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Efficacy and safety of HIFU combined with immune checkpoint inhibitors in the treatment of platinum-resistant ovarian cancer: a prospective, single-center, single-arm clinical trial

Efficacy and safety of HIFU combined with immune checkpoint inhibitors in the treatment of platinum-resistant ovarian cancer: a prospective, single-center, single-arm clinical trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600127229
Enrollment
Unknown
Registered
2026-06-26
Start date
2024-11-18
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

ovarian cancer

Interventions

Observation group:None

Sponsors

Suining Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Fully understands the nature, significance, potential benefits, possible inconveniences, and potential risks and discomforts of the trial; voluntarily participates in this clinical trial; can communicate effectively with the investigators; agrees to comply with all study requirements; and has signed a written informed consent form. 2.Age 18-75 years (at the time of signing the informed consent form); ECOG performance status score of 0-1; expected survival time >=3 months. 3.Histopathologically or cytologically confirmed diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. 4.The subject experienced disease recurrence or progression during prior platinum-based chemotherapy or within 6 months after the last dose of platinum-based chemotherapy (at least 4 cycles). Note: The definition of disease recurrence or progression must meet either of the following two criteria: (1)Evidence of objective radiological or clinical disease progression (e.g., cytology report indicating new ascites or pleural effusion); (2)Sustained elevation of the tumor marker CA125 (confirmed after 1 week) accompanied by clinical symptoms or physical examination findings suggestive of disease progression. 5.No more than 5 prior lines of chemotherapy, and no more than 3 systemic treatment regimens are allowed after developing platinum resistance. 6.No severe organ dysfunction; no contraindications to HIFU or immunotherapy; meets the indications for HIFU treatment, and the size of the recurrent lesion is suitable for HIFU therapy. 7.At least one measurable target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by imaging (including CT, MRI, PET-CT, etc.). 8.Complete clinical data are available, and the subject is willing to undergo follow-up.

Exclusion criteria

Exclusion criteria: 1.Non-epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; 2.Contraindications to immunotherapy or HIFU therapy; presence of other malignant tumors or severe chronic diseases; 3.Unwilling to undergo follow-up; 4.Symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage procedures; 5.Pregnant or lactating women, or those with a positive pregnancy test; 6.Patients currently participating in or having recently participated in other clinical studies, or those who have received investigational or new therapies within 12 weeks prior to signing the informed consent form, or patients unwilling to refrain from participating in other studies; 7.Patients with new clinical conditions, significant changes in pre-existing medical conditions, abnormal laboratory findings, or those requiring new treatments or medications (where such treatments or medications meet any of the aforementioned exclusion criteria, or where the investigator believes participation could pose a risk to the patient).

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Safety;progression-free survival;Disease control rate;Overall survival;Disease remission period;

Countries

China

Contacts

Public ContactXiaomei Liu

Suining Central Hospital

87924552@qq.com+86 135 1836 5287

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026