Pancreatic CancerNCT06307080
Clinical Study of Multimodal Ablation Remodeling Immunosensitized PD-1 in the Treatment of Pancreatic Cancer With Liver Metastasis
A study testing Multi-mode thermal ablation device and Intravenous anti-PD-1 and chemotherapy in people with Pancreatic Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
1. Clinical evaluation of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies. 2. Construction of a combined treatment system of multimodal ablation therapy combined with immunotherapy and chemotherapy. 3. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Multi-mode thermal ablation device and Intravenous anti-PD-1 and chemotherapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-70 years old, gender is not limited;
- Newly diagnosed pancreatic cancer with liver metastasis confirmed by pathology or consistent with clinical diagnosis, and no metastases to organs other than the liver;
- Imaging evaluable tumors with safe access to puncture;
- The number of half liver tumors ≤3 and the size of each tumor ≤3 cm;
- ECOG PS score ≤2 points, expected survival > 3 months.
Who cannot join
- Liver function Child-Pugh grade C, severe jaundice, especially obstructive jaundice;
- The liver is significantly atrophy, the tumor is too large, and the ablation range needs to reach one-third of the liver volume;
- Expected survival < 3 months;
- serious heart, lung, liver and kidney dysfunction and coagulation dysfunction;
- Uncontrolled co-morbidities, including poorly controlled hypertension or diabetes, persistent active infections, or mental illness or social conditions that may affect participants' compliance with the study;
- refractory ascites, pleural fluid or bad fluid;
- Pregnancy or breastfeeding;
- The researcher considers that there are any other factors that are not suitable for inclusion or affect the participant's participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200040
Jiang Long, MD, +86 18017317460, jiang.long@shgh.cn
About this study
- Clinical evaluation of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies.
- Construction of a combined treatment system of multimodal ablation therapy combined with immunotherapy and chemotherapy.
- Transformation and clinical application of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies.
- Conditions
- Pancreatic Cancer
- Being tested
- Multi-mode thermal ablation device, Intravenous anti-PD-1 and chemotherapy
- Keywords
- liver metastases
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-mode thermal ablation deviceDevice
The tumor tissue was rapidly frozen until the ice ball exceeded 5mm of the lesion tissue, kept for 5 minutes, then thawed and warmed. Then, complete ablation was performed according to the radiofrequency temperature control mode of multimodal tumor therapy to ensure that the ablation area included a safe range of 5~10mm around the tumor.
Intravenous anti-PD-1 and chemotherapyDrug
intravenous anti-PD-1 and chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Multi-mode thermal ablation combined with intravenous anti-PD-1 and chemotherapy | Experimental | Multimodal ablation therapy +PD-1 antibody combined with intravenous chemotherapy was performed (carreilizumab 200 mg IV D1+ gemcitabine 1000mg/㎡ IV+ albumin binding paclitaxel 125mg/㎡ IV D1.8Q3W; For 6 weeks) Receives: Device: Multi-mode thermal ablation device; Drug: Intravenous anti-PD-1 and chemotherapy |
| Intravenous anti-PD-1 and chemotherapy | Active comparator | Intravenous chemotherapy was performed (carreilizumab 200 mg IV D1+ gemcitabine 1000mg/㎡ IV+ albumin binding paclitaxel 125mg/㎡ IV D1.8Q3W; For 6 weeks) Receives: Drug: Intravenous anti-PD-1 and chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy assessment
To evaluate the safety and efficacy of multimodal ablation therapy combined with immunotherapy
Measured: Up to 1 year after the treatment
Secondary outcomes (1)
Survival benefit
Effect on survival benefit of pancreatic cancer patients with liver metastasis
Measured: Up to 1 year after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start8 Oct 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiang Long, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Long Jiang, MD, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307080
- Sponsor's protocol ID
- IIT2023-064
- Status last verified
- Jul 2025
- First submitted
- 18 Feb 2024
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Multimodal Ablation Remodeling Immunosensitized PD-1 in the Treatment of Pancreatic Cancer With Liver Metastasis
- ClinicalTrials.gov ID
- NCT06307080
- Acronym / sponsor ID
- IIT2023-064
- Conditions
- Pancreatic Cancer
- Keywords
- liver metastases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 8 Oct 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Clinical evaluation of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies.
- Construction of a combined treatment system of multimodal ablation therapy combined with immunotherapy and chemotherapy.
- Transformation and clinical application of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-mode thermal ablation combined with intravenous anti-PD-1 and chemotherapy | Experimental | Device: Multi-mode thermal ablation device, Drug: Intravenous anti-PD-1 and chemotherapyMultimodal ablation therapy +PD-1 antibody combined with intravenous chemotherapy was performed (carreilizumab 200 mg IV D1+ gemcitabine 1000mg/㎡ IV+ albumin binding paclitaxel 125mg/㎡ IV D1.8Q3W; For 6 weeks) |
| Intravenous anti-PD-1 and chemotherapy | Active comparator | Drug: Intravenous anti-PD-1 and chemotherapyIntravenous chemotherapy was performed (carreilizumab 200 mg IV D1+ gemcitabine 1000mg/㎡ IV+ albumin binding paclitaxel 125mg/㎡ IV D1.8Q3W; For 6 weeks) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18-70 years old, gender is not limited;
- Newly diagnosed pancreatic cancer with liver metastasis confirmed by pathology or consistent with clinical diagnosis, and no metastases to organs other than the liver;
- Imaging evaluable tumors with safe access to puncture;
- The number of half liver tumors ≤3 and the size of each tumor ≤3 cm;
- ECOG PS score ≤2 points, expected survival > 3 months.
Key exclusion criteria (8 listed)
- Liver function Child-Pugh grade C, severe jaundice, especially obstructive jaundice;
- The liver is significantly atrophy, the tumor is too large, and the ablation range needs to reach one-third of the liver volume;
- Expected survival < 3 months;
- serious heart, lung, liver and kidney dysfunction and coagulation dysfunction;
- Uncontrolled co-morbidities, including poorly controlled hypertension or diabetes, persistent active infections, or mental illness or social conditions that may affect participants' compliance with the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-mode thermal ablation deviceThe tumor tissue was rapidly frozen until the ice ball exceeded 5mm of the lesion tissue, kept for 5 minutes, then thawed and warmed. Then, complete ablation was performed according to the radiofrequency temperature control mode of multimodal tumor therapy to ensure that the ablation area included a safe range of 5~10mm around the tumor. | Device | Multi-mode thermal ablation combined with intravenous anti-PD-1 and chemotherapy |
| Intravenous anti-PD-1 and chemotherapyintravenous anti-PD-1 and chemotherapy | Drug | Intravenous anti-PD-1 and chemotherapy, Multi-mode thermal ablation combined with intravenous anti-PD-1 and chemotherapy |
Primary outcome
Safety and efficacy assessment
Time frame: Up to 1 year after the treatment
To evaluate the safety and efficacy of multimodal ablation therapy combined with immunotherapy
1 secondary outcome
Survival benefit
Time frame: Up to 1 year after the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Long Jiang, MD principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-mode thermal ablation device and Intravenous anti-PD-1 and chemotherapy in people with Pancreatic Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Long Jiang, MD (18017317460, jiang.long@shgh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and efficacy assessment (time frame: Up to 1 year after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.