Metastatic Pancreatic AdenocarcinomaPhase 2NCT07831330
Albumin-bound Paclitaxel (II) in Combination With Gemcitabine as First Line Therapy for Metastatic Pancreatic Cancer
A Phase 2 study testing Albumin-bound Paclitaxel (Ⅱ) + Gemcitabine in people with Metastatic Pancreatic Adenocarcinoma and Albumin-bound Paclitaxel (II), run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
This is a prospective, multicenter, open-label, single-arm study in participants with metastatic pancreatic adenocarcinoma who have not received any prior systemic anti-tumor therapy for advanced disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Pancreatic Adenocarcinoma, Albumin-bound Paclitaxel (II), Gemcitabine
- What is being tested?
- Albumin-bound Paclitaxel (Ⅱ) + Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2026to 30 Jun 2029
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Age 18-75 years; 2.Histopathologically or cytologically confirmed metastatic pancreatic adenocarcinoma ; 3.No prior systemic anti-tumor therapy (neoadjuvant/adjuvant chemotherapy is permitted, provided that the interval between completion of treatment and initiation of study treatment is >6 months); 4.At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; 5.ECOG performance status 0-2; 6.Expected survival time ≥ 3 months; 7.Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L, platelet count (PLT) ≥ 100×10⁹/L, hemoglobin (Hb) ≥ 90 g/L; 8.Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (if liver metastases are present, ≤ 5×ULN is permitted); total bilirubin ≤ 1.5×ULN; 9.Renal function: Serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance ≥ 60 mL/min (calculated by the Cockcroft-Gault formula); 10.Coagulation function: Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5×ULN; 11.Ability to understand the study, and voluntary participation with signed informed consent.
Who cannot join
- 1.Participants with a history of other malignancies within the past 5 years (with the exception of cured basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancers that have been adequately treated and considered cured); 2.Known allergy or intolerance to the study drug or its excipients; 3.Participation in any investigational drug or device therapy within 30 days prior to the first dose of study drug.
- 4.Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy, defined as persistent signs/symptoms related to infection that have not improved despite appropriate antibiotics, antiviral therapy, and/or other treatments.
- 5.Known active HIV infection (i.e., HIV1/2 antibody positive); untreated active HBV infection (defined as HBsAg/HBcAg positive with HBV-DNA copy number above the upper limit of normal at the local laboratory) and HCV infection (HCV antibody positive with HCV-RNA level above the upper limit of normal); 6.There was uncontrolled systemic disease within 6 months before the first administration, including cardiovascular diseases such as unstable angina, myocardial infarction, chronic congestive heart failure of Class II or above (NYHA criteria), severe unstable ventricular arrhythmia, and history of severe pericardial disease; uncontrolled hypertension (defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg despite standard antihypertensive therapy), or history of hypertensive crisis or hypertensive encephalopathy; uncontrolled diabetes mellitus (fasting blood glucose ≥10 mmol/L); gastrointestinal diseases of significant clinical importance, including gastrointestinal obstruction, gastrointestinal perforation, intra-abdominal abscess/infection, etc.; 7.Severe venous thromboembolic events, including deep vein thrombosis and pulmonary embolism, within 3 months prior to enrollment.
- 8.Uncontrolled pleural effusion, ascites, or pericardial effusion. 9.Peripheral sensory neuropathy or peripheral motor neuropathy of grade ≥2 (according to CTCAE V6.0).
- 10.Symptomatic brain metastases, leptomeningeal metastases, spinal cord tumor involvement, or spinal cord compression.
- 11.Pregnant or lactating women, and patients of childbearing potential who refuse to take appropriate contraceptive measures during the trial.
- 12.Patients judged by the investigator to be unsuitable for participation in this study.
About this study
Official title: Albumin-bound Paclitaxel (II) in Combination With Gemcitabine as First Line Therapy for Metastatic Pancreatic Cancer: A Multicenter, Single-Arm Study
This is a prospective, multicenter, open-label, single-arm study in participants with metastatic pancreatic adenocarcinoma who have not received any prior systemic anti-tumor therapy for advanced disease. To evaluate the efficacy and safety of albumin-bound paclitaxel (II) combined with gemcitabine for first-line treatment of metastatic pancreatic cancer.
- Conditions
- Metastatic Pancreatic Adenocarcinoma, Albumin-bound Paclitaxel (II), Gemcitabine, First-Line
- Being tested
- Albumin-bound Paclitaxel (Ⅱ) + Gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin-bound Paclitaxel (Ⅱ) + GemcitabineDrug
Albumin-bound Paclitaxel (Ⅱ) (125 mg/m², intravenous infusion, on days 1, 8, and 15) plus gemcitabine (1000 mg/m², intravenous infusion, on days 1, 8, and 15), every 4 weeks (Q4W). After 6 cycles, albumin-bound Paclitaxel (Ⅱ) (on days 1 and 15) plus gemcitabine (on days 1 and 15), every 4 weeks, until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| investigational arm | Experimental | Not described Receives: Drug: Albumin-bound Paclitaxel (Ⅱ) + Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate(ORR)
Measured: Every 8 weeks from time of first dose of study drug until completion of treatment for approximately 6 months.
Secondary outcomes (3)
Disease Control Rate (DCR)
Measured: Every 8 weeks from time of first dose of study drug until completion of treatment for approximately 6 months.
Progression-Free Survival (PFS)
Measured: The median time from first dose administration to tumor progression (per RECIST v1.1) or death in trial participants is expected to be 6 months.
