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Induction Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Summary
This is an investigator-initiated, single-arm, phase II clinical study evaluating the efficacy and safety of cadonilimab combined with induction chemotherapy followed by concurrent chemoradiotherapy (CCRT) in patients with locally advanced cervical cancer (LACC). Despite standard concurrent chemoradiotherapy, patients with LACC remain at high risk of recurrence and distant metastasis. Cadonilimab, a PD-1/CTLA-4 bispecific antibody, has demonstrated promising antitumor activity in cervical cancer. This study aims to investigate whether induction immunochemotherapy with cadonilimab combined with cisplatin and albumin-bound paclitaxel can improve tumor response before definitive radiotherapy. In addition, the study will explore the association between treatment efficacy and dynamic changes in PD-L1 expression, peripheral blood immune-related biomarkers, and tumor microenvironment immune cell populations during treatment. The primary endpoint is objective response rate (ORR) assessed according to RECIST version 1.1, while secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.
Official title: Induction Chemotherapy Plus Cadonilimab Followed by Chemoradiotherapy for Locally Advanced Cervical Cancer: A Multicenter, Open-label, Single-arm, Phase II Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
29
Start Date
2024-01-23
Completion Date
2029-04-30
Last Updated
2026-06-04
Healthy Volunteers
No
Conditions
Interventions
Cadonilimab
Cadonilimab will be administered intravenously in combination with cisplatin and albumin-bound paclitaxel as induction immunochemotherapy for 2 cycles.
Cisplatin
Cisplatin will be administered during induction chemotherapy and weekly during concurrent chemoradiotherapy.
Albumin-Bound Paclitaxel /nab-Paclitaxel
Albumin-bound paclitaxel will be administered intravenously in combination with cadonilimab and cisplatin during induction therapy.
Concurrent chemoradiotherapy
External beam radiotherapy will be delivered using 6-MV X-rays at a total dose of 45-60 Gy in 25 fractions, followed by brachytherapy at a dose of 30 Gy in 5 fractions. Weekly cisplatin (30-40 mg/m²) will be administered concurrently during radiotherapy.
Locations (1)
Sun Yat-sen Memorial hosipital
Guangzhou, Guangdong, China