Back to resultsA Study of TC(Docetaxel and Carboplatin) Regimen With or Without Nimotuzumab in Recurrent Metastatic Oral Squamous Cell Carcinoma
Primary Purpose
Oral Squamous Cell Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab
Docetaxel
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Oral Squamous Cell Carcinoma
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.
- Patients with distant metastasis and/or recurrence of 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).
- Unable to perform local treatment (including radiotherapy and 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
Nimotuzumab plus TC Regimen chemotherapy
TC Regimen chemotherapy
Arm Description
Nimotuzumab (200 mg) plus TC Regimen chemotherapy every 3 weeks
TC Regimen chemotherapy every 3 weeks
Outcomes
Primary Outcome Measures
Compare Progression Free Survival (PFS) between Nimotuzumab + TC Regimen chemotherapy and TC Regimen chemotherapy 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.
Secondary Outcome Measures
Compare objective response rate between Nimotuzumab + TC Regimen and TC Regimen chemotherapy.
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 Overall Survival (OS) between Nimotuzumab + TC Regimen chemotherapy and TC Regimen chemotherapy
To compare the efficacy of the combination of Nimotuzumab plus TC Regimen chemotherapy versus TC Regimen chemotherapy in terms of overall survival (OS) in patients with recurrent metastatic oral squamous cell carcinoma. 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 Nimotuzumab + TC Regimen and TC Regimen chemotherapy.
DCR was defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD).
Number of Participants who Experience Treatment Related Adverse Events (AEs).
All Adverse Events and Serious Adverse events will be collected and collated according to grade and frequency. AEs graded using CTCAE (Version 4.0) criteria.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04367909
Brief Title
A Study of TC(Docetaxel and Carboplatin) Regimen With or Without Nimotuzumab in Recurrent Metastatic Oral Squamous Cell Carcinoma
Official Title
A Phase II, Prospective, Single-center, Randomized, Controlled Study of TC(Docetaxel and Carboplatin) Regimen With or Without Nimotuzumab in Recurrent Metastatic Oral Squamous Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 1, 2022 (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 prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of TC Regimenwith or without nimotuzumab in recurrent metastatic oral squamous cell carcinoma. Treatment may continue as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral 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
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nimotuzumab plus TC Regimen chemotherapy
Arm Type
Experimental
Arm Description
Nimotuzumab (200 mg) plus TC Regimen chemotherapy every 3 weeks
Arm Title
TC Regimen chemotherapy
Arm Type
Active Comparator
Arm Description
TC Regimen chemotherapy every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Intervention Description
Nimotuzumab will be administered intravenously at a fixed dose of 200 milligrams (mg) on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel 75 milligrams per square meter (mg/m^2) will be administered intravenously on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin AUC 5 will be administered intravenously on Day 1 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Compare Progression Free Survival (PFS) between Nimotuzumab + TC Regimen chemotherapy and TC Regimen chemotherapy 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
Secondary Outcome Measure Information:
Title
Compare objective response rate between Nimotuzumab + TC Regimen and TC Regimen chemotherapy.
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
Title
Compare Overall Survival (OS) between Nimotuzumab + TC Regimen chemotherapy and TC Regimen chemotherapy
Description
To compare the efficacy of the combination of Nimotuzumab plus TC Regimen chemotherapy versus TC Regimen chemotherapy in terms of overall survival (OS) in patients with recurrent metastatic oral squamous cell carcinoma. 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 Nimotuzumab + TC Regimen and TC Regimen chemotherapy.
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
Title
Number of Participants who Experience Treatment Related Adverse Events (AEs).
Description
All Adverse Events and Serious Adverse events will be collected and collated according to grade and frequency. AEs graded using CTCAE (Version 4.0) criteria.
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.
Patients with distant metastasis and/or recurrence of 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).
Unable to perform local treatment (including radiotherapy and 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
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Wang, Master
Phone
+8615997550081
Ext
+8615997550081
Email
wangyan82033@163.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 TC(Docetaxel and Carboplatin) Regimen With or Without Nimotuzumab in Recurrent Metastatic Oral Squamous Cell Carcinoma
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