NCT06265350Recruiting
Cryoablation Combined With Cardonilizumab and Bevacizumab in Hepatocellular Carcinoma With Pulmonary Metastases
Cryoablation Combined With Cardonilizumab and Bevacizumab in Hepatocellular Carcinoma With Pulmonary Metastases: A Single-center, Prospective, Randomized Controlled Phase II Study
Source: ClinicalTrials.gov · Last updated 20 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study intends to evaluate the efficacy and safety of cryoablation combined with Cardonilizumab and Bevacizumab in hepatocellular carcinoma with pulmonary metastases.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 2 Feb 2024
- Start date
- 2 Feb 2024
- Primary completion date
- 30 Jan 2026
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06265350
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 2 Feb 2024 to the primary completion date, 30 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guanzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.