A Multicenter, Prospective Single-arm Study of Multimodal Thermal Therapy Combined With Toripalimab and AG Chemotherapy in the Treatment of Advanced Pancreatic Cancer
Key facts
- Where
- Chengdu, Qingdao, Shanghai, and Xi'an, ChinaSee the 5 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07928362, who can take part
Where in China
- West China Hospital，Sichuan UniversityChengdu, ChinaNo longer taking part
- The Affiliated Hospital of Qingdao University Medical CollegeQingdao, ChinaNo longer taking part
- Ruijin Hospital, Shanghai Jiao Tong University School of MedicineShanghai, ChinaNo longer taking part
- Shanghai General HospitalShanghai, ChinaNo longer taking part
- The First Affiliated Hospital of Xi'an Jiaotong University School of MedicineXi'an, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ruijin Hospital
- Trial code
- NCT07928362
- Record updated
- 10 November 2026
- Original description
This study is a multicenter, prospective, single-arm, open-label, Simon two-stage phase II clinical trial designed to evaluate the conversion therapeutic value of multimodal thermal therapy combined with TIS (Toripalimab) and AG chemotherapy (gemcitabine plus nab-paclitaxel) in previously untreated metastatic pancreatic cancer patients with liver-only or lung-only metastases.Read full original descriptionShow less
This study is a multicenter, prospective, single-arm, open-label, Simon two-stage phase II clinical trial designed to evaluate the conversion therapeutic value of multimodal thermal therapy combined with TIS (Toripalimab) and AG chemotherapy (gemcitabine plus nab-paclitaxel) in previously untreated metastatic pancreatic cancer patients with liver-only or lung-only metastases.
Inclusion: 1. Aged 18-75 years, regardless of gender; 2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma; 3. Metastatic pancreatic cancer assessed by MDT as initially unresectable, with metastases confined solely to the liver or lungs, and no metastases to other organs beyond the liver or lungs; 4. Liver or lung metastases: number of lesions ≤ 3, and maximum diameter of each lesion ≤ 3 cm; 5. No prior systemic therapy for pancreatic cancer; 6. ECOG PS 0-1; 7. Child-Pugh score ≤ 7; 8. Voluntarily signed informed consent form.
Exclusion: 3. Diagnosis of any other malignant disease other than pancreatic cancer within 5 years prior to the first dose (excluding cured cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ); 5. Suffering from any disease requiring systemic treatment with corticosteroids (prednisone or equivalent at a daily dose >10 mg) or other immunosuppressive drugs within 14 days prior to enrollment; 6. Previous or current diagnosis of brain metastases with symptoms not fully controlled (i.e., persistent or worsening symptoms, or requiring adjustment of symptomatic treatment to maintain symptom relief); 4. History of solid organ or hematopoietic stem cell transplantation; 7. Uncontrolled active infection; 10. History of ruptured esophagogastric varices that have not been effectively treated by endoscopy, interventional therapy, or surgery; 11. Patients with psychiatric disorders in the active phase; 8. Renal dysfunction: serum creatinine >176.8 μmol/L or creatinine clearance <30 ml/min; 9. Uncorrectable abnormal coagulation function: platelet count <50×10⁹/L, prothrombin time >18 s, prothrombin activity <40%, and uncorrectable; 12. Pregnant or lactating women, or women of childbearing age who plan to become pregnant within 3 months after the end of study treatment; 1. Diffuse hepatic/pulmonary metastasis; 2. Participation in another interventional clinical study treatment within 4 weeks; 13. Expected survival <3 months; 14. Any other factors that the investigator deems unsuitable for inclusion or that may affect the subject's participation in the study.