Actively Recruiting
Evaluating the Efficacy and Safety of Pembrolizumab Plus Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced (LA) HNSCC
Led by Beijing Tongren Hospital · Updated on 2023-10-30
272
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, open-label, multi-center phase III study; patients with untreated stage IIIA to stage IVB head and neck squamous cell carcinoma (including oral cavity cancer, oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer) who meet the inclusion criteria are randomized 1:1 and given pembrolizumab 200 mg d1+ chemotherapy for 2 cycles (experimental group), 2 cycles of chemotherapy (control group), and then stratified according to the patient's condition. If the imaging evaluation after neoadjuvant treatment is (complete response, CR), adjuvant radiotherapy will be given; if the imaging evaluation is (partial response, PR) or (stable disease, SD), surgery (within 2 weeks) will be performed, followed by standard treatment. The main research hypothesis of this study: pembrolizumab combined with standard chemotherapy can significantly improve the rate of pathological complete response (pCR) compared with standard chemotherapy.
CONDITIONS
Official Title
Evaluating the Efficacy and Safety of Pembrolizumab Plus Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced (LA) HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with stage IIIA-IVB head and neck squamous cell carcinoma confirmed by histology and/or cytology
- Have not received immunotherapy in the past
- Able to safely receive pembrolizumab combined with chemotherapy or neoadjuvant chemotherapy
- Age 18 years or older
- ECOG performance status 0-2
- Measurable disease as defined by RECIST v1.1
- Normal organ function
- Female and male participants of reproductive potential must agree to use appropriate contraception during the study and for 180 days after last treatment
- Male participants must not donate sperm during the study and for 180 days after last treatment
You will not qualify if you...
- Presence of distant metastasis
- Positive urine pregnancy test within 72 hours before study start or within 24 hours after starting radiation therapy
- Received a live vaccine within 30 days before enrollment
- Diagnosed with immunodeficiency or receiving systemic steroid or other immunosuppressive treatment within 7 days before enrollment
- Have central nervous system metastases or cancerous meningitis
- Have had surgery before starting the study or have not recovered from surgery-related toxicity or complications
- Previous allogeneic tissue or solid organ transplant
- Severe hypersensitivity reaction (grade 3 or higher) to pembrolizumab, radiotherapy, platinum, paclitaxel, 5-FU, or their analogs
- Active autoimmune disease requiring systemic therapy in the past 2 years
- History of non-infectious pneumonia requiring steroid treatment
- History of HIV infection
- History of hepatitis B or positive for hepatitis B surface antigen or active hepatitis C
- Any medical history, treatment, or lab abnormalities that could affect study results or participant safety
- Known history of mental illness or substance abuse disorder
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tongren Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
Z
Zhigang Huang
CONTACT
Y
Yang Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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