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NCT07064902PHASE2NOT_YET_RECRUITING

Ivonescimab Combined With Chemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma

Ivonescimab Combined With Chemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase II, Multicenter, Single-Arm Clinical Trial

Sponsor: Sun Yat-sen University

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type
INTERVENTIONAL
Conditions
Nasopharyngeal Carcinoma (NPC)
Interventions
Ivonescimab(AK112,a PD-1/VEGF bispecific antibody)
Enrollment
48 participants
Primary completion
Aug 2026
Study completion
Jun 2028
First posted
Jul 2025
Last updated
Jul 2025

Primary Endpoints (CT.gov)

Complete response rate (CRR)

Time frame: At the end of induction therapy

Secondary Endpoints

Objective response rate (ORR)

Failure-free survival (FFS)

Overall survival (OS)

Eligibility Criteria

Inclusion Criteria: 1. Age between 18 and 65 years. 2. Histologically confirmed non-keratinizing carcinoma (according to WHO classification). 3. ECOG performance status of 0 or 1. 4. Previously untreated nasopharyngeal carcinoma staged as T3N2M0 or Stage III according to the AJCC 9th edition. 5. Adequate bone marrow function, defined as white blood cell count \> 4×10⁹/L, hemoglobin \> 90 g/L, and platelet count \> 100×10⁹/L. 6. Adequate liver and renal function, defined as total bilirubin ≤ 1.5 × ULN; AST and/or ALT ≤ 2.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; and creatinine clearance ≥ 60 mL/min. 7. Normal thyroid function, amylase, lipase, pituitary function, inflammatory markers, myocardial enzymes, and ECG. For patients over 50 years old with a smoking history, pulmonary function test results must be normal. For patients with ECG abnormalities or a cardiovascular history not meeting exclusion criteria #8, echocardiography and cardiac function tests must be normal. 8. Signed info

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov