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New treatment option for Pancreatic Cancer Metastatic
Official title Polymeric Micellar Paclitaxel for Metastatic Pancreatic Cancer
ClinicalTrials.gov ID: NCT06752811
What this study is testing
What is paclitaxel polymeric micelles for injection?
paclitaxel polymeric micelles for injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreatic cancer metastatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 4）Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- 5）Survival is expected to be at least 3 months.
You likely can't join if
- 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...
- 3）CNS (central nervous system) or meningeal metastases are known, except for those with single brain metastases that are strictly controlled and...
- 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...
- 5） Human Immunodeficiency Virus test is positive.
- 6）Patients with active, uncontrolled bacterial, viral, or fungal infection requiring current systemic anti-infective therapy.
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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.
- 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...
- 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...
- 5） Human Immunodeficiency Virus test is positive.
- 6）Patients with active, uncontrolled bacterial, viral, or fungal infection requiring current systemic anti-infective therapy.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
- Shanghai, Shanghai Municipality, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.