Pancreatic Ductal AdenocarcinomaPhase 2NCT07745790
Safety and Efficacy of Multimodal Thermal Therapy (MTT) Combined With KRAS G12V mRNA Vaccine, S-1, and Sintilimab in Patients With Metastatic Pancreatic Cancer
A Phase 2 study testing Multimodal Thermal Therapy (MTT) System, KRAS G12V mRNA Vaccine and Sintilimab in people with Pancreatic Ductal Adenocarcinoma and Liver Neoplasms, run by Ruijin Hospital at 1 site in China.
Trial summary
This is a single-arm, single-center, exploratory clinical study. A total of 20 participants with metastatic pancreatic ductal adenocarcinoma (with liver or lung metastasis) who have experienced disease progression after or are intolerant to standard first-line chemotherapy (based on the AG regimen [Albumin-bound… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma, Liver Neoplasms, Lung Neoplasms
- What is being tested?
- Multimodal Thermal Therapy (MTT) System, KRAS G12V mRNA Vaccine and Sintilimab
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 13 Jul 2026to 31 Jul 2029
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years old with no restriction on gender.
- Patients with advanced pancreatic cancer or postoperative recurrent pancreatic cancer confirmed by histopathological or cytological examination.
- Tumor tissues are confirmed to carry KRAS G12V mutation via sequencing and bioinformatics analysis (valid test reports obtained within the previous 12 months and recognized by the investigator are acceptable). In the dose expansion phase, patients must harbor at least one HLA allele capable of effectively presenting the corresponding antigen, including HLA-A11:01, HLA-A03:01, HLA-A30:01, HLA-A68:01, HLA-C01:02, HLA-C03:03, and HLA-C03:04.
- Disease resistance or intolerance to prior AG-based chemotherapy regimens.
- Presence of liver metastasis or lung metastasis.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
- Child-Pugh score ≤ 7 points.
- Expected overall survival of at least 3 months.
Who cannot join
- Presence of diffuse hepatic or pulmonary metastases.
- Prior local treatment including radiofrequency ablation, microwave ablation, radiotherapy or other local therapies for metastatic lesions.
- Current participation in other interventional clinical studies and receiving investigational treatment.
- Diagnosis of any other malignant disease within 5 years prior to the first study drug administration (excluding radically treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or radically resected in situ carcinoma).
- Prior history of solid organ or hematopoietic stem cell transplantation.
- Any disease requiring systemic treatment with corticosteroids (prednisone or equivalent daily dose > 10 mg) or other immunosuppressive agents within 14 days prior to enrollment.
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- Previous or current diagnosis of brain metastases with incompletely controlled symptoms (i.e., persistent or aggravated symptoms, or requirement for adjusted symptomatic treatment to maintain symptom relief).
- Presence of uncontrolled active infection.
- Renal dysfunction defined as serum creatinine > 176.8 μmol/L or creatinine clearance < 30 mL/min.
- Uncorrectable coagulation abnormalities, including platelet count < 50×10⁹/L, prothrombin time > 18 seconds, or prothrombin activity < 40%, which cannot be corrected.
- History of esophagogastric variceal rupture without effective treatment via endoscopy, interventional therapy or surgery.
- Patients with psychiatric disorders in the acute episode stage.
- Women of childbearing potential who are pregnant, breastfeeding, or planning to become pregnant during the study treatment period or within 3 months after the end of study treatment.
- Prior systemic pharmacotherapy, radiotherapy or local hepatic treatment with an interval of < 1 month from the last systemic or local hepatic treatment to the first study drug administration.
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
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000
baiyong shen, +86 18817821319, shenby@shsmu.edu.cn
About this study
Official title: A Study of Multimodal Thermal Therapy (MTT) Combined With KRAS G12V mRNA Vaccine, S-1, and Sintilimab for Safety and Efficacy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma Who Have Disease Progression After or Are Intolerant to Standard First-Line Therapy
This is a single-arm, single-center, exploratory clinical study. A total of 20 participants with metastatic pancreatic ductal adenocarcinoma (with liver or lung metastasis) who have experienced disease progression after or are intolerant to standard first-line chemotherapy (based on the AG regimen [Albumin-bound Paclitaxel plus Gemcitabine]) will be enrolled.The study aims to evaluate the safety, efficacy, and underlying immunological mechanisms of Multimodal Thermal Therapy (MTT) combined with a KRAS G12V mRNA vaccine, S-1, and Sintilimab.
