Pancreas Ductal AdenocarcinomaPhase 2NCT07806110

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 Phase 2 study testing SHR-1701 and liposomal irinotecan+nab-paclitaxel+gemcitabine in people with Pancreas Ductal Adenocarcinoma, run by The First Hospital of Jilin University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pancreas Ductal Adenocarcinoma
What is being tested?: SHR-1701 and liposomal irinotecan+nab-paclitaxel+gemcitabine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteChina
Study dates: 30 Jul 2026to 31 Dec 2028
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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);

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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

Trial locations and contacts

1 site in 1 country.

China1 site

The First Hospital of Jilin University
Changchun, Jilin

Other trials in China

About this study

Official 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.

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
Being tested: SHR-1701, liposomal irinotecan+nab-paclitaxel+gemcitabine
Keywords: Irinotecan Liposome ,AGN ,pancratic ductal adenocarcinoma,II phase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SHR-1701Drug
Neoadjuvant therapy:
SHR-1701 1800mg every 4-week cycle
liposomal irinotecan+nab-paclitaxel+gemcitabineDrug
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.

Study groups in NCT07806110
Study group	Role	What they receive
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. Receives: Drug: SHR-1701; Drug: liposomal irinotecan+nab-paclitaxel+gemcitabine
cohort 2	Experimental	Irinosome Injection (II) combined with Albumin-Bound Paclitaxel and Gemcitabine Receives: Drug: liposomal irinotecan+nab-paclitaxel+gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: approximately 16 to 20 weeks post-enrollment

Secondary outcomes (7)

Resection Rate
Percentage of participants who undergo surgical resection following neoadjuvant therapy.
Measured: approximately 16 to 20 weeks post-enrollment
pCR rate
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).
Measured: approximately 16 to 20 weeks post-enrollment
EFS
Event-Free Survival
Measured: Up to 18 months
OS
overall survive
Measured: Up to 36 months
ORR
Objective Response Rate
Measured: From enrollment to the end of neoadjuvant therapy (approximately 16 weeks)
DCR
Disease Control Rate
Measured: From enrollment to the completion of neoadjuvant therapy (approximately 16 weeks)
safety
Incidence, severity, and causality of adverse events (AEs), serious adverse events (SAEs), and clinical laboratory abnormalities assessed according to NCI-CTCAE v5.0.
Measured: From baseline up to 30 days post-surgery or post-last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 202631 Dec 2028

First posted8 Sep 2026
Study start30 Jul 2026
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pancreas Ductal AdenocarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 62 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07806110
Sponsor's protocol ID: MA-PC-II-019
Status last verified: Jul 2026
First submitted: 2 Sep 2026
Last updated: 8 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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