New chemo cocktail targets pancreatic cancer at every stage
NCT ID NCT07828756
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Researchers are testing a chemotherapy combination built around albumin-bound paclitaxel (II) for people with pancreatic cancer. The study has three groups: one for advanced cancer that cannot be removed by surgery, one for cancer that may be removable and receives treatment before surgery, and one for cancer that has been removed and receives treatment after surgery. The goal is to see how well the combination controls the cancer and how safe it is.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- albumin-bound paclitaxel (II) combined with cisplatin, capecitabine, and gemcitabine
- What this could lead to
- If the combination works, it could offer doctors more options for treating pancreatic cancer at different stages, from before surgery to after it.
- What could go wrong
- This is a Phase 2 exploratory study with 147 participants, so it cannot prove the regimen is better than standard care. Pancreatic cancer is hard to treat, and combining several chemotherapy drugs may cause significant side effects.
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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 147 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2030
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: * Aged 18 to 75 years old. * Histopathologically confirmed pancreatic adenocarcinoma meeting any one of the following conditions: (1) Unresectable locally advanced or metastatic pancreatic cancer, with no prior systemic anti-tumor therapy for advanced disease. Prior neoadjuvant/adjuvant chemotherapy is permitted, provided the interval from completion of prior chemotherapy to study drug administration is more than 6 months. (2) High-risk resectable or borderline resectable pancreatic cancer assessed by a multidisciplinary team.(3) Curative resection (R0 or R1 resection) performed without prior neoadjuvant therapy, and adjuvant treatment can be initiated within 12 weeks postoperatively. * Presence of at least one measurable lesion per RECIST v1.1 (exclusive to participants in Cohort 3). * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Estimated survival time ≥ 3 months. * Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 1.5×10⁹/L, platelet count (PLT) ≥ 100×10⁹/L, hemoglobin (Hb) ≥ 90 g/L. * Adequate liver function: alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5×ULN (≤5×ULN allowed in patients with liver metastases); total bilirubin ≤ 1.5×ULN. * Adequate renal function: serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance ≥ 60 mL/min (calculated by Cockroft-Gault formula). * Adequate coagulation function: prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5×ULN. * Women of childbearing potential must have a negative serum/urine pregnancy test within 14 days prior to enrollment, be non-lactating, and agree to use effective contraception throughout the study and for 6 months after the last study treatment. Male participants must agree to effective contraception during the study and for 6 months after study completion. * Able to understand the study information; participant or legal representative voluntarily provides written informed consent. Exclusion Criteria: * History of other malignant tumors within the past 5 years * Known hypersensitivity or intolerance to any study drug or excipients. * Confirmed homozygous or compound heterozygous DPYD variants leading to complete dihydropyrimidine dehydrogenase (DPD) deficiency. * Presence of any of the following comorbidities: ① Severe or uncontrolled cardiovascular disease: New York Heart Association (NYHA) Class II or higher chronic heart failure, uncontrolled hypertension (systolic BP \>150 mmHg and/or diastolic BP \>90 mmHg despite stable medication), etc. ② Severe respiratory disorders: asthma requiring inhaled/systemic glucocorticoids, active chronic obstructive pulmonary disease, etc. ③ Confirmed neurological diseases (epilepsy, dementia, etc.) or Grade ≥2 peripheral sensory/motor neuropathy. ④ Uncontrolled diabetes mellitus (fasting blood glucose ≥10 mmol/L under stable treatment). ⑤ Severe chronic or active infections requiring ≥1 consecutive week of systemic antibacterial, antifungal or antiviral therapy (including tuberculosis). ⑥ Active HIV infection (HIV antibody positive); untreated active HBV (HBsAg/HBcAg positive with HBV-DNA above institutional upper limit of normal) or active HCV infection (HCV antibody positive with HCV-RNA above institutional upper limit of normal). * Untreated active brain metastases (including symptomatic brain or leptomeningeal metastases). Participants with brain metastases are eligible only if brain lesions are stable on imaging performed ≥4 weeks prior to first study dose, no new neurological symptoms or baseline symptom relapse, and no systemic steroid administration for ≥14 days before study treatment initiation, with no evidence of new or enlarged metastatic lesions. * Medical history as follows: ① Major abdominal/thoracic surgery within 28 days prior to first study dose, or planned major surgery during the study period (diagnostic puncture and infusion port implantation excluded). ② Severe cardiovascular/cerebrovascular events (myocardial infarction, unstable angina, cerebrovascular accident) within 6 months prior to enrollment; clinically silent lacunar infarcts are permitted. * History of deep vein thrombosis or pulmonary embolism within 3 months prior to enrollment. * Inability to swallow or untreated malabsorption syndrome. * Receipt of any investigational product within 1 month prior to enrollment. * Any other condition judged by the investigator to render the participant unsuitable for study participation.
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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 & Hospital
Tianjin, China
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Other studies related to the condition(s) this trial covers.
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- New drug candidate takes aim at Hard-to-Treat pancreatic cancer