Ivonescimab Combined With Chemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma
- Sponsor
- Sun Yat-sen University
- Study ID
- NCT07064902
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Nasopharyngeal Carcinoma (NPC)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Ivonescimab(AK112,a PD-1/VEGF bispecific antibody) — DRUGIvonescimab (AK112) is a novel PD-1/VEGF bispecific antibody designed to simultaneously block PD-1-mediated immune evasion and inhibit VEGF-driven angiogenesis. In this study, ivonescimab is administered intravenously at a dose of 10 mg/kg every 3 weeks, starting on Day 1 of induction chemotherapy (3 cycles), followed by concurrent chemoradiotherapy (no ivonescimab), and then continued as adjuvant monotherapy for 9 additional cycles.
Study Details
This trial aims to study the role of Ivonescimab combined with chemoradiotherapy in high-Risk locoregionally advanced nasopharyngeal carcinoma.
Key Dates
- Start date
- Aug 1, 2025
- Status verified
- Jul 2025
- Primary completion
- Aug 31, 2026
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 48 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Ivonescimab armParticipants in this arm will receive induction chemotherapy with gemcitabine (1000 mg/m² on Days 1 and 8, Q3W × 3 cycles) and cisplatin (80 mg/m² on Day 1, Q3W × 3 cycles), combined with ivonescimab (10 mg/kg on Day 1, Q3W × 3 cycles). This will be followed by concurrent chemoradiotherapy (IMRT, 70 Gy/33 fractions, with cisplatin 100 mg/m² on Day 1, Q3W × 2 cycles), and then adjuvant ivonescimab monotherapy (10 mg/kg Q3W × 9 cycles).
Primary Outcome Measure
Complete response rate (CRR) [ Time Frame: At the end of induction therapy ]
Central Contacts
- Jun Ma, M.D.+862087343469
- Lei Chen, M.D.