A Multicenter, Prospective Single-arm Study of Multimodal Thermal Therapy Combined With Toripalimab and AG Chemotherapy in the Treatment of Advanced Pancreatic Cancer
Pancreatic Neoplasms · Neoplasm Metastasis
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - 75 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 56 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
Treatment Group
multimodal thermal therapy combined with TIS (Toripalimab) and AG chemotherapy (gemcitabine plus nab-paclitaxel)
Device: Multimodal Thermal Therapy (MTT) System · Drug: Toripalimab · Drug: Gemcitabine and Nab-Paclitaxel
Multimodal Thermal Therapy (MTT) System DEVICE
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.
Toripalimab DRUG
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.
Gemcitabine and Nab-Paclitaxel DRUG
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 researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Conversion success rate
Time frame: 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
Percentage of subjects achieving successful conversion among all enrolled subjects
Secondary measures
Progression-Free Survival(RECIST 1.1)
Time frame: From the start of treatment until documented disease progression or death, assessed up to 2 years
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.
Recurrence-Free Survival
Time frame: From the date of radical surgical resection until disease recurrence or death from any cause, assessed up to 2 years
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.
Overall Survival
Time frame: up to approximately 24 months
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.
Objective Response Rate
Time frame: up to approximately 24 months
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.
Incidence of Adverse Events
Time frame: From the first study intervention until 30 days after the last treatment or up to 24 months
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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (5)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
5 locations
The Affiliated Hospital of Qingdao University Medical CollegeQingdao, Shandong, ChinaStatus unknown
Ruijin Hospital, Shanghai Jiao Tong University School of MedicineShanghai, Shanghai Municipality, ChinaStatus unknown
Shanghai General HospitalShanghai, Shanghai Municipality, ChinaStatus unknown
The First Affiliated Hospital of Xi'an Jiaotong University School of MedicineXi’an, Shanxi, ChinaStatus unknown
West China Hospital, Sichuan UniversityChengdu, Sichuan, ChinaStatus unknown
Study team and timeline
- Lead sponsor
- Ruijin Hospital
- Study start
- Oct 28, 2026 Estimated
- Primary completion
- Dec 31, 2027 Estimated
- Study completion
- Aug 30, 2029 Estimated
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
A Multicenter, Prospective Single-arm Study of Multimodal Thermal Therapy Combined With Toripalimab and AG Chemotherapy in the Treatment of Advanced Pancreatic Cancer
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026