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Trial Title:
A Study of Concurrent Chemoradiotherapy Based of Cisplatin With or Without Sintilimab as First-line Therapy for Patients With Advanced Oral Cavity Squamous Cell Carcinoma
NCT ID:
NCT05749042
Condition:
Oral Cavity Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Cisplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
Concurrent Chemoradiotherapy Based of Cisplatin Plus Sintilimab.
Arm group label:
Sintilimab+Cisplatin+Radiotherapy
Other name:
Cisplatin
Other name:
Radiotherapy
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
Concurrent Chemoradiotherapy Based of Cisplatin
Arm group label:
Cisplatin+Radiotherapy
Other name:
Cisplatin
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Volunteer to participate in clinical research; fully understand and know the
research and sign informed consent.
2. Age ≥18 years, and ≤75years , either sex.
3. Eastern Collaborative Oncology Group Performance status (ECOG PS) 0 ,1 or 2.
4. Eastern Collaborative Oncology Group Performance status (ECOG PS) 0 ,1 or 2.
5. 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).
6. Initial diagnosis patients unable to perform surgery.
7. Have at least one measurable lesion as defined by RECIST 1.1.
8. 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.
9. Normal renal function ：Creatinine ≤1.5×ULN or calculated creatinine clearance ≥45
mL/min (using Cockcroft/Gault formula to calculate ).
10. 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].
11. Has a life expectancy of at ≥3 months.
Exclusion Criteria:
1. ECOG PS >2.
2. Patients who received radiotherapy, chemotherapy, monoclonal antibody and oral
EGFR-TKI therapy within three months.
3. Patients who are receiving any other investigational agents within 30 days prior to
entering the study.
4. The tumor has metastasized to the brain and / or pia mater.
5. 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).
6. 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.
7. Those who are allergic to the drug or its components used in the program.
8. 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.
9. Those who are not considered suitable for the study by the researchers.
10. Unwilling to participate in this study or unable to sign informed consent.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University
Address:
City:
Yichang
Zip:
443003
Country:
China
Status:
Recruiting
Contact:
Last name:
Xinhua Xu
Phone:
+8613986747496
Phone ext:
+8613986747496
Email:
2732774352@qq.com
Start date:
January 18, 2023
Completion date:
January 18, 2025
Lead sponsor:
Agency:
Xin-Hua Xu
Agency class:
Other
Source:
China Three Gorges University, Yichang, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05749042
