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Trial Title:
Cryoablation Combined With Cardonilizumab and Bevacizumab in Hepatocellular Carcinoma With Pulmonary Metastases
NCT ID:
NCT06265350
Condition:
Hepatocellular Carcinoma
Liver Cancer Stage IV
Pulmonary Metastases
Cadonilimab
Bevacizumab
Cryoablation
Conditions: Official terms:
Carcinoma
Neoplasm Metastasis
Carcinoma, Hepatocellular
Lung Neoplasms
Bevacizumab
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cadonilimab
Description:
Cadonilimab, 375mg，Q3W， IV
Arm group label:
Bevacizumab+Cadonilimab group
Arm group label:
Cryoablation+Bevacizumab+Cadonilimab
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
Bevacizumab, 7.5mg/kg，Q3W， IV
Arm group label:
Bevacizumab+Cadonilimab group
Arm group label:
Cryoablation+Bevacizumab+Cadonilimab
Intervention type:
Procedure
Intervention name:
Cryoablation
Description:
Patients accepted Cryoablation of pulmanary metastases
Arm group label:
Cryoablation+Bevacizumab+Cadonilimab
Summary:
This study intends to evaluate the efficacy and safety of cryoablation combined with
Cardonilizumab and Bevacizumab in hepatocellular carcinoma with pulmonary metastases.
Detailed description:
For advanced hepatocellular carcinoma (HCC), the lung is the most common metastatic
organ, accounting for 30-50% of extrahepatic diseases. The standard therapy for advanced
HCC with lung metastases according to the Barcelona Clinic Liver Cancer (BCLC) criteria
is system therapy.
However, studies have proven that palliative ablation could improve the tumor controlling
effect and the outcomes.
Cryoablation is a treatment method that involves freezing tumors at extremely low
temperatures to destroy and eliminate them. This therapeutic approach can result in the
death of tumor cells through necrosis and also stimulate immune targeting of tumor cells.
These immune responses occur as a result of tumor cell death caused by the ablation
procedure. In comparison to conventional cancer therapies, cryoablation has minimal
adverse reactions and has the potential to promote a more extensive and effective release
of self-generated antigens into the bloodstream.
Targeting vascular endothelial growth factor (VEGF) could reduce VEGF-mediated
immunosuppression within the tumor. The IMbrave150 study of atezolizumab and bevacizumab
versus sorafenib demonstrated response rates of 29.8% vs 12%, respectively, and median
overall survival of 19.8 months in the combination arm versus 13.4 months in the
sorafenib (P <0.001). Bevacizumab could enhance anti-PD-1 and anti-programmed death
ligand 1 (PD-L1) efficacy by reversing VEGF-mediated immunosuppression and promoting
T-cell infiltration in tumors (2).
Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and
CTLA-4, which has the potential to boost immune surveillance in tumors. Preclinical
studies have shown that its tetravalent design enhances its high binding activity in the
tumor microenvironment. With no Fc binding, Cadonilimab could eliminate a series of
functions mediated by the Fc receptor, which contribute to a poor safety profile in
clinical settings.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. primary or recurrent HCC;
2. synchronous metastases (within one month after diagnosing of HCC) or asynchronous
metastases (more than one month after diagnosis of HCC);
3. pulmonary-only metastases >5 and ≤10;
4. metastases diameter ≤ 5 cm;
5. intrahepatic tumors ≤5, and tumor burden ≤1/2 liver volume;
6. PVTT type Vp≤3;
7. patients underwent first-line system therapy failure, the first-line system included
tyrosine kinase inhibitor (TKI), such as Sorafenib or Lenvatinib, with or without
PD-1 or PDL1 inhibitor;
8. the intrahepatic tumors were effectively controlled and pulmonary metastases were no
progression, and the controlled intrahepatic tumors were defined as partial or
stable response according to modified Response Evaluation Criteria in Solid Tumors
(mRECIST);
9. locoregional therapy (including TACE or HAIC) were also included;
10. Child-Pugh class A or B;
11. PS 0 or 1;
12. no history of other malignancies.
Exclusion Criteria:
1. under 18 years or over 75 years;
2. metastases >10
3. non-lung metastases;
4. incomplete clinical data;
5. metastases diameter > 5 cm;
6. intrahepatic tumors > 5, and tumor burden > 1/2 liver volume;
7. PVTT type Vp 4;
8. lost to follow-up within 3 months.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guanzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Qunfang Zhou, MD
Phone:
86 19868000115
Email:
zhouqun988509@163.com
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guanzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Qunfang Zhou, MD
Phone:
8619868000115
Email:
zhouqun988509@163.com
Start date:
February 2, 2024
Completion date:
January 30, 2027
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06265350
