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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
A humanized anti-PD-1 monoclonal antibody
Youyou Xie
Taizhou, Zhejiang, China
RECRUITINGNumber of participants with Grade 3 and Grade 4 Treatment-related adverse events (TRAEs)
To assess the safety and tolerability profile of Sintilimab as defined by Grade 3 and Grade 4 TRAEs within 6 months from the initiation of durvalumab Sintilimab treatment
Time frame: From screening till final visit (upto a maximum of 24 months)
Median Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the Investigator
To assess the efficacy of Sintilimab treatment in terms of PFS. PFS will be calculated using Kaplan-Meier product limit methods.
Time frame: From the first date of treatment until the date of objective disease progression or death (up to maximum 24 months)
PFS at 24 months (PFS24)
To assess the efficacy of Sintilimab treatment in terms of PFS. PFS will be calculated using Kaplan-Meier product limit methods.
Time frame: From the first date of treatment until the date of objective disease progression or death (up to maximum 24 months)
Median overall survival (OS)
To assess the efficacy of Sintilimab treatment in terms of OS. OS will be calculated using Kaplan-Meier product limit methods.
Time frame: From the first date of treatment until death due to any cause (up to maximum 24 months)
OS at 24 months (OS24)
To assess the efficacy of Sintilimab treatment in terms of OS. OS will be calculated using Kaplan-Meier product limit methods.
Time frame: Time Frame: From the first date of treatment until death due to any cause (up to maximum 24 months)
Number of participants with immunological colitis
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
To assess the safety and tolerability profile of Sintilimab treatment in terms of the number of participants with abnormal immunological colitis. Immunological colitis will be collected before, during, and after Sintilimab infusion. Fecal occult blood test to assess gastrointestinal bleeding, gastrointestinal angiography to assess gastrointestinal perforation.
Time frame: From screening till final visit (up to a maximum of 24 months)
Number of participants with immunological rash
To assess the safety and tolerability profile of Sintilimab treatment in terms of the number of participants with abnormal immunological rash. Immunological rash will be collected before, during, and after Sintilimab infusion.
Time frame: From screening till final visit (up to a maximum of 24 months)
Number of participants with abnormal blood pressure (BP)
To assess the safety and tolerability profile of Sintilimab treatment in terms of the number of participants with abnormal BP. BP will be collected before, during, and after IP infusion.
Time frame: From screening till final visit (up to a maximum of 24 months)