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Immunotherapy cocktail takes on tough pancreatic cancer

NCT ID NCT06050317

Disease control Sponsor: Shandong Cancer Hospital and Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial is testing whether adding the immunotherapy drug sintilimab to chemotherapy and radiation can help people with inoperable pancreatic cancer live longer. The study will enroll 25 participants who have not had prior treatment. Researchers will track how long the cancer stays under control and any side effects.

What this could mean

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

Active substance
Sintilimab (an immunotherapy drug) plus chemotherapy (mFFN or NALIRIFOX) and radiation
What this could lead to
If it works, this could offer a new treatment option to control inoperable pancreatic cancer and extend survival.
What could go wrong
This is a small, early-phase trial with only 25 people, so results may not apply widely. Side effects from the combination therapy could be significant.

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 25 people

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

Started

Aug 2023

Expected to finish

Aug 2026

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 to 75 years

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: * ECOG PS 0-1 * Pathological tissue-confirmed unresectable locally advanced pancreatic cancer * Pancreatic cancer patients who have not received systemic anti-tumor therapy * Primary pancreatic cancer or at least one measurable lesion specified by RECIST1.1 standards * A life expectancy of \> 3 months * Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.0 ×109 cells/L, platelets ≥ 75×109 cells/L, hemoglobin ≥ 9.0 g/dl * AST\<2.5 × ULN(Upper Limit of Normal), ALT\<2.5 × ULN,creatinine ≤1.5xULN, total bilirubin \< ≤1.5 X ULN. Exclusion Criteria: * Diagnosed with other malignant diseases other than pancreatic cancer within three years before enrollment * Patients who are currently participating in interventional clinical research treatment or have received other research drugs or used research devices within four weeks before enrollment * Patients who have previously received anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T-cell receptors * Patients who have received systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects within two weeks before enrollment * Abnormal results of blood routine examinations and liver and kidney and coagulation tests * Abnormal function of major organs (14 days before enrollment) * Women who are pregnant * Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.

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Conditions

The condition(s) this trial relates to.

malignant pancreatic neoplasm pancreatic neoplasm

As listed by the trial registrant

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

Pancreas cancer

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

  • Department of Radiation Oncology, Shandong Cancer Hospital and Institute

    RECRUITING

    Jinan, Shandong, 0531, China

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