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

NCT07806110 | Active Not Recruiting Phase 2

• 1 other identifier: MA-PC-II-019
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreas Ductal Adenocarcinoma

Keywords

Irinotecan Liposome ,AGN ,pancratic ductal adenocarcinoma,II phase

Outcome Measures

Primary Outcomes (1)

• R0 Resection Rate

  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).

  approximately 16 to 20 weeks post-enrollment

Secondary Outcomes (7)

• Resection Rate

  approximately 16 to 20 weeks post-enrollment

• pCR rate

  approximately 16 to 20 weeks post-enrollment

• EFS

  Up to 18 months

• OS

  Up to 36 months

• ORR

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

Study Arms (2)

cohort 1

EXPERIMENTAL

Neoadjuvant therapy: liposomal irinotecan injection (II) 60mg/m²+ nab-paclitaxel 125mg/m²+ gemcitabine 1000mg/m²+ SHR-1701 1800mg every 4-week cycle,during which radical surgery will be evaluated by the investigator.

Drug: SHR-1701; Drug: liposomal irinotecan+nab-paclitaxel+gemcitabine

cohort 2

EXPERIMENTAL

Irinosome Injection (II) combined with Albumin-Bound Paclitaxel and Gemcitabine

Drug: liposomal irinotecan+nab-paclitaxel+gemcitabine

Interventions

SHR-1701 DRUG

Neoadjuvant therapy: SHR-1701 1800mg every 4-week cycle

cohort 1

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.

cohort 1; cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, China

Location

MeSH Terms

Interventions

SHR-1701

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 8, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 8, 2026

Record last verified: 2026-07

Locations

CN (1)