NCT04918628

Adjuvant Chemotherapy and Anti-PD-1 Antibody in Patients With Stage IIIC2-IVB Cervical Cancer

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Taizhou Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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）

Detailed description

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).

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Sintilimab	A humanized anti-PD-1 monoclonal antibody

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-06-01
• Completion: 2025-06-01
• First posted: 2021-06-09
• Last updated: 2021-06-09

Locations

1 site across 1 country: China