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Phase I/II Clinical Study of Immunocheckpoint Inhibitor Combined with High Intensity Focused Ultrasound for Advanced Metastatic Esophageal Squamous Cell Carcinoma

Phase I/II Clinical Study of Immunocheckpoint Inhibitor Combined with High Intensity Focused Ultrasound for Advanced Metastatic Esophageal Squamous Cell Carcinoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047836
Enrollment
Unknown
Registered
2021-06-27
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-03-07

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

Conditions

esophageal cancer

Interventions

single-arm group:Immunocheckpoint Inhibitor Combined with High Intensity Focused Ultrasound

Sponsors

Mianyang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 18 years old and above; 2. Patients with advanced metastatic esophageal squamous cell carcinoma diagnosed by histopathology; 3. Intended for immune checkpoint inhibitor therapy (PD-1 antibody); 4. ECOG PS score 0-2 points; 5. At least one metastatic lesion available for HIFU ablation; 6. There is no absolute contraindication to immunotherapy; 7. Expected survival > 12 weeks.

Exclusion criteria

Exclusion criteria: 1. Patients without HIFU ablation safe acoustic channel; 2. Severe heart, lung and kidney disease, unable to complete the treatment; 3. Unable to cooperate with treatment; 4. It is expected that the skin pain response of the treatment pathway is unresponsive and lost; 5. Those who have received any immunotherapy before.

Design outcomes

Primary

MeasureTime frame
objective response rate;

Secondary

MeasureTime frame
Progression-free Survival;Overall Survival;safety;Peripheral blood lymphocyte count;Changes of immune markers;

Countries

China

Contacts

Public ContactGao Feng

Mianyang Central Hospital

edna_9999@163.com+86 18681630773

Outcome results

None listed

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