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

NCT04367909 | Unknown Phase 2

• 1 other identifier: CTGU004
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  approximately 24 months

Secondary Outcomes (4)

• Compare objective response rate between Nimotuzumab + TC Regimen and TC Regimen chemotherapy.

  approximately 24 months

• Compare Overall Survival (OS) between Nimotuzumab + TC Regimen chemotherapy and TC Regimen chemotherapy

  approximately 24 months

• Compare Disease Control Rate (DCR) between Nimotuzumab + TC Regimen and TC Regimen chemotherapy.

  approximately 24 months

• Number of Participants who Experience Treatment Related Adverse Events (AEs).

  approximately 24 months

Study Arms (2)

Nimotuzumab plus TC Regimen chemotherapy

EXPERIMENTAL

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

Drug: Nimotuzumab; Drug: Docetaxel; Drug: Carboplatin

TC Regimen chemotherapy

ACTIVE COMPARATOR

TC Regimen chemotherapy every 3 weeks

Drug: Docetaxel; Drug: Carboplatin

Interventions

Nimotuzumab DRUG

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

Nimotuzumab plus TC Regimen chemotherapy

Docetaxel DRUG

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

Nimotuzumab plus TC Regimen chemotherapy; TC Regimen chemotherapy

Carboplatin DRUG

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

Nimotuzumab plus TC Regimen chemotherapy; TC Regimen chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xin-Hua Xu: lead

Study Sites (1)

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

Yichang, Hubei, 443003, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

nimotuzumab; Docetaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Central Study Contacts

Xinhua Xu, Master

CONTACT

+8613986747496; 2732774352@qq.com

Yan Wang, Master

CONTACT

+8615997550081; wangyan82033@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 29, 2020
• Study Start: June 21, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: November 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)