Actively Recruiting
Dalpicilib Plus Cetuximab Compared With Cetuximab Alone in HPV-negative, Anti-PD-1-resistant R/M HNSCC
Led by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Updated on 2025-07-18
98
Participants Needed
1
Research Sites
297 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single center, randomized controlled, prospective phase II clinical trial to evaluate the efficacy and safety of cetuximab combined with dalpicilib compared to cetuximab monotherapy in patients with HPV-negative, anti-PD-1-resistant recurrent or metastatic head and neck squamous cell carcinoma. The participants would receive cetuximab combined with dalpicilib or cetuximab monotherapy until termination criteria are met.
CONDITIONS
Official Title
Dalpicilib Plus Cetuximab Compared With Cetuximab Alone in HPV-negative, Anti-PD-1-resistant R/M HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years, both sexes.
- Histologically confirmed recurrent or metastatic or locally advanced inoperable head and neck squamous cell carcinoma with measurable lesions.
- Received at least 1 cycle of prior PD-1 immunotherapy with progression or no benefit, completed at least 4 weeks before study drug.
- HPV viral testing negative by IHC method.
- Availability of tumor tissue for PD-L1 and CDK4-related gene detection.
- ECOG score 0 or 1.
- Expected survival of at least 12 weeks.
- Normal major organ function within 2 weeks before treatment, including bone marrow, liver, renal, urine protein, blood glucose, pulmonary, and cardiac function as specified.
You will not qualify if you...
- Previous treatment with cetuximab or other anti-EGFR monoclonal antibodies or small molecule tyrosine kinase inhibitors.
- Currently receiving antineoplastic therapy.
- Participation in another drug or therapy clinical trial within 4 weeks before study drug.
- Use of hematopoietic stimulating factors within 1 week before study drug.
- Positive HIV antibody or syphilis spirochete antibody test.
- Active hepatitis B or C infection.
- Known hypersensitivity to EGFR monoclonal antibody drugs.
- Massive pleural or ascites fluid requiring management.
- Active lung disease or history of active tuberculosis.
- Uncontrollable clinical problems including severe infection, poorly controlled diabetes, serious cardiac disease, thrombosis, or recent cardiovascular events.
- Previous stem cell or organ transplantation.
- History of psychotropic substance abuse or psychiatric disorders.
- Other serious medical conditions or lab abnormalities increasing risk or interfering with study.
- Poor compliance or unsuitable conditions as judged by investigator.
- History of other malignancies within five years.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
Research Team
G
Guoxin Ren
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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