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.
Trial 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… Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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.
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 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.
- 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.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07806110
- Acronym / sponsor ID
- MA-PC-II-019
- Conditions
- Pancreas Ductal Adenocarcinoma
- Keywords
- Irinotecan Liposome ,AGN ,pancratic ductal adenocarcinoma,II phase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cohort 1 | Experimental | Drug: SHR-1701, Drug: liposomal irinotecan+nab-paclitaxel+gemcitabineNeoadjuvant 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. |
| cohort 2 | Experimental | Drug: liposomal irinotecan+nab-paclitaxel+gemcitabineIrinosome Injection (II) combined with Albumin-Bound Paclitaxel and Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-1701Neoadjuvant therapy: SHR-1701 1800mg every 4-week cycle | Drug | cohort 1 |
| liposomal irinotecan+nab-paclitaxel+gemcitabineNeoadjuvant 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. | Drug | cohort 1, cohort 2 |
Primary outcome
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).
7 secondary outcomes
Resection Rate
Time frame: approximately 16 to 20 weeks post-enrollment
pCR rate
Time frame: approximately 16 to 20 weeks post-enrollment
EFS
Time frame: Up to 18 months
OS
Time frame: Up to 36 months
ORR
Time frame: From enrollment to the end of neoadjuvant therapy (approximately 16 weeks)
DCR
Time frame: From enrollment to the completion of neoadjuvant therapy (approximately 16 weeks)
safety
Time frame: From baseline up to 30 days post-surgery or post-last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 Resection Rate (time frame: approximately 16 to 20 weeks post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.