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Ivonescimab (PD-1/VEGF Bispecific Antibody) Plus Radiofrequency Ablation for Multiple Advanced Tumors After PD-1 Therapy Failure | Clinical Trials | Clareo Health

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Ivonescimab (PD-1/VEGF Bispecific Antibody) Plus Radiofrequency Ablation for Multiple Advanced Tumors After PD-1 Therapy Failure

Ivonescimab (PD-1/VEGF Bispecific Antibody) Plus Radiofrequency Ablation for Multiple Advanced Tumors After PD-1 Therapy Failure: A Multicohort, Multicenter, Single-Arm Phase II Study

NCT07095803•Sheng Zhang

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if the combination of radiofrequency ablation (RFA) and Ivonescimab (PD-1/VEGF Bispecific Antibody) works to could reverse PD-1/PD-L1 resistance in patients with advanced tumors. It will also learn about the safety of this combination. The main questions it aims to answer are: Does the combination of RFA and Ivonescimab increase the objective response rate (ORR) of participants? What medical problems do participants have when taking the combination? Will the combination influence the progression-free survival time (PFS) and overall survival time and quality of life (QoL) of participants? Participants will: Patients received RGA treatment for less than three lesions. Patients were treated with Ivonescimab (20mg/kg Q3W, every 3 weeks) within 1 week before and after radiofrequency treatment until disease progression or intolerable toxicity occurred, or Ivonescimab was used for 2 years. Treatment effects will be evaluated every 9 weeks for 1 year and every 12 weeks thereafter.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Voluntarily provide written informed consent
•Age ≥18 years old
•Histologically and/or cytologically confirmed advanced tumors as assessed by imaging or ultrasound
•ECOG score: 0-2
•At least one measurable lesion (according to RECIST criteria, the major diameter of non-lymph node lesions on CT scan ≥10 mm, and the minor diameter of lymph node lesions on CT scan ≥15 mm); There are other lesions that can be treated with radiofrequency
•Blood routine: Absolute Neutrophil Count (ANC) 1.5×10\^9/L, Platelet (PLT) ≥70×10\^9/L, Hemoglobin (HGB) ≥80g/L
•Liver function: serum Total Bilirubin (TBIL) ≤1.5× Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) ≤3×ULN, and AST and ALT ≤5.0 ULN in patients with liver metastasis; Serum albumin ≥28 g/L
•Renal function: serum Creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥50 mL/mi (using the standard Cockcroft-Gault formula) 9. Coagulation: International Normalized Ratio (INR) ≤1.5 /PT≤1.5×ULN, aPTT≤1.5×ULN
•Estimated survival time ≥3 months
•Use of a medically approved contraceptive method is required during the study treatment period and for at least 120 days after the end of the study, and sperm donation or cryopreservation for fertilization and reproduction is not permitted during this period
+20 more criteria

Exclusion Criteria

•Subjects with any severe and/or uncontrolled illness. These include:
•1. poor blood pressure control (systolic blood pressure ≥150 MMHG or diastolic blood pressure ≥100 MMHG); Poorly controlled diabetes (fasting blood glucose \[FBG\] \> 10mmol/L);
•2. with ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia (QTc≥470ms), and ≥ grade 2 congestive heart failure (New York Heart Association \[NYHA\] classification); And 3) severe active or uncontrolled infections (≥CTCAE grade 2 infection) requiring systemic antibacterial, antifungal, or antiviral therapy, including pulmonary tuberculosis infection.
•4\) patients with a history of active tuberculosis; 5) If it is not controlled, ascites, pericardial effusion and pleural effusion still need repeated drainage

Key Dates

Start Date

August 1, 2025

Primary Completion Date

February 1, 2026

Completion Date

February 1, 2027

Last Updated

July 31, 2025

Enrollment

ESTIMATED participants

Conditions

Multiple Advanced Tumors After PD-1 Therapy Failure

Interventions

Ivonescimab (20mg/kg Q3W)

DRUG

radiofrequency ablation

PROCEDURE

Contacts

Dr. Sheng Zhang

CONTACT

86-18017317442 wozhangsheng@hotmail.com