New cocktail of drugs shows promise for tough pancreatic cancer
NCT ID NCT06951997
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing a combination of five drugs (iparomlimab, tuvonralimab, chidamide, nab-paclitaxel, and gemcitabine) as a first treatment for people with metastatic pancreatic cancer. The study aims to see if this mix can shrink tumors and improve survival. It will enroll 33 participants and is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- iparomlimab, tuvonralimab, chidamide, albumin-bound paclitaxel, gemcitabine
- What this could lead to
- If successful, this could lead to a new first-line treatment option for metastatic pancreatic cancer, potentially improving response rates and survival.
- What could go wrong
- This is a small, early-phase trial with only 33 participants, so results may not apply to everyone. The drug combination may cause significant side effects and may not prove more effective than existing treatments.
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 33 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Dec 2027
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 to 75 years
- 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: * Understand and voluntarily sign the informed consent form for this study * Age ≥18 years and ≤ 75 years, ale or Female * Histologically or cytologically confirmed diagnosis of pancreatic cancer (originating from the pancreatic ductal epithelium), with clinical records showing metastatic pancreatic cancer (stage IV according to the AJCC 8th edition TNM staging of pancreatic cancer) * No prior anti-tumor treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.) received * At least one measurable lesion on imaging according to RECIST 1.1 * ECOG score 0-1 * Expected survival time ≥3 months * Adequate organ function, subjects must meet the following laboratory criteria:Platelet count ≥90x10\^9/L,White blood cell count ≥ 3.5 × 10⁹/L,Absolute neutrophil count (ANC) ≥1.5x10\^9/L,Hemoglobin \> 90g/L,Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN,Total bilirubin ≤ 1.5 ULN,Urea/Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN (and creatinine clearance rate (CCr) ≥ 50 mL/min),Left ventricular ejection fraction (LVEF) ≥ 50%,QTcF interval (Fridericia correction) \< 470 ms * Fertile women/non-sterilized men must use effective contraception Exclusion Criteria: * Inability to comply with the study protocol or procedures * patients with pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic follicular cell carcinoma, pancreatoblastoma, and solid-pseudopapillary tumors * Known presence of germline BRCA1/2 mutations * patients with known central nervous system metastases * Hypersensitivity or allergic predisposition to the study drug or its excipients * Concurrent use of any other investigational drug or participation in another clinical trial involving investigational therapy within 4 weeks * Major surgery, severe traumatic injury, fractures, or ulcers within 6 weeks before study * History of gastrointestinal perforation or fistula within 6 months before the first dose. Subjects may be enrolled if the perforation/fistula has been surgically repaired and the investigator confirms resolution * Clinically significant gastrointestinal disorders, including obstruction (including partial), dysphagia, malabsorption syndrome, or uncontrolled nausea, vomiting, diarrhea, or other conditions severely affecting nutrient absorption * Clinically significant bleeding or clear bleeding tendency within 1 month before the first dose, e.g.,gastrointestinal bleeding, hemorrhagic gastric ulcer * Any of the following concurrent conditions:(1) Uncontrolled hypertension, coronary artery disease, arrhythmia, or heart failure(2) Severe uncontrolled concurrent infection causing disability(3) Proteinuria ≥ 2+ (≥1.0 g/24 h)(4) Bleeding tendency or history within 2 months before enrollment, regardless of severity(5) Arterial/venous thromboembolic events within 12 months before treatment (e.g., cerebrovascular accident, transient ischemic attack)(6) Acute myocardial infarction, acute coronary syndrome, or CABG within 6 months before treatment(7) Unhealed fractures or chronic wounds(8) Coagulopathy, bleeding tendency, or ongoing anticoagulation therapy * History of other malignancies within 5 years before enrollment, except for adequately treated basal/squamous cell skin cancer or cervical carcinoma in situ * Any cardiovascular or cerebrovascular disease or risk factors * Active autoimmune disease or history of autoimmune disease within 4 weeks before enrollment * Prior allogeneic bone marrow or solid organ transplantation * Unresolved toxicities (\> CTCAE v5.0 Grade 1) from prior anticancer therapy, except alopecia, lymphopenia, and oxaliplatin-induced neurotoxicity (≤ Grade 2) * Prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1/CTLA-4 antibodies), immune checkpoint agonists (e.g., anti-ICOS/CD40/CD137/GITR/OX40 antibodies), or immune cell therapy (e.g., CAR-T) * Systemic treatment with corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressants within 14 days before the first dose * Known interstitial lung disease (ILD) or non-infectious pneumonitis (either symptomatic or requiring systemic steroids) * Any other clinically significant condition, metabolic disorder, physical/lab abnormality, epilepsy requiring treatment etal * Pregnant or breastfeeding women * Any other condition deemed unsuitable for study participation by the investigator
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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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Tianjin Medical University Cancer Institute and Hospital
RECRUITINGTianjin, China
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Other studies related to the condition(s) this trial covers.
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- Can removing liver tumors alongside the whipple procedure extend life in stage IV pancreatic cancer?
- Can a One-Two punch of radiation and immunotherapy tame pancreatic cancer?
- Can a Two-Drug immune attack shrink Hard-to-Treat pancreatic tumors?
- Can a targeted antibody give pancreatic cancer chemo a boost?