Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT06265350
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06265350
Study Brief:
Protocol Section:
NCT06265350