Cervical Cancer Clinical Trial
Official title:
A Safety and Efficacy Study of Neoadjuvant Chemotherapy Combined With CCRT Followed by Adjuvant Chemotherapy and Anti-PD-1 Antibody in Patients With Stage IIIC2-IVB Cervical Cancer
This phase II study is to Evaluate the Safety and Efficacy of Neoadjuvant Chemotherapy Combined With CCRT Followed by Adjuvant Chemotherapy and Anti-PD-1 Antibody in Patients With Stage IIIC2-IVB Cervical Cancer.（ CRTCP）
PRIMARY OBJECTIVES: I. To evaluate the efficacy of adjuvant chemotherapy and anti-PD-1 antibody combined with CCRT in patients with stage IIIC2-IVB cervical cancer. SECONDARY OBJECTIVES: I. To investigate the feasibility of administration of chemotherapy and anti-PD-1 antibody as a adjuvant therapy with chemoradiation (CRT) therapy in patients with stage IIIC2-IVB cervical cancer. II. To determine the nature and degree of toxicity of chemotherapy and anti-PD-1 antibody as a adjuvant therapy with chemoradiation (CRT) therapy in patients with stage IIIC2-IVB cervical cancer. III. To examine the changes in T cell receptor (TCR) clonality, diversity, and frequency in peripheral blood and tissue and correlate this with clinical outcomes, such as the exploratory response assessment on the post-treatment positron emission tomography (PET)-computed tomography (CT) scan and 2-year Progression-Free Survival (PFS). IV. To assess the predictive value of baseline and on-treatment PD-L1 expression in the tissue in each treatment arm for clinical outcomes using post-treatment PET-CT scan and 2-year PFS as the outcome measures. EXPLORATORY OBJECTIVES: I. To explore baseline and on-treatment blood and tissue biomarkers that could predict response to the combination therapy and 2-year PFS. II. To explore the response assessment on the exploratory and the clinical 2-year Progression-Free Survival (PFS). ;
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