A Multicenter, Prospective Single-arm Study of Multimodal Thermal Therapy Combined With Toripalimab and AG Chemotherapy in the Treatment of Advanced Pancreatic Cancer (SMP1-13115)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neoplasm Metastasis; Pancreatic Neoplasms
• Intervention / Treatment: Device: Multimodal Thermal Therapy (MTT) System; Drug: Toripalimab; Drug: Gemcitabine and Nab-Paclitaxel

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: baiyong shen; Phone Number: +86 18817821319; Email: shenby@shsmu.edu.cn

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China
      • The Affiliated Hospital of Qingdao University Medical College
      • Contact: xiao hu; Phone Number: +86 53282911869; Email: 8371270@qq.com
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200000
      • Shanghai General Hospital
      • Contact: jiang long; Phone Number: +86 18017317460; Email: jiang.long@shgh.cn
    • Shanghai, Shanghai Municipality, China, 200000
      • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: baiyong shen; Phone Number: +86 18817821319; Email: shenby@shsmu.edu.cn
  • Shanxi
    • Xi’an, Shanxi, China
      • The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine
      • Contact: zheng wang; Phone Number: 400-000-3222
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital, Sichuan University
      • Contact: zhong wu; Phone Number: +86 18980606518; Email: wuzhong057@scu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 1. Diffuse hepatic/pulmonary metastasis;
• 2. Participation in another interventional clinical study treatment within 4 weeks;
• 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);
• 4. History of solid organ or hematopoietic stem cell transplantation;
• 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);
• 7. Uncontrolled active infection;
• 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;
• 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;
• 12. Pregnant or lactating women, or women of childbearing age who plan to become pregnant within 3 months after the end of study treatment;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment Group; multimodal thermal therapy combined with TIS (Toripalimab) and AG chemotherapy (gemcitabine plus nab-paclitaxel)

Device: Multimodal Thermal Therapy (MTT) System; The MTT system is a medical device that performs sequential ablation therapy. Treatment consists of initial cryoablation followed immediately by radiofrequency ablation (RFA) to achieve a synergistic thermal effect against the tumor.; Drug: Toripalimab; Toripalimab is a humanized IgG4 monoclonal antibody against programmed death-1 (PD-1). It is administered via intravenous infusion at a standard dose according to the protocol to block the PD-1/PD-L1 pathway and enhance anti-tumor immunity.; Drug: Gemcitabine and Nab-Paclitaxel; Gemcitabine combined with nab-paclitaxel (albumin-bound paclitaxel) is a standard chemotherapy regimen for advanced pancreatic cancer. Both drugs are administered via intravenous infusion according to the clinical protocol to inhibit cancer cell proliferation and division.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversion success rate	Percentage of subjects achieving successful conversion among all enrolled subjects	From the start of treatment (Multimodal Thermal Therapy) until the evaluation of surgical conversion following at least 4 cycles of subsequent combination therapy, assessed up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival(RECIST 1.1)	Time from the start of treatment until disease progression (according to RECIST 1.1 based on enhanced abdominal/chest-abnormal CT or MRI every 6-8 weeks) or death from any cause, whichever occurs first.	From the start of treatment until documented disease progression or death, assessed up to 2 years
Recurrence-Free Survival	From the date of radical surgical resection to the first confirmed disease recurrence by imaging or pathology, or death from any cause, whichever occurs first. Disease recurrence, including local recurrence and distant metastasis, is assessed by imaging examinations (CT/MRI ± PET-CT) or confirmed by histopathological evidence. For patients without recurrence, follow-up data will be censored at the date of the last disease assessment.	From the date of radical surgical resection until disease recurrence or death from any cause, assessed up to 2 years
Overall Survival	Time from the date of first study intervention to the date of death from any cause or the date of the last confirmed survival follow-up. Long-term survival will be tracked through regular follow-up visits until death, loss to follow-up, or study termination.	up to approximately 24 months
Objective Response Rate	Imageological evaluation was conducted according to the RECIST 1.1 criteria for solid tumors. Target lesions included both the primary pancreatic tumor in situ and measurable metastatic lesions in the liver or lungs. Quantitative measurement of the longest diameter of each target lesion was performed using contrast-enhanced CT or MRI, and the sum of the longest diameters was calculated to determine the change, thereby assessing tumor response.	up to approximately 24 months
Incidence of Adverse Events	The incidence, severity, and type of adverse events (AEs) and serious adverse events (SAEs) evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v6.0), as well as changes in laboratory tests, vital signs, and physical examinations.	From the first study intervention until 30 days after the last treatment or up to 24 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 28, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): August 30, 2029

Study Registration Dates

• First Submitted: November 5, 2026
• First Submitted That Met QC Criteria: November 5, 2026
• First Posted (Actual): November 10, 2026

Study Record Updates

• Last Update Posted (Actual): November 10, 2026
• Last Update Submitted That Met QC Criteria: November 5, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: Metastatic pancreatic cancer; First-line therapy; Multimodal Thermal Therapy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Pancreatic Neoplasms; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Drug Therapy; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Gemcitabine; Drug Delivery Systems; toripalimab; 130-nm albumin-bound paclitaxel
• Other Study ID Numbers: SMP1-13115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No