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Active, not recruiting

NCT Number: NCT07806110

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Hospital of Jilin University

Changchun, Jilin, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Severe gastrointestinal dysfunction (e.g., GI bleeding, obstruction, Grade >2 inflammation, or Grade > 1 diarrhea);
  • 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);
  • Current interstitial lung disease (ILD) or pneumonitis;
  • Known peripheral neuropathy (CTCAE Grade ≥3);
  • Coagulation dysfunction, bleeding tendency, or current thrombolytic or full-dose anticoagulant therapy.
  • Uncontrolled clinical cardiovascular symptoms or diseases;
  • 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;
  • 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

Treatment and study plan

SHR-1701

Drug

Neoadjuvant therapy:

SHR-1701 1800mg every 4-week cycle

liposomal irinotecan+nab-paclitaxel+gemcitabine

Drug

Neoadjuvant therapy:

liposomal irinotecan injection (II) 60mg/m²+ nab-paclitaxel 125mg/m²+ gemcitabine 1000mg/m²+ every 4-week cycle,during which radical surgery will be evaluated by the investigator.

Primary outcomes

  1. R0 Resection Rate

    Time frame: approximately 16 to 20 weeks post-enrollment

    Percentage of participants who undergo radical surgical resection and achieve an R0 margin status (defined as microscopically negative surgical margins with no tumor cells at the resection edge, >1 mm margin clearance).

Secondary outcomes

  1. Resection Rate

    Time frame: approximately 16 to 20 weeks post-enrollment

    Percentage of participants who undergo surgical resection following neoadjuvant therapy.

  2. pCR rate

    Time frame: approximately 16 to 20 weeks post-enrollment

    Percentage of participants who achieve a pathological complete response (defined as the complete absence of active tumor cells in the resected surgical specimen including primary tumor and regional lymph nodes, i.e., ypT0yN0).

  3. EFS

    Time frame: Up to 18 months

    Event-Free Survival

  4. OS

    Time frame: Up to 36 months

    overall survive

  5. ORR

    Time frame: From enrollment to the end of neoadjuvant therapy (approximately 16 weeks)

    Objective Response Rate

  6. DCR

    Time frame: From enrollment to the completion of neoadjuvant therapy (approximately 16 weeks)

    Disease Control Rate

  7. safety

    Time frame: From baseline up to 30 days post-surgery or post-last dose

    Incidence, severity, and causality of adverse events (AEs), serious adverse events (SAEs), and clinical laboratory abnormalities assessed according to NCI-CTCAE v5.0.

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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