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

ConditionMultiple Advanced Tumors After PD-1 Therapy Failure
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSheng Zhang

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

poor blood pressure control (systolic blood pressure ≥150 MMHG or diastolic blood pressure ≥100 MMHG); Poorly controlled diabetes (fasting blood glucose [FBG] > 10mmol/L);

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.

Active hepatitis (transaminase did not meet the inclusion criteria, hepatitis B reference: HBV DNA≥2000 IU/ml or ≥104 copies /ml; Hepatitis C reference: HCV RNA≥2000 IU/ml or ≥104 copies /ml; After nucleotide antiviral therapy, those below the above criteria can be enrolled). Chronic hepatitis B virus carriers with HBV DNA < 104 IU/ml could only be enrolled if they received antiviral therapy at the same time during the trial

A history of immunodeficiency, including HIV infection or other acquired or congenital immunodeficiency diseases

Trial design

Design model

Single group

Treatments tested in this trial

  • Ivonescimab (20mg/kg Q3W)

    Drug

    Patients received intravenous everciximab (20mg/kg Q3W) within 1 week before and after radiofrequency ablation.

  • radiofrequency ablation

    Procedure/Surgery

    Patients received radiofrequency treatment for less than three lesions.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: 1Experimental treatment 2 interventions
Group B: 2Experimental treatment 2 interventions
Group C: 3Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The proportion of patients who achieved CR or PR according to RECIST V.1.1 criteria.

Objective Response Rate (ORR)

Time frame
Efficacy was assessed every 9 weeks for 1 year and every 12 weeks thereafter (assessed up to 3 years).

Secondary outcomes

1

Time from treatment start to progression by RECIST V.1.1.

Progression-free survival(PFS)

Time frame
From date of treatment until the date of first documented progression, assessed up to 100 months.
2

Time from treatment start to death of participants.

Overall Survival(OS)

Time frame
From date of treatment until the date of death from any cause, whichever came first, assessed up to 100 months.
3

Type, incidence, severity, onset and end time of adverse events (AE) evaluated according by the version 5.0 of NCI-CTCAE.

Evaluation of safety

Time frame
Began at 30 days (±7 days) after the last study treatment to 1 year.
4

Scores based on the assessment of FACT-P, version 4.

Quality of Life (QoL) among participants. Scores based on the assessment of FACT-P, version 4, range from 0-156 points. Higher scores mean a better outcome.

Time frame
Assessments were performed every 6 weeks during the screening period and during treatment (assessed up to 1 year).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sheng Zhang

Lead sponsor

Fudan University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: