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HIFU in combination with immunotherapy in patients with lung metastatic liver cancer

HIFU in combination with immunotherapy in patients with lung metastatic liver cancer: a prospective, single-center phase II clinical study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061076
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-07-10
Completion date
Unknown
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer

Interventions

HIFU combined group:HIFU

Sponsors

Xiangtan Cental Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. Cytologically or pathologically verified not-small-cell lung cancer; 3. Patients with liver metastasis or recurrence after operation; 4. There is no gene mutation target for targeted therapy; 5. The ECOG score is 0-2; 6. At least two measurable tumors according to RECIST 1.1; 7. Asymptomatic or symptomatic brain metastases under control; 8. Laboratory indicators showed no HIFU or contraindications to immunotherapy and chemotherapy; 9. Informed consent was obtained; 10.Participants' agreement to use effective contraception during the beginning of the trial and 90 days post-dose;

Exclusion criteria

Exclusion criteria: 1. Mixed lung cancer including neuroendocrine tumors, sarcoma; 2. Other malignant tumors developed within 5 years; 3. Uncontrolled pleural or pericardial effusion; 4. There were severe interstitial pneumonia and severe diffusion dysfunction in the lungs. 5. In liver failure; 6. Patients with autoimmune diseases requiring long-term hormone therapy; 7. Acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 1 month; 8. Patients who are pregnant or breastfeeding; 9. Life expectancy of 3 months or less;

Design outcomes

Primary

MeasureTime frame
ORR, Objective Remission Rate;

Secondary

MeasureTime frame
OS, Overall Survival;DCR, Disease Control Rate;safety of life;quality of life;PFS, Progression-Free Survival;

Countries

China

Contacts

Public ContactMingyan Jiang

Xiangtan Central Hospital

jiangmingyan1979@163.com+86 137 6221 8012

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026