Actively Recruiting
Penpulimab in Combination With Cetuximab as First-line Treatment in R/M SCCHN
Led by Eye & ENT Hospital of Fudan University · Updated on 2023-10-18
48
Participants Needed
2
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a multicenter, prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of Penpulimab injection combined with cetuximab in the first-line treatment of recurrent/metastatic squamous cell carcinoma of the head and neck.
CONDITIONS
Official Title
Penpulimab in Combination With Cetuximab as First-line Treatment in R/M SCCHN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx)
- Recurrent or metastatic disease not suitable for local treatment such as surgery or radiotherapy
- At least one measurable tumor lesion according to RECIST 1.1 criteria
- Tumor expresses PD-L1 with a comprehensive positive score (CPS) of 1 or higher
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of at least 3 months
- Normal major organ function meeting specified blood, liver, kidney, coagulation, and heart function criteria
- Women of childbearing potential must have a negative pregnancy test within 14 days before enrollment and agree to use reliable contraception; males must use reliable contraception from treatment start to 6 months after last dose
- Voluntary participation with informed consent and ability to comply with study procedures
You will not qualify if you...
- Previous systemic chemotherapy for recurrent/metastatic disease (except chemotherapy as part of multimodal treatment for locally advanced disease)
- Prior immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibodies, or similar agents
- Previous use of anti-EGFR drugs such as cetuximab, nimotuzumab, gefitinib, or afatinib
- Pregnant, lactating, or planning pregnancy during the study
- Participation in another investigational drug or device trial within 4 weeks before randomization
- Uncontrolled or symptomatic active central nervous system metastases
- Active autoimmune diseases or history of certain autoimmune conditions (exceptions apply)
- Use of systemic immunosuppressive drugs within 2 weeks before treatment start, with some exceptions
- Significant cardiovascular disease or left ventricular ejection fraction under 50%
- Active infections requiring systemic treatment or unexplained fever above 38.5°C
- Interstitial lung disease, uncontrolled systemic diseases including diabetes or hypertension beyond specified limits
- Uncontrolled pleural, pericardial effusion, or ascites needing repeated drainage
- History of other malignancies within 5 years except certain cured or localized cancers
- Positive hepatitis B or C viral markers with active infection
- Receipt of live vaccines within 4 weeks before enrollment
- Other serious concomitant diseases that could affect safety or study completion as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Department of radiotherapy,The First Bethune Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
2
Department of Radiotherapy, Eye & ENT Hospital of Fudan University
Shanghai, China
Actively Recruiting
Research Team
X
Xiaoshen Wang
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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