This trial aims to study the role of Ivonescimab combined with chemoradiotherapy in high-Risk locoregionally advanced nasopharyngeal carcinoma.
Age between 18 and 65 years.
Histologically confirmed non-keratinizing carcinoma (according to WHO classification).
ECOG performance status of 0 or 1.
Previously untreated nasopharyngeal carcinoma staged as T3N2M0 or Stage III according to the AJCC 9th edition.
Signed informed consent and willingness to comply with all scheduled visits, treatment procedures, laboratory tests, and other study-related requirements.
Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use reliable contraception from screening until 1 year after completion of treatment.
Tumor invasion of major blood vessels or significant recent (within 1 month) nasopharyngeal or nasal bleeding (>5 mL).
HBsAg positive with HBV DNA > 1×10³ copies/mL, or anti-HCV antibody positive.
Single group
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.
Complete response rate (CRR)
Disappearance of all target lesions, with all pathological lymph nodes (including both target and non-target nodes) reduced in short axis to less than 10 mm.
Objective response rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of patients who achieve either a Complete Response (CR) or a Partial Response (PR) as assessed per RECIST v1.1 criteria.
Failure-free survival (FFS)
calculated from enrolment to the date of locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first.
Overall survival (OS)
calculated from enrolment to the date of death from any cause.
Distant metastasis-free survival (DMFS)
calculated from enrolment to the date of first distant metastasis.
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This trial is not recruiting at the moment. You can still explore other options:
