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)

November 5, 2026 updated by: Ruijin Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China
        • The Affiliated Hospital of Qingdao University Medical College
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Shanghai General Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200000
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
    • 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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
From the start of treatment until documented disease progression or death, assessed up to 2 years
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.
From the date of radical surgical resection until disease recurrence or death from any cause, assessed up to 2 years
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.
up to approximately 24 months
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.
up to approximately 24 months
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.
From the first study intervention until 30 days after the last treatment or up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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