Overall Survival (OS)
Measured: Overall survival (OS), defined as the time from first dose administration to death from any cause, is estimated to be 13 months in trial participants.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start5 Sep 2026 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuirong Jiang, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831330
- Sponsor's protocol ID
- CSPC-XBZ-PC-K01
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Albumin-bound Paclitaxel (II) in Combination With Gemcitabine as First Line Therapy for Metastatic Pancreatic Cancer: A Multicenter, Single-Arm Study
- ClinicalTrials.gov ID
- NCT07831330
- Acronym / sponsor ID
- CSPC-XBZ-PC-K01
- Conditions
- Metastatic Pancreatic Adenocarcinoma, Albumin-bound Paclitaxel (II), Gemcitabine, First-Line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 5 Sep 2026 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 21 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.
This is a prospective, multicenter, open-label, single-arm study in participants with metastatic pancreatic adenocarcinoma who have not received any prior systemic anti-tumor therapy for advanced disease. To evaluate the efficacy and safety of albumin-bound paclitaxel (II) combined with gemcitabine for first-line treatment of metastatic pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| investigational arm | Experimental | Drug: Albumin-bound Paclitaxel (Ⅱ) + Gemcitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Age 18-75 years; 2.Histopathologically or cytologically confirmed metastatic pancreatic adenocarcinoma ; 3.No prior systemic anti-tumor therapy (neoadjuvant/adjuvant chemotherapy is permitted, provided that the interval between completion of treatment and initiation of study treatment is >6 months); 4.At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; 5.ECOG performance status 0-2; 6.Expected survival time ≥ 3 months; 7.Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L, platelet count (PLT) ≥ 100×10⁹/L, hemoglobin (Hb) ≥ 90 g/L; 8.Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (if liver metastases are present, ≤ 5×ULN is permitted); total bilirubin ≤ 1.5×ULN; 9.Renal function: Serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance ≥ 60 mL/min (calculated by the Cockcroft-Gault formula); 10.Coagulation function: Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5×ULN; 11.Ability to understand the study, and voluntary participation with signed informed consent.
Key exclusion criteria (7 listed)
- 1.Participants with a history of other malignancies within the past 5 years (with the exception of cured basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancers that have been adequately treated and considered cured); 2.Known allergy or intolerance to the study drug or its excipients; 3.Participation in any investigational drug or device therapy within 30 days prior to the first dose of study drug.
- 4.Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy, defined as persistent signs/symptoms related to infection that have not improved despite appropriate antibiotics, antiviral therapy, and/or other treatments.
- 5.Known active HIV infection (i.e., HIV1/2 antibody positive); untreated active HBV infection (defined as HBsAg/HBcAg positive with HBV-DNA copy number above the upper limit of normal at the local laboratory) and HCV infection (HCV antibody positive with HCV-RNA level above the upper limit of normal); 6.There was uncontrolled systemic disease within 6 months before the first administration, including cardiovascular diseases such as unstable angina, myocardial infarction, chronic congestive heart failure of Class II or above (NYHA criteria), severe unstable ventricular arrhythmia, and history of severe pericardial disease; uncontrolled hypertension (defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg despite standard antihypertensive therapy), or history of hypertensive crisis or hypertensive encephalopathy; uncontrolled diabetes mellitus (fasting blood glucose ≥10 mmol/L); gastrointestinal diseases of significant clinical importance, including gastrointestinal obstruction, gastrointestinal perforation, intra-abdominal abscess/infection, etc.; 7.Severe venous thromboembolic events, including deep vein thrombosis and pulmonary embolism, within 3 months prior to enrollment.
- 8.Uncontrolled pleural effusion, ascites, or pericardial effusion. 9.Peripheral sensory neuropathy or peripheral motor neuropathy of grade ≥2 (according to CTCAE V6.0).
- 10.Symptomatic brain metastases, leptomeningeal metastases, spinal cord tumor involvement, or spinal cord compression.
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 |
|---|---|---|
| Albumin-bound Paclitaxel (Ⅱ) + GemcitabineAlbumin-bound Paclitaxel (Ⅱ) (125 mg/m², intravenous infusion, on days 1, 8, and 15) plus gemcitabine (1000 mg/m², intravenous infusion, on days 1, 8, and 15), every 4 weeks (Q4W). After 6 cycles, albumin-bound Paclitaxel (Ⅱ) (on days 1 and 15) plus gemcitabine (on days 1 and 15), every 4 weeks, until disease progression or unacceptable toxicity. | Drug | investigational arm |
Primary outcome
Objective Response Rate(ORR)
Time frame: Every 8 weeks from time of first dose of study drug until completion of treatment for approximately 6 months.
3 secondary outcomes
Disease Control Rate (DCR)
Time frame: Every 8 weeks from time of first dose of study drug until completion of treatment for approximately 6 months.
Progression-Free Survival (PFS)
Time frame: The median time from first dose administration to tumor progression (per RECIST v1.1) or death in trial participants is expected to be 6 months.
Overall Survival (OS)
Time frame: Overall survival (OS), defined as the time from first dose administration to death from any cause, is estimated to be 13 months in trial participants.
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 21 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Albumin-bound Paclitaxel (Ⅱ) + Gemcitabine in people with Metastatic Pancreatic Adenocarcinoma and Albumin-bound Paclitaxel (II), run by The First Affiliated Hospital with Nanjing Medical University.
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 1 inclusion and 7 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: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Objective Response Rate(ORR) (time frame: Every 8 weeks from time of first dose of study drug until completion of treatment for approximately 6 months.). 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 21 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.