Actively Recruiting
Study of Pembrolizumab Combined with Chemotherapy in the First Line Therapy for R/M HNSCC in China
Led by Yuankai Shi · Updated on 2025-01-28
150
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is main evaluate the efficacy and safety of pembrolizumab combined with chemotherapy in the first-line treatment of Chinese patients with recurrent or metastatic head and neck squamous cell carcinoma
CONDITIONS
Official Title
Study of Pembrolizumab Combined with Chemotherapy in the First Line Therapy for R/M HNSCC in China
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign written informed consent before screening
- Age 18 to 75 years old
- ECOG physical status score 0-1
- Histologically or cytologically confirmed head and neck squamous cell carcinoma at oral cavity, oropharynx, hypopharynx, or larynx
- Recurrent and/or metastatic disease without indication for local radical treatment
- At least one measurable lesion according to RECIST 1.1; lesions previously treated with radiotherapy must show progression at least 3 months after radiotherapy
- Availability of sufficient tumor tissue for PD-L1 testing
- Expected survival longer than 3 months
- Adequate main organ function including blood counts, liver, kidney, coagulation, and heart function as specified
- Women and men agree to use effective contraception during the study and for 6 months after
- Negative pregnancy test for women before enrollment and not breastfeeding
You will not qualify if you...
- Suitable and willing for local treatment
- Prior systemic chemotherapy within 6 months except as part of multimodal treatment for locally advanced disease
- Disease progression within 6 months after completing multimodal treatment for locally advanced disease
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibodies, or other related immunotherapies
- Other malignancies within 5 years except certain cured cancers
- Cetuximab treatment within 6 months before study
- Grade 2 or higher peripheral neuropathy
- Active central nervous system metastases or cancerous meningitis not stable or symptomatic
- Unresolved acute toxic effects of prior treatments above grade 1 except hair loss
- Severe allergic reactions to study drugs
- Prior anti-tumor treatments except palliative radiotherapy for pain
- Use of Chinese herbal or patent medicines with anti-tumor effects within 1 week before study
- Major surgery within 4 weeks before study or planned during study
- Use of immunosuppressive drugs within 2 weeks before or during study except specific allowed steroids
- Active or history of autoimmune diseases likely to relapse except stable type I diabetes, autoimmune hypothyroidism, or mild skin diseases
- History or suspicion of interstitial lung disease or non-infectious pneumonia except asymptomatic
- HIV infection or immunodeficiency diseases, organ or stem cell transplantation history
- Active hepatitis B or C infection above specified viral load thresholds
- Active infection requiring systemic treatment within 2 weeks before study
- Live virus vaccination within 4 weeks before study except inactivated flu vaccine
- Symptomatic serous effusions requiring intervention or less than 4 weeks stable
- Serious medical conditions such as severe heart disease, recent myocardial infarction, poorly controlled diabetes or hypertension
- Medical or psychiatric conditions or laboratory abnormalities interfering with study
- Concurrent participation in other drug or device studies within 4 weeks
- Known addiction to alcohol or drugs
- Other conditions affecting compliance or assessment as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Cancer Center/Cancer Hospitial,Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
Y
Yuankai Shi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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