Pancreatic Cancer MetastaticPhase 3pompomNCT06752811
Polymeric Micellar Paclitaxel for Metastatic Pancreatic Cancer
A Phase 3 study testing paclitaxel polymeric micelles for injection, Gemcitabine Hydrochloride for Injection and Paclitaxel for Injection (albumin bound ) in people with Pancreatic Cancer Metastatic, run by Shanghai Yizhong Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
This trial is a multi-center, randomized, open, parallel-group and positive-controlled phase III trial to evaluate the efficacy and safety of paclitaxel polymeric micelles for injection plus gemcitabine as first-line treatment of metastatic pancreatic cancer compared with nab-Paclitaxel plus gemcitabine. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer Metastatic
- What is being tested?
- paclitaxel polymeric micelles for injection, Gemcitabine Hydrochloride for Injection and Paclitaxel for Injection (albumin bound )
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 2 sitesChina
- Study dates
- 5 Feb 2025to 31 Dec 2027
- Phase
- Phase 3
- 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) Men or women aged 18 to 75 years old (including the critical value).
- 2）Metastatic pancreatic cancer confirmed by histology or cytology.
- 3）Patients who have not previously received any systemic therapy (including chemotherapy, targeted, and immunotherapy), radiotherapy, surgery, or investigational drugs for the treatment of metastatic pancreatic cancer; Patients who have previously received neoadjuvant or adjuvant chemotherapy could be enrolled if the interval between last treatment and recurrence and metastasis is more than 6 months.
- 4）Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- 5）Survival is expected to be at least 3 months.
- 6）At least one metastatic lesion (non-lymph node lesions with a major diameter of ≥ 10 mm on CT or MRI and lymph node lesions with a minor diameter of ≥ 15 mm) that is measurable according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) and is amenable to accurate repeated measurement. Suspected metastatic lesions (non-regional lymph nodes) that do not meet the above measurable standards and the primary lesions are measurable, the metastatic lesions are confirmed pathologically, can also be included.
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- 7）The major organs function well: a) white blood cell count ≥ 3.0 × 10^9/L. b) Hemoglobin ≥ 90.0 g/L. c) Absolute neutrophil count ≥1.5 × 10^9/L. d) Platelet count ≥100 × 10^9/L. e) Total bilirubin ≤1.5 × upper limit of normal range (ULN). f) Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ 2.5 × ULN; For patients with liver metastasis, ALT, AST and ALP ≤ 5 × ULN; ALP ≤ 10 × ULN in patients with bone metastases.
- Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance estimated by Cockcroft Gault formula ≥50 ml/min.
- International normalized ratio (INR) ≤ 1.5 × ULN and prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- 8）Women of childbearing age are required to have a negative pregnancy test at the screening period and to use a highly effective contraceptive method for 6 months from the screening period to the last dose. Male participants whose partners are women of childbearing age are required to use a highly effective contraceptive method for 6 months after the first dose of a trial product until the last dose.
- 9）Patients are able to understand the steps of this trial, are willing to follow the clinical trial protocol to complete the trial, and sign the Informed Consent Form.
Who cannot join
- 1）Patients who are allergic to the investigational drugs and their analogues, or excipients.
- 2）Patients who had any other malignant tumors within 5 years before or at present, except those who had been completely cured, such as basal cell carcinoma, skin squamous cell carcinoma, melanoma in situ, papillary thyroid carcinoma and cervical carcinoma in situ, were excluded.
- 3）CNS (central nervous system) or meningeal metastases are known, except for those with single brain metastases that are strictly controlled and asymptomatic.
- 4）Patients with tumor liver metastasis exceeding 1/2 of the entire liver during screening; or there may be active hepatitis B (HBsAg test positive, HBV-DNA>500 IU/ml or research center detection limit [only when the research center limit is above 500 IU/ml]); Active hepatitis C (positive for hepatitis C virus (HCV) antibodies and HCV-RNA > research center detection limit).
- 5） Human Immunodeficiency Virus test is positive.
- 6）Patients with active, uncontrolled bacterial, viral, or fungal infection requiring current systemic anti-infective therapy.
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- 7） Patients who have a history of drug or alcohol abuse prior to screening.
- 8）Patients with severe organic lesions or major organ failure, such as decompensated heart and lung failure, leading to intolerance to chemotherapy.
