Concurrent Chemoradiotherapy Based of Cisplatin With or Without Sintilimab as First-line Therapy for Patients With Advanced Oral Cavity Squamous Cell Carcinoma :a Phase 2,Prospective, Open-label,Unicentral,Randomised Controlled Trial

Xin-Hua Xu1 site in 1 country70 target enrollmentJanuary 18, 2023

ConditionsOral Cavity Squamous Cell Carcinoma

InterventionsSintilimab Radiotherapy

DrugsSintilimab

Overview

Phase: Phase 2
Intervention: Sintilimab
Conditions: Oral Cavity Squamous Cell Carcinoma
Sponsor: Xin-Hua Xu
Enrollment: 70
Locations: 1
Primary Endpoint: Compare objective response rate(ORR) between Chemoradiotherapy Based of Cisplatin + Sintilimab Regimen and Chemoradiotherapy Based of Cisplatin Regimen using RECIST 1.1.
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to evaluate the efficacy and safety of concurrent chemoradiotherapy based of cisplatin with sintilimab as first-line therapy for patients with advanced oral cavity squamous cell carcinoma.

Registry

clinicaltrials.gov

Start Date

January 18, 2023

End Date

January 18, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Xin-Hua Xu

Responsible Party

Sponsor Investigator

Principal Investigator

Xin-Hua Xu

professor

China Three Gorges University, Yichang, China

Eligibility Criteria

Inclusion Criteria

•Volunteer to participate in clinical research; fully understand and know the research and sign informed consent.
•Age ≥18 years, and ≤75years , either sex.
•Eastern Collaborative Oncology Group Performance status (ECOG PS) 0 ,1 or
•Eastern Collaborative Oncology Group Performance status (ECOG PS) 0 ,1 or
•Patients with oral squamous cell carcinoma (including gingival cancer, tongue cancer, lip cancer, buccal cancer, oral cancer, etc) diagnosed by histopathology (according to the 8th edition of AJCC).
•Initial diagnosis patients unable to perform surgery.
•Have at least one measurable lesion as defined by RECIST 1.
•Normal hepatic function: total bilirubin≤1.5×normal upper limit (ULN); Alanine aminotransferase and Aspartate aminotransferase levels ≤2.5×ULN or ≤5×ULN if liver metastasis is present.
•Normal renal function ：Creatinine ≤1.5×ULN or calculated creatinine clearance ≥45 mL/min (using Cockcroft/Gault formula to calculate ).
•Normal hematological function：absolute neutrophil count ≥1.5×109/L, platelet count ≥70×109/L, hemoglobin≥80g/L \[no blood transfusion or erythropoietin (EPO) within 7 days\] Dependency\].

Exclusion Criteria

•Patients who received radiotherapy, chemotherapy, monoclonal antibody and oral EGFR-TKI therapy within three months.
•Patients who are receiving any other investigational agents within 30 days prior to entering the study.
•The tumor has metastasized to the brain and / or pia mater.
•History of other malignancies (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignancies that have been cured for more than 5 years).
•Accompanied by other serious diseases, including but not limited to:
•Uncontrollable congestive heart failure (NYHA grade Ⅲ or Ⅳ), unstable angina, poorly controlled arrhythmia, uncontrolled moderate or above hypertension (SBP \> 160mmhg or DBP \> 100mmhg) ; Severe active infection; Uncontrollable diabetes (refers to the high fluctuation of blood glucose, the impact on patients' life and the frequent occurrence of hypotension despite the standard insulin treatment and frequent blood glucose monitoring) ; Mental illness affecting informed consent and / or program compliance.
•Those who are allergic to the drug or its components used in the program.
•Pregnancy (confirmed by hCG test in blood or urine) or lactating women, or childbearing age subjects are unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last trial treatment.
•Those who are not considered suitable for the study by the researchers.
•Unwilling to participate in this study or unable to sign informed consent.

Arms & Interventions

Sintilimab+Cisplatin+Radiotherapy

Intervention: Sintilimab

Cisplatin+Radiotherapy

Intervention: Radiotherapy

Outcomes

Primary Outcomes

Compare objective response rate(ORR) between Chemoradiotherapy Based of Cisplatin + Sintilimab Regimen and Chemoradiotherapy Based of Cisplatin Regimen using RECIST 1.1.

Time Frame: approximately 24 months

ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria.

Compare Progression Free Survival (PFS) between Chemoradiotherapy Based of Cisplatin + Sintilimab Regimen and Chemoradiotherapy Based of Cisplatin Regimen using RECIST 1.1.

Time Frame: approximately 24 months

PFS was defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1.

Secondary Outcomes

Compare Overall Survival (OS) between Chemoradiotherapy Based of Cisplatin + Sintilimab Regimen and Chemoradiotherapy Based of Cisplatin Regimen.(approximately 24 months)
Compare Disease Control Rate (DCR) between Chemoradiotherapy Based of Cisplatin + Sintilimab Regimen and Chemoradiotherapy Based of Cisplatin Regimen using RECIST 1.1.(approximately 24 months)