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Phase I / II clinical study of HIFU combined with PD-1 inhibitor in the treatment of advanced cancer

Phase I / II clinical study of HIFU combined with PD-1 inhibitor in the treatment of advanced cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043123
Enrollment
Unknown
Registered
2021-02-05
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-05-24

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

Conditions

advanced cancer

Interventions

1:HIFU+PD-1 inhibitors

Sponsors

Mianyang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A. Aged >/=18 years; B. The patients were diagnosed as malignant tumor by histopathology; C. Immunotherapy (PD-1 antibody) after MDT discussion; D. ECoG PS score 0-2; E. At least one lesion can be ablated by HIFU, and more than one additional non continuous lesion can be monitored; F. There is no absolute contraindication of immunotherapy; G. Expected survival > 12 weeks.

Exclusion criteria

Exclusion criteria: A. The metastatic lesions were vertebral or intracranial, and there was no other lesion for HIFU ablation B. Serious heart, lung and kidney disease, unable to complete treatment; C. At the end of the life cycle, giving up the requirement for treatment; D. Unable to cooperate with treatment; E. It is expected that the skin pain response of the treatment access will be slow and loss; F. Patients who have previously received any immunotherapy.

Design outcomes

Primary

MeasureTime frame
Toxicity;objective response rate;PFS;Changes of lymphocyte count and immune markers in peripheral blood;

Secondary

MeasureTime frame
Quality of life;

Countries

China

Contacts

Public ContactDU Xiaobo

Mianyang Central Hospital

duxiaobo2005@126.com+86 13550282229

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026