- 9） Patients with bleeding tendency (e.g., presence of active ulcer lesions in stomach, melena and/or hematemesis within 3 months, hemoptysis).
- 10） History of severe cardiovascular and cerebrovascular diseases, including but not limited to:
- NYHA (New York Heart Association) class III or IV heart disease;
- Uncontrollable hypertension (i.e. systolic blood pressure ≥ 160 mmHg, and/or diastolic blood pressure ≥ 100 mmHg)；
- Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc;
- QT interval prolongation corrected for heart rate (corrected for QTc interval using Fridericia formula, males>450ms, females>470ms);
- Individuals with significant abnormalities in electrocardiogram with clinical significance;
- Acute coronary syndrome, congestive heart failure, stroke, or other grade 3 or higher cardiovascular events occurring within 6 months prior to the first administration;
- 11） Clinically uncontrollable third space effusion, such as pleural effusion, pericardial effusion, peritoneal effusion, etc. If there were no clinical symptoms, small amounts of pleural effusion or ascites that did not require clinical intervention could be enrolled only after strict control.
- 12） serious psychiatric disorders in the past or current.
- 13）Organ transplant recipients.
- 14）Use of the prohibited medications specified in the protocol is planned during the screening and treatment periods.
- 15） Patients with a history of psychotropic drug abuse and unable to quit.
- 16）Before screening, participants have participated in another clinical trial with an investigational nonbiologic agent (administered within the past 30 days or five half-lives, whichever was longer) or an investigational biologic agent (monoclonal or polyclonal antibody) (within the past 4 months or five half-lives, whichever is longer).
- 17）Pregnant or lactating female patients.
- 18）Participants who are judged by the investigator to be unable to follow trial procedures or who are judged by the investigator to be unfit to participate in the trial for other reasons.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Min Tu, +86 13585181045, tumin1215@163.com
Kui Rong Jiang
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201400
Si Shi, +86181 2129 9331, shisi@fudanpci.org
Xianjun Yu
About this study
Official title: A Multi-center, Randomized, Open, Parallel-group, Positive Drug-controlled Phase III Clinical Trial for Evaluating the Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection Plus Gemcitabine and Paclitaxel for Injection (Albumin-bound) Plus Gemcitabine for Injection in the First-line Treatment of Metastatic Pancreatic Cancer
This trial is a multi-center, randomized, open, parallel-group and positive-controlled phase III trial to evaluate the efficacy and safety of paclitaxel polymeric micelles for injection plus gemcitabine as first-line treatment of metastatic pancreatic cancer compared with nab-Paclitaxel plus gemcitabine.
Read the detailed description
Based on the widespread use of paclitaxel in pancreatic cancer, this study aims to develop a clinical protocol of paclitaxel polymeric micelles for injection in combination with gemcitabine as first-line treatment for metastatic pancreatic cancer, in order to find a more effective treatment option for pancreatic patients and thus improve survival outcomes.
- Conditions
- Pancreatic Cancer Metastatic
- Being tested
- paclitaxel polymeric micelles for injection, Gemcitabine Hydrochloride for Injection, Paclitaxel for Injection (albumin bound )
- Keywords
- paclitaxel polymeric micelles for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel polymeric micelles for injectionDrug
Paclitaxel polymeric micelles for injection at a dose of 300 mg/m2 (based on body surface area), administered on Day 1, with intravenous infusion for ≥ 3 hours, every 3 weeks as a cycle.
Gemcitabine Hydrochloride for InjectionDrug
The subjects also need to receive intravenous infusion of gemcitabine hydrochloride combination therapy at a dose of 1000 mg/m2 (based on body surface area), administered at D1 and D8 every 3 weeks.
Paclitaxel for Injection (albumin bound )Drug
Patients in the control group will receive intravenous infusion of paclitaxel for Injection (albumin bound ) at a dose of 125 mg/m2 (based on body surface area), administered at D1, D8, and D15, every 4 weeks as a cycle.
