NCT07806110Active, not recruitingPhase 2
Gemcitabine and Albumin-Bound Paclitaxel Combined With Liposomal Irenotecan (II) With or Without SHR-1701 as Neoadjuvant Therapy for Resectable or Borderline Resectable Pancreatic Cancer
A Prospective, Phase II Study of Gemcitabine and Nab-paclitaxel in Combination With Liposomal Irinotecan (II) With or Without SHR-1701 as Neoadjuvant Therapy for Resectable/Borderline Resectable Pancreatic Cancer.
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
Based on the superior efficacy and safety profile of liposomal irinotecan over irinotecan in pancreatic cancer, as well as preliminary results from earlier studies evaluating nab-paclitaxel and gemcitabine (AG) combined with liposomal irinotecan, this study aims to further evaluate the efficacy and safety of liposomal irinotecan plus AG as neoadjuvant therapy in patients with resectable or borderline resectable pancreatic cancer (RPC/BRPC). The ultimate goal is to identify a more effective treatment regimen to prolong overall survival in this patient population.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- First submitted
- 2 Sept 2026
- Start date
- 30 Jul 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- The First Hospital of Jilin University
- Diseases
- Pancreatic cancer
- NCT number
- NCT07806110
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 62
- From 30 Jul 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Symptomatic ascites requiring paracentesis or drainage, or patients who have received ascites drainage within the past 3 months (except for those with asymptomatic, controllable minimal ascites detected solely on imaging);
- Malignancy other than pancreatic cancer within 5 years prior to randomization, with the exception of adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin;
Other illness
- Severe gastrointestinal dysfunction (e.g., GI bleeding, obstruction, Grade \>2 inflammation, or Grade \> 1 diarrhea);
- Current interstitial lung disease (ILD) or pneumonitis;
- Coagulation dysfunction, bleeding tendency, or current thrombolytic or full-dose anticoagulant therapy.
- Uncontrolled clinical cardiovascular symptoms or diseases;
- Known hypersensitivity to liposomal irinotecan, other liposomal formulations, gemcitabine, nab-paclitaxel, retlirafusp alfa injection, or any component of these products;
- Known Acquired Immunodeficiency Syndrome (AIDS), positive HIV antibody test, or active syphilis infection;
- History of neurological or psychiatric disorders, including epilepsy or dementia
Other
- Patients with pancreatic tumors originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic acinar cell carcinoma, pancreatoblastoma, and solid-pseudopapillary neoplasm
- Known central nervous system (CNS) metastases
- Known peripheral neuropathy (CTCAE Grade ≥3);
Who the study is looking for
- Age ≥18 years, male or female;
- Resectable or borderline resectable pancreatic cancer
- No prior anti-tumor therapy (including radiotherapy, ablation, chemotherapy, targeted therapy, immunotherapy, etc.) or investigational drug treatment
- At least one measurable lesion as a target lesion according to RECIST v1.1 criteria
- ECOG performance status: 0-1
- Expected survival time ≥3 months
- Adequate major organ function
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.