Trials / Unknown
UnknownNCT04405154
A Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced Head and Neck Cancer
A Phase II Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced, Unresectable Head and Neck Squamous Cell Carcinoma
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- Sponsor
- West China Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this study is to determine the efficacy and safety of camrelizumab given concomitantly with chemoradiation in participants with unresectable, locally advanced head and neck squamous cell carcinoma (LA-HNSCC). All participants will receive camrelizumab in addition to chemoradiation, the standard treatment for LA-HNSCC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Camrelizumab | Administered as an intravenous (IV) infusion every 2 weeks (Q2W): 14 days prior to radiation, then Day 1 of radiation and then every 14 days for total 8 doses. |
| DRUG | Cisplatin | 75-100 mg/m\^2 administered as an IV infusion Q3W, for a total of 3 doses, at the same time as radiation: Day 1, Day 22, Day 43 of radiation. |
| RADIATION | IMRT or VMAT | 66-70 Gy given in 33-35 fractions over 6-7 weeks. |
Timeline
- Start date
- 2020-06-01
- Primary completion
- 2023-05-31
- Completion
- 2025-05-31
- First posted
- 2020-05-28
- Last updated
- 2020-05-28
Source: ClinicalTrials.gov record NCT04405154. Inclusion in this directory is not an endorsement.