Gemcitabine Hydrochloride for InjectionDrug
The subjects also need to receive intravenous infusion of gemcitabine hydrochloride combination therapy at a dose of 1000 mg/m2 (based on body surface area), administered at D1, D8, and D15 every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| paclitaxel polymeric micelles for injection+Gemcitabine Hydrochloride for Injection | Experimental | Patients in the experimental group will receive intravenous infusion of paclitaxel polymeric micelles for injection at a dose of 300 mg/m2 (based on body surface area), administered on Day 1, with intravenous infusion for ≥ 3 hours, every 3 weeks as a cycle. Then, the subjects also need to receive intravenous infusion of gemcitabine hydrochloride combination therapy at a dose of 1000 mg/m2 (based on body surface area), administered at D1 and D8 every 3 weeks. Receives: Drug: paclitaxel polymeric micelles for injection; Drug: Gemcitabine Hydrochloride for Injection |
| paclitaxel for injection(albumin bound )+Gemcitabine Hydrochloride for Injection | Active comparator | Control Group: Patients in the control group will receive intravenous infusion of paclitaxel (albumin bound) at a dose of 125 mg/m2 (based on body surface area), administered at D1, D8, and D15, every 4 weeks as a cycle. Then, the subjects also need to receive intravenous infusion of gemcitabine hydrochloride combination therapy at a dose of 1000 mg/m2 (based on body surface area), administered at D1, D8, and D15 every 4 weeks. Receives: Drug: Paclitaxel for Injection (albumin bound ); Drug: Gemcitabine Hydrochloride for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free-Survival
PFS(Progression-Free-Survival) is the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurs first.
Measured: Randomization to measured PD or date of death from any cause（up to 36 months)
Secondary outcomes (4)
Overall Survival(OS)
The time from randomization to death.
Measured: Randomization to date of death from any cause（up to 36 months)
Objective Response Rate(ORR)
Proportion of subjects who have achieved complete response (CR) or partial response (PR) (RECIST 1.1)
Measured: Baseline to measured PD（up to 36 months)
Disease Control Rate（DCR）
Proportion of subjects who have achieved complete response (CR), partial response (PR) or stable disease (SD) (RECIST 1.1)
Measured: Baseline to measured PD（up to 36 months)
Incidence of adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0".
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start5 Feb 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer MetastaticStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yizhong Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752811
- Sponsor's protocol ID
- Shanghai Yizhong
- Acronym
- pompom
- Status last verified
- May 2025
- First submitted
- 20 Dec 2024
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Open, Parallel-group, Positive Drug-controlled Phase III Clinical Trial for Evaluating the Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection Plus Gemcitabine and Paclitaxel for Injection (Albumin-bound) Plus Gemcitabine for Injection in the First-line Treatment of Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06752811
- Acronym / sponsor ID
- pompom / Shanghai Yizhong
- Conditions
- Pancreatic Cancer Metastatic
- Keywords
- paclitaxel polymeric micelles for injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Shanghai Yizhong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Dec 2024 (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 trial is a multi-center, randomized, open, parallel-group and positive-controlled phase III trial to evaluate the efficacy and safety of paclitaxel polymeric micelles for injection plus gemcitabine as first-line treatment of metastatic pancreatic cancer compared with nab-Paclitaxel plus gemcitabine.
Detailed description
Based on the widespread use of paclitaxel in pancreatic cancer, this study aims to develop a clinical protocol of paclitaxel polymeric micelles for injection in combination with gemcitabine as first-line treatment for metastatic pancreatic cancer, in order to find a more effective treatment option for pancreatic patients and thus improve survival outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paclitaxel polymeric micelles for injection+Gemcitabine Hydrochloride for Injection | Experimental | Drug: paclitaxel polymeric micelles for injection, Drug: Gemcitabine Hydrochloride for InjectionPatients in the experimental group will receive intravenous infusion of paclitaxel polymeric micelles for injection at a dose of 300 mg/m2 (based on body surface area), administered on Day 1, with intravenous infusion for ≥ 3 hours, every 3 weeks as a cycle. Then, the subjects also need to receive intravenous infusion of gemcitabine hydrochloride combination therapy at a dose of 1000 mg/m2 (based on body surface area), administered at D1 and D8 every 3 weeks. |
| paclitaxel for injection(albumin bound )+Gemcitabine Hydrochloride for Injection | Active comparator | Drug: Paclitaxel for Injection (albumin bound ), Drug: Gemcitabine Hydrochloride for InjectionControl Group: Patients in the control group will receive intravenous infusion of paclitaxel (albumin bound) at a dose of 125 mg/m2 (based on body surface area), administered at D1, D8, and D15, every 4 weeks as a cycle. Then, the subjects also need to receive intravenous infusion of gemcitabine hydrochloride combination therapy at a dose of 1000 mg/m2 (based on body surface area), administered at D1, D8, and D15 every 4 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1) Men or women aged 18 to 75 years old (including the critical value).
