Actively Recruiting
Neoadjuvant PD-1 Inhibitor Combined With Cetuximab and Platinum in Resectable Locally Advanced Hypopharyngeal Carcinoma
Led by Eye & ENT Hospital of Fudan University · Updated on 2024-04-30
32
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to evaluate the efficacy and safety of immunotherapy combined with cetuximab and platinum neoadjuvant therapy in patients with resectable locally advanced hypopharyngeal cancer. Participants will receive three cycles of TPC neoadjuvant therapy (toripalimab+ cetuximab + platinum), radical surgery (laryngeal preservation surgery if possible), and sequential (chemo)radiotherapy treatment after surgery. This trial aims to answer the following questions: 1. pCR rate 2. MPR rate, ORR, LPR/DFS/OS rare at 1 and 2 years 3. Safety and quality of life
CONDITIONS
Official Title
Neoadjuvant PD-1 Inhibitor Combined With Cetuximab and Platinum in Resectable Locally Advanced Hypopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed hypopharyngeal squamous cell carcinoma
- Age between 18 and 75 years
- Resectable locally advanced hypopharyngeal cancer with T3-4aN0-3bM0 stage requiring total laryngectomy
- At least one evaluable target lesion according to RECIST 1.1 criteria
- No previous treatment for hypopharyngeal carcinoma
- ECOG performance status 0-1
- Estimated survival of at least 6 months
- Normal organ function
- HBV DNA less than 500 IU/mL (or 2500 copies/mL) and HCV RNA negative
- Signed informed consent
- Willing and able to follow treatment, visit schedules, and research procedures
- Male or non-pregnant female using contraception during treatment
You will not qualify if you...
- History of other cancers in the past five years except certain cured skin, prostate, thyroid, breast, or cervix cancers
- Target lesion previously treated with radiation or surgery except biopsy
- Previous chemotherapy, immunotherapy, or targeted therapy for the primary tumor
- Participation in other clinical trials within four weeks before this trial
- Certain cardiovascular diseases within six months including myocardial infarction, unstable angina, bypass grafting, heart failure, stroke, TIA, or pulmonary embolism
- Uncontrolled hypertension (systolic >140 mmHg or diastolic >90 mmHg)
- Grade I or higher coronary heart disease, arrhythmia, or cardiac insufficiency
- Positive urine protein test (2+ or above) or significant proteinuria
- Severe allergies or active autoimmune diseases that may worsen with immunostimulants
- Use of systemic corticosteroids (>10 mg prednisone or equivalent) or immunosuppressants within two weeks before study drug start
- Diagnosed immunodeficiency, HIV/AIDS, active hepatitis B or C infection, or history of active or previous tuberculosis
- History of psychotropic substance abuse or mental disorders
- Vaccination with live vaccine within four weeks before enrollment
- Pregnant or breastfeeding women, or women of reproductive age not using effective contraception
- Any severe acute or chronic medical or psychiatric condition deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200031
Actively Recruiting
Research Team
L
Lei Tao, PhD
CONTACT
X
Xiaoshen Wang, PhD
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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