An interventional study of Multimodal Thermal Therapy (MTT) System and Toripalimab in Pancreatic Neoplasms and Neoplasm Metastasis, sponsored by Ruijin Hospital. Not yet recruiting at 5 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
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.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
This study's planned enrollment of 56 is above the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Ruijin Hospital is the lead sponsor of 679 studies on the registry; 387 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 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 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.
Conversion success rate
Percentage of subjects achieving successful conversion among all enrolled subjects
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From the first study intervention until 30 days after the last treatment or up to 24 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Toripalimab