- Being tested
- Multimodal Thermal Therapy (MTT) System, KRAS G12V mRNA Vaccine, Sintilimab, S-1
- Keywords
- Multimodal Thermal Therapy, mRNA, Metastatic Pancreatic Cancer
- Medical subject headings
- Liver Neoplasms, Lung Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Thermal Therapy (MTT) SystemDevice
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.
KRAS G12V mRNA VaccineBiological
Administered via intramuscular injection at a dose of 1 mg. The first dose will be given 1 to 3 days after Multimodal Thermal Therapy (MTT). Subsequent doses will be administered every 3 weeks (Q3W) according to the study dosing schedule and clinical discretion.
SintilimabDrug
Administered via intravenous infusion at a dose of 200 mg on Day 1 (d1). Treatment will begin on 7 days after MTT and will be repeated every 3 weeks (Q3W) until disease progression or unacceptable toxicity.
S-1Drug
Only participants aged <80 years will receive oral S-1. Treatment starts on Day 7 after MTT at a dose of 40-60 mg twice daily (bid) on Days 1 to 14 (d1-14) of each cycle. Cycles are repeated every 3 weeks (Q3W) until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | MTT + KRAS G12V mRNA Vaccine + Sintilimab ± S-1 Participants will receive Multimodal Thermal Therapy (MTT) combined with KRAS G12V mRNA vaccine and sintilimab.
In addition, oral S-1 (tegafur/gimeracil/oteracil) will be administered to participants aged <80 years.
Participants aged ≥80 years will receive MTT + KRAS G12V mRNA vaccine + sintilimab without S-1. Receives: Device: Multimodal Thermal Therapy (MTT) System; Biological: KRAS G12V mRNA Vaccine; Drug: Sintilimab; Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events (CTCAE v6.0)
To assess the safety profile of the combination regimen (MTT + KRAS G12V mRNA vaccine + Sintilimab ± S-1) in patients with metastatic pancreatic cancer. Safety will be evaluated by recording the incidence, type, and maximum grade of adverse events (AEs) and serious adverse events (SAEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Measured: From the start of treatment up to 90 days after the last dose (or end of treatment).
Frequency of Dose Modifications and Treatment Discontinuations
To evaluate patient tolerability to the multimodal regimen. Tolerability is defined as the ability of participants to receive the full planned treatment. Specifically, it measures the proportion of participants requiring dose modifications, treatment delays, treatment interruptions, or permanent discontinuation of any component of the therapy (MTT, S-1 [for those <80 years], Sintilimab, or mRNA vaccine) due to adverse events.
Measured: From the start of treatment up to 90 days after the last dose (or end of treatment).
Secondary outcomes (2)
Progression-Free Survival (RECIST 1.1)
Time from the date of first study intervention to the date of radiographic disease progression per RECIST version 1.1, death from any cause, or the date of the last effective follow-up. Radiographic assessments will be performed every 1-2 months using contrast-enhanced abdominal MRI or CT imaging.
Measured: From the date of first study intervention until disease progression, death, or the last effective follow-up (up to approximately 24 months)
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.
Measured: up to approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start13 Jul 2026 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745790
- Sponsor's protocol ID
- PLP1-13114
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Multimodal Thermal Therapy (MTT) Combined With KRAS G12V mRNA Vaccine, S-1, and Sintilimab for Safety and Efficacy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma Who Have Disease Progression After or Are Intolerant to Standard First-Line Therapy
- ClinicalTrials.gov ID
- NCT07745790
- Acronym / sponsor ID
- PLP1-13114
- Keywords
- Multimodal Thermal Therapy, mRNA, Metastatic Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 13 Jul 2026 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 4 Aug 2026 (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.
This is a single-arm, single-center, exploratory clinical study. A total of 20 participants with metastatic pancreatic ductal adenocarcinoma (with liver or lung metastasis) who have experienced disease progression after or are intolerant to standard first-line chemotherapy (based on the AG regimen [Albumin-bound Paclitaxel plus Gemcitabine]) will be enrolled.The study aims to evaluate the safety, efficacy, and underlying immunological mechanisms of Multimodal Thermal Therapy (MTT) combined with a KRAS G12V mRNA vaccine, S-1, and Sintilimab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Multimodal Thermal Therapy (MTT) System, Biological: KRAS G12V mRNA Vaccine, Drug: Sintilimab, Drug: S-1MTT + KRAS G12V mRNA Vaccine + Sintilimab ± S-1 Participants will receive Multimodal Thermal Therapy (MTT) combined with KRAS G12V mRNA vaccine and sintilimab. In addition, oral S-1 (tegafur/gimeracil/oteracil) will be administered to participants aged <80 years. Participants aged ≥80 years will receive MTT + KRAS G12V mRNA vaccine + sintilimab without S-1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥ 18 years old with no restriction on gender.
