A Study of TC(Docetaxel and Carboplatin) Regimen With or Without Nimotuzumab in Recurrent Metastatic Oral Squamous Cell Carcinoma

Sponsor

Xin-Hua Xu (Other)

Overall Status

Recruiting

CT.gov ID

NCT04367909

Collaborator

(none)

Enrollment

Location

Arms

29.3

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Squamous Cell Carcinoma	Drug: Nimotuzumab Drug: Docetaxel Drug: Carboplatin	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 21, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nimotuzumab plus TC Regimen chemotherapy Nimotuzumab (200 mg) plus TC Regimen chemotherapy every 3 weeks	Drug: Nimotuzumab Nimotuzumab will be administered intravenously at a fixed dose of 200 milligrams (mg) on Day 1 of each 21-day cycle. Drug: Docetaxel Docetaxel 75 milligrams per square meter (mg/m^2) will be administered intravenously on Day 1 of each 21-day cycle. Drug: Carboplatin Carboplatin AUC 5 will be administered intravenously on Day 1 of each 21-day cycle.
Active Comparator: TC Regimen chemotherapy TC Regimen chemotherapy every 3 weeks	Drug: Docetaxel Docetaxel 75 milligrams per square meter (mg/m^2) will be administered intravenously on Day 1 of each 21-day cycle. Drug: Carboplatin Carboplatin AUC 5 will be administered intravenously on Day 1 of each 21-day cycle.

Arm

Intervention/Treatment

Experimental: Nimotuzumab plus TC Regimen chemotherapy

Nimotuzumab (200 mg) plus TC Regimen chemotherapy every 3 weeks

Drug: Nimotuzumab

Nimotuzumab will be administered intravenously at a fixed dose of 200 milligrams (mg) on Day 1 of each 21-day cycle.

Drug: Docetaxel

Docetaxel 75 milligrams per square meter (mg/m^2) will be administered intravenously on Day 1 of each 21-day cycle.

Drug: Carboplatin

Carboplatin AUC 5 will be administered intravenously on Day 1 of each 21-day cycle.

Active Comparator: TC Regimen chemotherapy

TC Regimen chemotherapy every 3 weeks

Drug: Docetaxel

Docetaxel 75 milligrams per square meter (mg/m^2) will be administered intravenously on Day 1 of each 21-day cycle.

Drug: Carboplatin

Carboplatin AUC 5 will be administered intravenously on Day 1 of each 21-day cycle.

Outcome Measures

Primary Outcome Measures

Compare Progression Free Survival (PFS) between Nimotuzumab + TC Regimen chemotherapy and TC Regimen chemotherapy using RECIST 1.1. [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 Outcome Measures

Compare objective response rate between Nimotuzumab + TC Regimen and TC Regimen chemotherapy. [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 Overall Survival (OS) between Nimotuzumab + TC Regimen chemotherapy and TC Regimen chemotherapy [approximately 24 months]
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. [approximately 24 months]
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). [approximately 24 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University	Yichang	Hubei	China	443003