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Can a Heat-and-Freeze treatment plus a vaccine outsmart pancreatic cancer?

NCT ID NCT07745790

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This phase 2 trial is testing a novel combination for people with metastatic pancreatic cancer that has progressed after standard first-line chemotherapy. The approach combines a device that alternately freezes and heats the tumor (multimodal thermal therapy) with a personalized mRNA vaccine targeting the KRAS G12V mutation, the chemotherapy drug S-1, and the immunotherapy sintilimab. The study aims to see if this combination is safe, tolerable, and potentially effective in slowing the disease, while also exploring how it affects the immune system.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A combination of multimodal thermal therapy (a device that freezes then heats the tumor), a KRAS G12V mRNA vaccine, the chemotherapy drug S-1, and the immunotherapy drug sintilimab.
What this could lead to
If successful, this approach could offer a new treatment option for people with advanced pancreatic cancer who have run out of standard options, potentially slowing tumor growth and extending life.
What could go wrong
This is an early, small trial (20 people) focused on safety and feasibility. The combination may cause significant side effects, and it's unknown whether it will effectively control the cancer in a larger group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200000, China

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