- 2）Metastatic pancreatic cancer confirmed by histology or cytology.
- 3）Patients who have not previously received any systemic therapy (including chemotherapy, targeted, and immunotherapy), radiotherapy, surgery, or investigational drugs for the treatment of metastatic pancreatic cancer; Patients who have previously received neoadjuvant or adjuvant chemotherapy could be enrolled if the interval between last treatment and recurrence and metastasis is more than 6 months.
- 4）Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- 5）Survival is expected to be at least 3 months.
Key exclusion criteria (24 listed)
- 1）Patients who are allergic to the investigational drugs and their analogues, or excipients.
- 2）Patients who had any other malignant tumors within 5 years before or at present, except those who had been completely cured, such as basal cell carcinoma, skin squamous cell carcinoma, melanoma in situ, papillary thyroid carcinoma and cervical carcinoma in situ, were excluded.
- 3）CNS (central nervous system) or meningeal metastases are known, except for those with single brain metastases that are strictly controlled and asymptomatic.
- 4）Patients with tumor liver metastasis exceeding 1/2 of the entire liver during screening; or there may be active hepatitis B (HBsAg test positive, HBV-DNA>500 IU/ml or research center detection limit [only when the research center limit is above 500 IU/ml]); Active hepatitis C (positive for hepatitis C virus (HCV) antibodies and HCV-RNA > research center detection limit).
- 5） Human Immunodeficiency Virus test is positive.
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 |
|---|---|---|
| paclitaxel polymeric micelles for injectionPaclitaxel polymeric micelles for injection at a dose of 300 mg/m2 (based on body surface area), administered on Day 1, with intravenous infusion for ≥ 3 hours, every 3 weeks as a cycle. | Drug | paclitaxel polymeric micelles for injection+Gemcitabine Hydrochloride for Injection |
| Gemcitabine Hydrochloride for InjectionThe subjects also need to receive intravenous infusion of gemcitabine hydrochloride combination therapy at a dose of 1000 mg/m2 (based on body surface area), administered at D1 and D8 every 3 weeks. | Drug | paclitaxel polymeric micelles for injection+Gemcitabine Hydrochloride for Injection |
| Paclitaxel for Injection (albumin bound )Patients in the control group will receive intravenous infusion of paclitaxel for Injection (albumin bound ) at a dose of 125 mg/m2 (based on body surface area), administered at D1, D8, and D15, every 4 weeks as a cycle. | Drug | paclitaxel for injection(albumin bound )+Gemcitabine Hydrochloride for Injection |
| Gemcitabine Hydrochloride for InjectionThe subjects also need to receive intravenous infusion of gemcitabine hydrochloride combination therapy at a dose of 1000 mg/m2 (based on body surface area), administered at D1, D8, and D15 every 4 weeks. | Drug | paclitaxel for injection(albumin bound )+Gemcitabine Hydrochloride for Injection |
Primary outcome
Progression-Free-Survival
Time frame: Randomization to measured PD or date of death from any cause（up to 36 months)
PFS(Progression-Free-Survival) is the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurs first.
4 secondary outcomes
Overall Survival(OS)
Time frame: Randomization to date of death from any cause（up to 36 months)
Objective Response Rate(ORR)
Time frame: Baseline to measured PD（up to 36 months)
Disease Control Rate（DCR）
Time frame: Baseline to measured PD（up to 36 months)
Incidence of adverse events
Time frame: up to 36 months
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 10 Feb 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing paclitaxel polymeric micelles for injection, Gemcitabine Hydrochloride for Injection and Paclitaxel for Injection (albumin bound ) in people with Pancreatic Cancer Metastatic, run by Shanghai Yizhong Pharmaceutical Co., Ltd. at 2 sites 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 11 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Xiao ya Wang (+86 15601735965, 15601735965@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free-Survival (time frame: Randomization to measured PD or date of death from any cause（up to 36 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 10 Feb 2026.