Actively Recruiting
A Phase II Study of Neoadjuvant Immunotherapy in Combination With Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
Led by Lei Liu · Updated on 2024-12-02
90
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Randomized, Phase II Study of ivonescimab or cadonilimab or penpulimab in Combination With Cisplatin and Nab-paclitaxel in Patients With locally advanced head and neck squamous cell carcinoma (HNSCC) eligible for resection. This proposed study will evaluate the efficacy and safety of preoperative administration of ivonescimab or cadonilimab or penpulimab combined with chemotherapy in HNSCC who are eligible for resection.
CONDITIONS
Official Title
A Phase II Study of Neoadjuvant Immunotherapy in Combination With Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years
- Histologically or cytologically confirmed head and neck squamous cell carcinoma
- Resectable locally advanced head and neck squamous cell carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- No prior treatment for the cancer
- Intention to undergo curative treatment
- Normal organ function suitable for immunotherapy combined with chemotherapy and surgery, including adequate blood counts, liver, kidney, heart, and coagulation function
- Well-controlled blood pressure (systolic 150 mmHg and diastolic 90 mmHg) with or without medication
- Patients with hepatitis B virus infection must receive antiviral therapy before and during the study, and for 6 months after treatment
- Women of childbearing potential (15-49 years old) must have a negative pregnancy test and agree to use effective contraception during the study and for 3 months after
- Voluntary participation, informed consent, good compliance, and cooperation with follow-up
You will not qualify if you...
- Previous anti-tumor treatment
- Allergic constitution or congenital immune deficiencies
- History of organ transplantation
- History of severe bleeding or coagulation disorders, recent significant bleeding, or recent prolonged anticoagulation treatment
- Arteriovenous thrombotic events within 6 months before treatment
- Active or history of autoimmune or inflammatory diseases, except certain stable or inactive conditions
- Active infections including tuberculosis or HIV
- Uncontrolled complications such as infections, heart failure, diabetes, hypertension, angina, arrhythmias, lung disease, severe gastrointestinal disease, or psychiatric/social issues affecting compliance
- Pregnant or breastfeeding women
- Non-compliance with contraception requirements
- Participation in other clinical studies simultaneously
- Critically ill patients unable to complete the study
- History of other primary malignant tumors except certain treated and inactive cancers
- History or current psychiatric illness or conditions preventing normal communication
- Other malignant neoplastic diseases
- Any condition considered unsuitable by the researcher affecting participation or completion of the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital
Chengdu, Sichuan, China
Actively Recruiting
Research Team
L
Lei Liu, M.D.
CONTACT
Y
Yuanyuan Zeng, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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