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A Comparative Study on the Efficacy of High-Intensity Focused Ultrasound Ablation (FUS) Combined with Chemotherapy versus Chemotherapy Alone in the Treatment of Unresectable Pancreatic Cancer

A Comparative Study on the Efficacy of High-Intensity Focused Ultrasound Ablation (FUS) Combined with Chemotherapy versus Chemotherapy Alone in the Treatment of Unresectable Pancreatic Cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107442
Enrollment
Unknown
Registered
2025-08-12
Start date
2025-08-15
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Pancreatic Cancer

Interventions

Focused Ultrasound Surgery (FUS) combined with chemotherapy group:NA
chemotherapy alone group:NA

Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Having given personal consent and signed the informed consent form, and being willing and able to comply with the planned visits, study treatments, laboratory tests, and other trial procedures; (2) Patients with pancreatic cancer confirmed by histopathology or clinically diagnosed by enhanced computed tomography (CT), magnetic resonance imaging (MRI), or other relevant examinations; (3) Diagnosed as stage III/IV according to the 2018 NCCN Guidelines (Version 8) for pancreatic cancer TNM staging criteria; (4) Unresectable by radical pancreatic cancer surgery; (5) Aged 18 to 75 years; (6) No previous history of radical surgical treatment, radiotherapy, or systemic therapy for pancreatic cancer; (7) Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; (8) Having clearly measurable lesions that meet the requirements of the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1), with the maximum diameter >= 20 mm; (9) Expected survival time of at least 12 weeks; (10) Planned to receive treatment with "gemcitabine + nab-paclitaxel", "liposomal irinotecan (II) + oxaliplatin + fluorouracil + leucovorin", "oral capecitabine", or "oral tegafur-gimeracil-oteracil potassium", either alone or in combination with FUS.

Exclusion criteria

Exclusion criteria: (1) Having previously received radiotherapy or focused ultrasound surgery (FUS) within 12 weeks; (2) Not eligible for treatment with "gemcitabine + nab-paclitaxel", "liposomal irinotecan (II) + oxaliplatin + fluorouracil + leucovorin", "oral capecitabine", or "oral tegafur-gimeracil-oteracil potassium", either alone or in combination with FUS; (3) Pregnant or lactating women; (4) Patients with other severe physical or mental illnesses, or abnormal laboratory test results, which may increase the risk of participating in the study, interfere with the study results, or are deemed unsuitable for participation in this study by the researchers.

Design outcomes

Primary

MeasureTime frame
Overall survival, OS;

Secondary

MeasureTime frame
progression-free survival, PFS;objective response rate, ORR;disease control rate, DCR;safety;pain intensity;

Countries

China

Contacts

Public ContactYunfei Liu

The Third Xiangya Hospital of Central South University

liuyunfeix1@126.com+86 185 6942 5298

Outcome results

None listed

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