival follow-up was performed every three months after disease recurrence. Safety visit: From the first administration of medication to 60 days after the last administration or the initiation of new anti-tumor treatment.

Conditions

• Female, Age ≥ 18 Years Old
• No Previous Systemic Treatment for the Current Disease, Including Surgery, Antitumor Radiochemotherapy/Immunotherapy
• ECOG Score of 0-1
• Histologically Confirmed Cervical Cancer, FIGO Stage IB3, IIA2, IIB, IIIC, and Assessed by the Researcher as Resectable Lesion
• Sufficient Organ Function
• The Result of the Urine or Serum Pregnancy Test for the Subject is Negative
• Subjects Should Take Contraceptive Measures
• Locally Advanced Cervical Cancer
• Expected Survival Time >6 Months

Interventions

Type	Name	Description
DRUG	Cadonilimab combined with cisplatin	Neoadjuvant chemotherapy plus cadonilimab for locally advanced cervical cancer

Timeline

• Start date: 2025-03-10
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2025-08-05
• Last updated: 2025-08-05

Locations

1 site across 1 country: China