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

Sponsor
Sheng Zhang
Study ID
NCT07095803
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Multiple Advanced Tumors After PD-1 Therapy Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ivonescimab (20mg/kg Q3W) — DRUG
    Patients received intravenous everciximab (20mg/kg Q3W) within 1 week before and after radiofrequency ablation.
  • radiofrequency ablation — PROCEDURE
    Patients received radiofrequency treatment for less than three lesions.

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
Jul 2025
Primary completion
Feb 1, 2026
Completion
Feb 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Patients with advanced tumors who had been evaluated as effective on PD1 or PD1 combined with targeted therapy (CR,PR, or SD for more than 6 months on PD1 therapy) and then progressed on PD1 therapy or progressed less than 3 months after drug withdrawal;
  • Experimental: 2
    Patients with advanced tumors who had been evaluated as having a response to PD1 or PD1 combined targeted therapy (CR,PR, or SD for more than 6 months on PD1 therapy) and then progressed more than 3 months after drug withdrawal.
  • Experimental: 3
    Patients with advanced tumors who failed to respond to PD1 or PD1 combined with targeted therapy (the effect of PD1 therapy was PD or SD \< 6 months).

Primary Outcome Measure

The proportion of patients who achieved CR or PR according to RECIST V.1.1 criteria. [ Time Frame: Efficacy was assessed every 9 weeks for 1 year and every 12 weeks thereafter (assessed up to 3 years). ]

Central Contacts