Can a triple therapy outsmart pancreatic cancer?
NCT ID NCT06938282
First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether adding an experimental drug called HRS-4642 to standard immunotherapy and chemotherapy can help people with pancreatic cancer. The study includes adults with borderline resectable, locally advanced, or metastatic pancreatic cancer. Researchers will monitor side effects and measure how well the treatment shrinks tumors and improves survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-4642 combined with immunotherapy and chemotherapy
- What this could lead to
- If successful, this combination could offer a new treatment option for pancreatic cancer, potentially improving tumor shrinkage and survival rates.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not be conclusive. The combination may cause significant side effects and may not work for everyone.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Age: ≥18 years old, male or female; 2. Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by RECIST v1.1; 3. Arm 1 included patients with locally advanced or metastatic pancreatic cancer whose imaging assessment met the guideline definition, and Arm 2 included patients with borderline resectable pancreatic cancer whose imaging assessment met the guideline definition; 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; 5. Expected survival ≥ 6 months; 6. Adequate marrow and organ function; 7. Female participants of childbearing age must undergo a pregnancy test within one week before the start of the study medication, and the result is negative. They are willing to use a medically recognized and efficient contraceptive method during the study period and within three months after the last administration of the study medication; For male participants whose partners are women of childbearing age, they should agree to use effective methods of contraception during the study period and within 3 months after the last study administration; 8. Patients volunteered to participate in this study and signed informed consent. Exclusion Criteria: 1. Previously received any systemic therapy, including systemic chemotherapy, immunotherapy, targeted therapy, and anti-tumor Chinese medicine; 2. Known hypersensitivity to the study drug or any of its components; 3. Previous or concurrent other malignant tumors; 4. Participation in a clinical trial of any drug or medical device within 4 weeks prior to the first dose; 5. Live and attenuated vaccines were administered within 4 weeks prior to the first dose of study drug; 6. Previous allogeneic hematopoietic stem cell transplantation or organ transplantation; 7. Active CNS metastases (including CNS metastases with clinical symptoms, brain edema, CNS metastases that have been treated with or required steroid medications in the last 28 days, and CNS metastases that are new or have shown disease progression); 8. Symptomatic, advanced patients with visceral dissemination and short-term risk of life-threatening complications (including patients with uncontrolled large amounts of exudate \[thoracic, pericardial, peritoneal\]); if effusion is drained, those who have been stable for at least 2 weeks after drainage are eligible for enrollment (topical plasmapheresis is permitted on a routine basis prior to signing an informed consent form); 9. Patients with severe cardiovascular arterial thromboembolism (e.g., myocardial infarction, unstable angina, stroke), NYHA class 2 or greater cardiac insufficiency, and clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 10. Individuals with interstitial lung disease, non-infectious pneumonia or severe and uncontrolled medical illness, acute infections, recent history of major surgery (within 28 days or not yet recovered from side effects); 11. Individuals with congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (positive hepatitis B virus surface antigen \[HBsAg\] test result at screening along with a HBV-DNA test value of ≥10,000 copies/ml \[2000 IU/ml\]), active hepatitis C (positive hepatitis C virus antibody \[HCV-Ab\] test result at screening), or a combination of hepatitis B and hepatitis B and HCV-RNA. Positive HCV-Ab \[HCV-Ab\] test result at screening stage (also HCV-RNA positive) or co-infection with Hepatitis B and Hepatitis C; 12. Patients with any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enterocolitis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, and hyperthyroidism; patients with asthma that has resolved completely in childhood and does not require any intervention in adulthood may be included; patients with asthma that requires medical intervention with bronchodilators may not be included); 13. Systemic therapy with corticosteroids (\>10 mg/day of prednisone or other equivalent hormone) or other immunosuppressive agents within 2 weeks prior to the first dose; inhaled or topical corticosteroids are allowed in the absence of active autoimmune disease, as well as adrenal hormone replacement therapy at doses of ≤ 10 mg/day of prednisone at efficacious doses; 14. Presence of clinically significant acute or chronic pancreatitis; patients at high risk for pancreatitis, e.g., serum amylase and/or lipase concentrations ≥3 times ULN; 15. Other situations that the researcher felt should not be included.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Zhongshan Hospital, Fudan University
RECRUITINGShanghai, Shanghai Municipality, 200032, China
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- Personalized drug matching put to the test in pancreatic cancer