NCT06265350

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable hepatocellular-carcinoma

Timeline
8mo left

Started Feb 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Feb 2024Jan 2027

First Submitted

Initial submission to the registry

February 2, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

February 2, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Expected
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

February 2, 2024

Last Update Submit

February 9, 2024

Conditions

Hepatocellular CarcinomaLiver Cancer Stage IVPulmonary MetastasesCadonilimabBevacizumabCryoablation

Outcome Measures

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.

    6 months

Secondary Outcomes (2)

  • Progression free survival (PFS)

    6 months

  • Overall survival (OS)

    12 months

Study Arms (2)

Bevacizumab+Cadonilimab group

ACTIVE COMPARATOR

Patients accepted Bevacizumab (7.5mg/kg，Q3W， IV) plus Cadonilimab (375mg，Q3W， IV)

Drug: CadonilimabDrug: Bevacizumab

Cryoablation+Bevacizumab+Cadonilimab

EXPERIMENTAL

Patients accepted Cryoablation of pulmanary metastases combined with Bevacizumab (7.5mg/kg，Q3W， IV) and Cadonilimab (375mg，Q3W， IV)

Drug: CadonilimabDrug: BevacizumabProcedure: Cryoablation

Interventions

CadonilimabDRUG

Cadonilimab, 375mg，Q3W， IV

Bevacizumab+Cadonilimab groupCryoablation+Bevacizumab+Cadonilimab
BevacizumabDRUG

Bevacizumab, 7.5mg/kg，Q3W， IV

Bevacizumab+Cadonilimab groupCryoablation+Bevacizumab+Cadonilimab
CryoablationPROCEDURE

Patients accepted Cryoablation of pulmanary metastases

Cryoablation+Bevacizumab+Cadonilimab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • intrahepatic tumors ≤5, and tumor burden ≤1/2 liver volume;
  • PVTT type Vp≤3;
  • 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;
  • 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);
  • locoregional therapy (including TACE or HAIC) were also included;
  • Child-Pugh class A or B;
  • PS 0 or 1;
  • no history of other malignancies.

You may not qualify if:

  • under 18 years or over 75 years;
  • metastases \>10
  • non-lung metastases;
  • incomplete clinical data;
  • metastases diameter \> 5 cm;
  • intrahepatic tumors \> 5, and tumor burden \> 1/2 liver volume;
  • PVTT type Vp 4;
  • lost to follow-up within 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sun Yat-sen University Cancer Center

Guanzhou, Guangdong, 510000, China

RECRUITING

Sun Yat-sen University Cancer Center

Guanzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Interventions

BevacizumabCryosurgery

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Zhimei Hunag, MD

    Sun Yat-sen University

    STUDY DIRECTOR

  • Jinhua Huang, MD

    Sun Yat-sen University

    STUDY DIRECTOR

Central Study Contacts

Qunfang Zhou, MD

CONTACT

86 19868000115zhouqun988509@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 2, 2024

First Posted

February 20, 2024

Study Start

February 2, 2024

Primary Completion

January 30, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations

CN(2)