Actively Recruiting
Iparomlimab and Tuvonralimab Plus Hypofractionated Radiotherapy and Chemotherapy for HAHNSCC
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-03-03
27
Participants Needed
1
Research Sites
271 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Head and neck squamous cell carcinoma (HNSCC) is often diagnosed at a locally advanced stage, where cisplatin-based chemoradiotherapy is standard but still results in high recurrence rates. Immunotherapy is promising for HNSCC due to its high mutational burden, and adding PD-1 inhibitors to induction chemotherapy has improved responses without added toxicity. Radiotherapy can further stimulate antitumor immunity. Iparomlimab and Tuvonralimab, a dual anti-PD-1/CTLA-4 antibody, has shown strong activity across several solid tumors, and early studies suggest synergy with hypofractionated radiotherapy. However, evidence in locally advanced HNSCC is lacking. The investigators therefore propose a multicenter, single-arm phase II trial to assess the efficacy and safety of combining Iparomlimab and Tuvonralimab injection with chemoradiotherapy in locoregionally advanced HNSCC.
CONDITIONS
Official Title
Iparomlimab and Tuvonralimab Plus Hypofractionated Radiotherapy and Chemotherapy for HAHNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and agrees to study visits
- Male or female aged 18 to 75 years
- ECOG performance status score of 0 or 1
- Histologically or cytologically confirmed stage III-IVB head and neck squamous cell carcinoma
- No prior systemic therapy for head and neck squamous cell carcinoma
- At least one measurable target lesion per RECIST v1.1
- Life expectancy of at least 12 weeks
- Adequate bone marrow and organ function per specified laboratory criteria
- Infertile or agrees to use highly effective contraception during the study until 180 days after last study drug dose
You will not qualify if you...
- Allergy to any component of anti-PD-1/CTLA-4 antibodies or cisplatin
- History or presence of other malignancies except certain cured cancers without recurrence for over 5 years
- Uncontrolled cardiac symptoms or diseases including NYHA class II or higher heart failure, unstable angina, recent myocardial infarction, or significant arrhythmias
- Prior treatment with immune checkpoint inhibitors or recent use of investigational drugs
- Current participation in another clinical trial unless observational
- Need for systemic corticosteroids or immunosuppressive drugs within 2 weeks before study drug
- Recent antitumor or live vaccine within 4 weeks before study drug
- Major surgery or severe trauma within 4 weeks before study drug
- Failure to recover from prior antitumor therapy except certain conditions
- Severe infection within 4 weeks before study drug
- Active or history of autoimmune disease with some exceptions
- History of immunodeficiency including HIV or prior transplant
- History of interstitial lung disease or noninfectious pneumonitis
- Active or recent tuberculosis
- Active hepatitis B or C infection
- History of substance or alcohol abuse
- Pregnant or breastfeeding
- Other factors making study participation unsafe or unreliable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital Of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
H
Haiyan Chen, Doctor
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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