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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

Primary Purpose

Oral Cavity Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sintilimab
Radiotherapy
Sponsored by
Xin-Hua Xu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Cavity Squamous Cell Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 2. Eastern Collaborative Oncology Group Performance status (ECOG PS) 0 ,1 or 2. 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 1.1. 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]. Has a life expectancy of at ≥3 months. Exclusion Criteria: ECOG PS >2. 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.

Sites / Locations

  • Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sintilimab+Cisplatin+Radiotherapy

Cisplatin+Radiotherapy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Compare Overall Survival (OS) between Chemoradiotherapy Based of Cisplatin + Sintilimab Regimen and Chemoradiotherapy Based of Cisplatin Regimen.
Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.
Compare Disease Control Rate (DCR) between Chemoradiotherapy Based of Cisplatin + Sintilimab Regimen and Chemoradiotherapy Based of Cisplatin Regimen using RECIST 1.1.
DCR was defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD).

Full Information

First Posted
February 18, 2023
Last Updated
February 18, 2023
Sponsor
Xin-Hua Xu
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1. Study Identification

Unique Protocol Identification Number
NCT05749042
Brief 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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
January 18, 2025 (Anticipated)
Study Completion Date
January 18, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xin-Hua Xu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cavity Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sintilimab+Cisplatin+Radiotherapy
Arm Type
Experimental
Arm Title
Cisplatin+Radiotherapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Other Intervention Name(s)
Cisplatin, Radiotherapy
Intervention Description
Concurrent Chemoradiotherapy Based of Cisplatin Plus Sintilimab.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Other Intervention Name(s)
Cisplatin
Intervention Description
Concurrent Chemoradiotherapy Based of Cisplatin
Primary Outcome Measure Information:
Title
Compare Progression Free Survival (PFS) between Chemoradiotherapy Based of Cisplatin + Sintilimab Regimen and Chemoradiotherapy Based of Cisplatin Regimen using RECIST 1.1.
Description
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.
Time Frame
approximately 24 months
Title
Compare objective response rate(ORR) between Chemoradiotherapy Based of Cisplatin + Sintilimab Regimen and Chemoradiotherapy Based of Cisplatin Regimen using RECIST 1.1.
Description
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.
Time Frame
approximately 24 months
Secondary Outcome Measure Information:
Title
Compare Overall Survival (OS) between Chemoradiotherapy Based of Cisplatin + Sintilimab Regimen and Chemoradiotherapy Based of Cisplatin Regimen.
Description
Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.
Time Frame
approximately 24 months
Title
Compare Disease Control Rate (DCR) between Chemoradiotherapy Based of Cisplatin + Sintilimab Regimen and Chemoradiotherapy Based of Cisplatin Regimen using RECIST 1.1.
Description
DCR was defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD).
Time Frame
approximately 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 2. Eastern Collaborative Oncology Group Performance status (ECOG PS) 0 ,1 or 2. 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 1.1. 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]. Has a life expectancy of at ≥3 months. Exclusion Criteria: ECOG PS >2. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinhua Xu, Master
Phone
+8613986747496
Ext
+8613986747496
Email
2732774352@qq.com
Facility Information:
Facility Name
Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University
City
Yichang
State/Province
Hubei
ZIP/Postal Code
443003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinhua Xu
Phone
+8613986747496
Ext
+8613986747496
Email
2732774352@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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