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Efficacy and Safety of Multi-mode Thermal Therapy Combined with Paclitaxel plus Gemcitabine (AG Regimen) as First-Line Treatment for Pancreatic Cancer with Liver Metastases: A Prospective Single-Arm Study

Efficacy and Safety of Multi-mode Thermal Therapy Combined with Paclitaxel plus Gemcitabine (AG Regimen) as First-Line Treatment for Pancreatic Cancer with Liver Metastases: A Prospective Single-Arm Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111957
Enrollment
Unknown
Registered
2025-11-07
Start date
2025-11-10
Completion date
Unknown
Last updated
2025-11-11

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

Conditions

pancreatic cancer with liver metastasis

Interventions

Testt Group:Multi-modal ablation combined with the AG regimen and sintilimab

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years, regardless of gender; 2. Patients with newly diagnosed pancreatic cancer with liver metastasis confirmed by pathology or meeting clinical diagnostic criteria, without metastasis to other organs except the liver; 3. The number of liver metastatic lesions 3 months.

Exclusion criteria

Exclusion criteria: 1. Patients who have previously received radiotherapy, surgery, chemotherapy, or investigational treatment for metastatic disease (patients who have previously received gemcitabine or fluorouracil adjuvant chemotherapy are eligible for enrollment if the treatment has been completed and the interval from the end of treatment to the start of the first study treatment exceeds 6 months); 2. Patients who have participated in other clinical trials in the past 4 weeks; 3. Diffuse liver metastasis; 4. Liver function classified as Child-Pugh Class C, or severe jaundice (especially obstructive jaundice); patients are eligible for enrollment if bilirubin is significantly reduced and liver function, body temperature, and blood parameters return to normal after jaundice reduction treatment; 5. Severe hepatic or renal insufficiency and coagulation disorders (serum creatinine > 176.8 µmol/L or creatinine clearance 18 seconds; prothrombin activity < 40%, and these conditions cannot be corrected); 6. Uncontrolled comorbidities, including poorly controlled hypertension or diabetes, persistent active infection, or mental illness or social conditions that may affect the subject’s compliance with the study; 7. Refractory massive ascites, pleural effusion, or cachexia; 8. Pregnancy or lactation; 9. Other factors that, in the investigator’s opinion, make the subject unsuitable for enrollment or affect their participation in the study.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;

Secondary

MeasureTime frame
Complete Ablation Rate;Progression-Free Survival;Overall Survival;Immune Indicator Changes;Adverse Event;

Countries

China

Contacts

Public ContactXiao Hu

The Affiliated Hospital of Qingdao University

huxiao202@163.com+86 186 6180 8808

Outcome results

None listed

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