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Synergistic effect of ultrasound therapy in chemotherapy for unresectable pancreatic cancer

Synergistic effect of ultrasound therapy in chemotherapy for unresectable pancreatic cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090269
Enrollment
Unknown
Registered
2024-09-26
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-10-15

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

Conditions

pancreatic cancer

Interventions

chemotherapy alone group:Chemotherapy was performed using mFOLFIRINOX regimen
Ultrasound treatment + chemotherapy group:Chemotherapy with mFOLFIRINOX regimen combined with ultrasound therapy

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Unresectable with or without distant metastasis confirmed by pathology or cytology (stage IV) of patients with pancreatic cancer, regardless of the number of metastases; 2. Age 18-75 years old, male or female; 3. Imaging assessment (ultrasound, CT or MRI) showed measurable and evaluable tumor lesions; 4. ECOG score 0-1, estimated survival period of more than 3 months; 5. No obvious abnormalities in liver and kidney function: ALT, AST= 2.5 times the upper limit of normal values, Urea, Cr= above normal values The limit is 1.25 times, and ALT and AST in patients with liver metastasis are = 5 times the upper limit of normal; 6.WBC=3.5 ×10^9/L,PLT=80 ×10^9/L,Hb=90 g/L; 7. No history of other malignant tumors; 8. Women of childbearing age must undergo a pregnancy test within 7 days before enrollment; 9. The patient signed the informed consent form agreeing to participate in the trial, was able to be followed up, and compliance was good.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactation; 2. Allergy and hypersensitivity to chemotherapeutic drugs; 3. Suffering from severe cardiopulmonary dysfunction; 4. Intestinal obstruction or incomplete ileus; 5. Accompanied by a large amount of ascites; 6. Accompanied by brain and bone metastases; 7. Are receiving treatment with other antitumor drugs or radiotherapy; 8. Participating in other clinical trials at the same time or completing chemotherapy within 4 weeks.

Design outcomes

Primary

MeasureTime frame
overall survival;

Secondary

MeasureTime frame
progression-free survival;duration of response;objective response rate;disease control rate;

Countries

China

Contacts

Public ContactLi Kai

The Third Affiliated Hospital of Sun Yat-sen University

likai@mail.sysu.edu.cn+86 189 2210 3579

Outcome results

None listed

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