Trials / Unknown
UnknownNCT04367909
A Study of TC(Docetaxel and Carboplatin) Regimen With or Without Nimotuzumab in Recurrent Metastatic Oral Squamous Cell Carcinoma
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 68 (estimated)
- Sponsor
- Xin-Hua Xu · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-06-21
- Primary completion
- 2021-12-01
- Completion
- 2022-12-01
- First posted
- 2020-04-29
- Last updated
- 2021-11-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04367909. Inclusion in this directory is not an endorsement.