A Study of TC(Docetaxel and Carboplatin) Regimen With or Without Nimotuzumab in Recurrent Metastatic Oral Squamous Cell Carcinoma
NCT ID: NCT04367909
Last Updated: 2021-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
68 participants
INTERVENTIONAL
2020-06-21
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nimotuzumab plus TC Regimen chemotherapy
Nimotuzumab (200 mg) plus TC Regimen chemotherapy every 3 weeks
Nimotuzumab
Nimotuzumab will be administered intravenously at a fixed dose of 200 milligrams (mg) on Day 1 of each 21-day cycle.
Docetaxel
Docetaxel 75 milligrams per square meter (mg/m\^2) will be administered intravenously on Day 1 of each 21-day cycle.
Carboplatin
Carboplatin AUC 5 will be administered intravenously on Day 1 of each 21-day cycle.
TC Regimen chemotherapy
TC Regimen chemotherapy every 3 weeks
Docetaxel
Docetaxel 75 milligrams per square meter (mg/m\^2) will be administered intravenously on Day 1 of each 21-day cycle.
Carboplatin
Carboplatin AUC 5 will be administered intravenously on Day 1 of each 21-day cycle.
Interventions
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Nimotuzumab
Nimotuzumab will be administered intravenously at a fixed dose of 200 milligrams (mg) on Day 1 of each 21-day cycle.
Docetaxel
Docetaxel 75 milligrams per square meter (mg/m\^2) will be administered intravenously on Day 1 of each 21-day cycle.
Carboplatin
Carboplatin AUC 5 will be administered intravenously on Day 1 of each 21-day cycle.
Eligibility Criteria
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Inclusion Criteria
2. Age ≥18 years, and ≤75years , either sex.
3. Eastern Collaborative Oncology Group Performance status (ECOG PS) 0 ,1 or 2.
4. 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).
5. Unable to perform local treatment (including radiotherapy and surgery).
6. Have at least one measurable lesion as defined by RECIST 1.1.
7. 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.
8. Normal renal function ：Creatinine ≤1.5×ULN or calculated creatinine clearance ≥45 mL/min (using Cockcroft/Gault formula to calculate ).
9. 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\].
10. Has a life expectancy of at ≥3 months.
Exclusion Criteria
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.
18 Years
75 Years
ALL
No
Sponsors
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Xin-Hua Xu
OTHER
Responsible Party
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Xin-Hua Xu
professor
Locations
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Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University
Yichang, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Xinhua Xu
Role: primary
Other Identifiers
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CTGU004
Identifier Type: -
Identifier Source: org_study_id