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Cryoablation Combined With Cardonilizumab and Bevacizumab in Hepatocellular Carcinoma With Pulmonary Metastases

ConditionsHepatocellular CarcinomaLiver Cancer Stage IVPulmonary MetastasesCadonilimabBevacizumabCryoablation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

This study intends to evaluate the efficacy and safety of cryoablation combined with Cardonilizumab and Bevacizumab in hepatocellular carcinoma with pulmonary metastases.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

primary or recurrent HCC;

synchronous metastases (within one month after diagnosing of HCC) or asynchronous metastases (more than one month after diagnosis of HCC);

pulmonary-only metastases >5 and ≤10;

metastases diameter ≤ 5 cm;

Disqualifiers

under 18 years or over 75 years;

metastases >10

non-lung metastases;

incomplete clinical data;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cadonilimab

    Drug

    Cadonilimab, 375mg，Q3W， IV

  • Bevacizumab

    Drug

    Bevacizumab, 7.5mg/kg，Q3W， IV

  • Cryoablation

    Procedure/Surgery

    Patients accepted Cryoablation of pulmanary metastases

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Bevacizumab+Cadonilimab groupActive comparator 2 interventions
Group B: Cryoablation+Bevacizumab+CadonilimabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

ORR, as determined based on tumor response according to RECIST 1.1, is defined as partial response and complete response.

Time frame
6 months

Secondary outcomes

1

Progression free survival (PFS)

PFS is defined as the time from the date of inclusion to the date of the first objectively documented tumor progression or death due to any cause.

Time frame
6 months
2

Overall survival (OS)

OS is the length of time from the date of inclusion until death from any cause.

Time frame
12 months

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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