- Patients with advanced pancreatic cancer or postoperative recurrent pancreatic cancer confirmed by histopathological or cytological examination.
- Tumor tissues are confirmed to carry KRAS G12V mutation via sequencing and bioinformatics analysis (valid test reports obtained within the previous 12 months and recognized by the investigator are acceptable). In the dose expansion phase, patients must harbor at least one HLA allele capable of effectively presenting the corresponding antigen, including HLA-A11:01, HLA-A03:01, HLA-A30:01, HLA-A68:01, HLA-C01:02, HLA-C03:03, and HLA-C03:04.
- Disease resistance or intolerance to prior AG-based chemotherapy regimens.
- Presence of liver metastasis or lung metastasis.
Key exclusion criteria (14 listed)
- Presence of diffuse hepatic or pulmonary metastases.
- Prior local treatment including radiofrequency ablation, microwave ablation, radiotherapy or other local therapies for metastatic lesions.
- Current participation in other interventional clinical studies and receiving investigational treatment.
- Diagnosis of any other malignant disease within 5 years prior to the first study drug administration (excluding radically treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or radically resected in situ carcinoma).
- Prior history of solid organ or hematopoietic stem cell transplantation.
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 |
|---|---|---|
| Multimodal Thermal Therapy (MTT) SystemThe 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. | Device | Treatment Group |
| KRAS G12V mRNA VaccineAdministered via intramuscular injection at a dose of 1 mg. The first dose will be given 1 to 3 days after Multimodal Thermal Therapy (MTT). Subsequent doses will be administered every 3 weeks (Q3W) according to the study dosing schedule and clinical discretion. | Biological | Treatment Group |
| SintilimabAdministered via intravenous infusion at a dose of 200 mg on Day 1 (d1). Treatment will begin on 7 days after MTT and will be repeated every 3 weeks (Q3W) until disease progression or unacceptable toxicity. | Drug | Treatment Group |
| S-1Only participants aged <80 years will receive oral S-1. Treatment starts on Day 7 after MTT at a dose of 40-60 mg twice daily (bid) on Days 1 to 14 (d1-14) of each cycle. Cycles are repeated every 3 weeks (Q3W) until disease progression or unacceptable toxicity. | Drug | Treatment Group |
Primary outcome
Incidence and Severity of Adverse Events (CTCAE v6.0)
Time frame: From the start of treatment up to 90 days after the last dose (or end of treatment).
To assess the safety profile of the combination regimen (MTT + KRAS G12V mRNA vaccine + Sintilimab ± S-1) in patients with metastatic pancreatic cancer. Safety will be evaluated by recording the incidence, type, and maximum grade of adverse events (AEs) and serious adverse events (SAEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Frequency of Dose Modifications and Treatment Discontinuations
Time frame: From the start of treatment up to 90 days after the last dose (or end of treatment).
To evaluate patient tolerability to the multimodal regimen. Tolerability is defined as the ability of participants to receive the full planned treatment. Specifically, it measures the proportion of participants requiring dose modifications, treatment delays, treatment interruptions, or permanent discontinuation of any component of the therapy (MTT, S-1 [for those <80 years], Sintilimab, or mRNA vaccine) due to adverse events.
2 secondary outcomes
Progression-Free Survival (RECIST 1.1)
Time frame: From the date of first study intervention until disease progression, death, or the last effective follow-up (up to approximately 24 months)
Overall Survival
Time frame: up to approximately 36 months
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 4 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Multimodal Thermal Therapy (MTT) System, KRAS G12V mRNA Vaccine and Sintilimab in people with Pancreatic Ductal Adenocarcinoma and Liver Neoplasms, run by Ruijin Hospital 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 8 inclusion and 14 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: opening soon, as of the sponsor's last update on 4 Aug 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 baiyong shen (+86 18817821319, shenby@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Adverse Events (CTCAE v6.0) (time frame: From the start of treatment up to 90 days after the last dose (or end of treatment).). The study lists 2 primary outcomes in all. 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 4 Aug 2026.