This study explores the therapeutic effect of carbon ion radiotherapy plus immunotherapy and chemotherapy for locally advanced cervical cancer.
The primary objective of this study is to explore whether carbon ion radiotherapy combined with immunotherapy and chemotherapy can improve the 2-year progression-free survival (PFS) of patients with locally advanced cervical cancer (Stage IIB-IVA). The secondary objectives are to investigate whether this regimen can improve the 2-year overall survival (OS) of patients with locally advanced cervical cancer, and to evaluate the adverse events associated with carbon ion radiotherapy combined with immunotherapy and chemotherapy based on RTOG and CTCAE criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Immunotherapy: Anti-PD-1 therapy administered once every 3 weeks starting at radiotherapy initiation, with a total maintenance duration of 2 years. Chemotherapy: Weekly concurrent single-agent cisplatin (dose: 40 mg/m² per week) or carboplatin (target AUC = 2) is given simultaneously with carbon ion external beam radiotherapy for a total of 4 cycles.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGProgression-free survival (PFS)
This endpoint is determined based on investigators' assessments per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). If disease progression cannot be confirmed by imaging according to RECIST 1.1, progressive disease (PD) histopathologically verified following carbon ion radiotherapy combined with three-dimensional brachytherapy, concurrent chemotherapy and immunotherapy shall serve as the criterion for progression determination.
Time frame: At 2 years after the start of trial treatment
Overall survival (OS)
To evaluate the 2-year overall survival rate of patients treated with carbon ion radiotherapy plus three-dimensional intracavitary brachytherapy combined with concurrent chemotherapy and immunotherapy. Death from any cause is defined as the endpoint event. Subjects who remain alive or are lost to follow-up at the data cut-off date will be treated as censored data.
Time frame: At 2 years after the start of trial treatment
Acute and late toxicities
To evaluate acute and late toxicities of carbon ion radiotherapy plus three-dimensional intracavitary brachytherapy combined with concurrent chemotherapy and immunotherapy, graded per RTOG and CTCAE criteria.
Time frame: Acute toxicities: AEs within 90 days of carbon ion radiotherapy start, graded per CTCAE & RTOG acute radiation morbidity criteria. Late toxicities: Radiation-associated tissue injuries new or worsening >90 days after the star radiotherapy initiation.
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