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Iparomlimab and Tuvonralimab With With Cetuximab in Resectable OSCC
Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Summary
This is a single-center, single-arm phase II clinical study designed to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab combined with cetuximab in patients with locally advanced resectable oral squamous cell carcinoma. The treatment regimen for the experimental group is as follows: The recommended dose of epalorestivolimab is 5 mg/kg. Cetuximab is administered at an initial dose of 400 mg/m² followed by 250 mg/m² once weekly, or alternatively cetuximab 500 mg/m² once every 2 weeks, via intravenous infusion. Each treatment cycle lasts 21 days, with 3 cycles administered preoperatively. Patients will undergo surgical resection at 3 weeks ± 7 days after completion of neoadjuvant therapy, followed by concurrent radiotherapy or chemoradiotherapy at 6 weeks ± 2 weeks postoperatively. One clinical tumor imaging assessment will be performed preoperatively per RECIST v1.1 (Appendix 4). In addition, clinically required assessments including vital signs, physical examination, complete blood count, urinalysis, liver and renal function tests, serum electrolytes, thyroid function, electrocardiogram, ECOG performance status, and quality-of-life questionnaires will be completed on Day 1 of each treatment cycle (refer to the study flowchart for specific assessments at each visit). Subjects with hepatitis virus carriage will have viral load monitoring every 2 to 4 treatment cycles. If PD is assessed per RECIST v1.1 but the subject remains clinically stable or the investigator judges that continued treatment may still benefit the subject, reassessment may be performed 4 weeks later using irRECIST. Treatment may be continued if no progressive disease is identified on reassessment.
Official title: A Prospective, Single-arm, Phase II Clinical Study of Iparomlimab and Tuvonralimab With Cetuximab in Patients With Locally Advanced Resectable Oral Squamous Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
26
Start Date
2026-10-16
Completion Date
2029-10-16
Last Updated
2026-10-20
Healthy Volunteers
No
Conditions
Interventions
iparomlimab and tuvonralimab combined with cetuximab
The recommended dose of iparomlimab and tuvonralimab is 5 mg/kg. Cetuximab is administered at an initial dose of 400 mg/m² followed by 250 mg/m² once weekly, or alternatively cetuximab 500 mg/m² once every 2 weeks, via intravenous infusion. Each treatment cycle lasts 21 days, with 3 cycles administered preoperatively. Patients will undergo surgical resection at 3 weeks ± 7 days after completion of neoadjuvant therapy, followed by concurrent radiotherapy or chemoradiotherapy at 6 weeks ± 2 weeks postoperatively.
Locations (1)
the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China