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Pancreatic Cancer Non-resectablePhase 2NCT05047991

Study of Irinotecan Liposome Injection-containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

A Phase 2 study testing Irinotecan Liposome Injection, Fluorouracil and Leucovorin in people with Pancreatic Cancer Non-resectable and Pancreatic Cancer Metastatic, run by CSPC Ouyi Pharmaceutical Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a multicenter, randomized, open-lable, parallel-controlled phase II study of irinotecan liposome injection-containing regimens versus nab-paclitaxel plus gemcitabine in patients with previously untreated, metastatic pancreatic adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Irinotecan Liposome Injection, Fluorouracil and Leucovorin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
No sites listed yet
Study dates
Oct 2021to Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 70 years old (inclusive), regardless of gender;
  • Histologically or cytologically confirmed unresectable, locally advanced, or metastatic pancreatic adenocarcinoma;
  • At least one measurable lesion according to RECIST 1.1.
  • No prior systemic anti-tumor therapy, except those with disease progression more than 6 months after adjuvant therapy or neoadjuvant therapy;
  • Patients with prior local treatment (radical radiotherapy or radical chemoradiotherapy, etc.) may be enrolled provided that the local treatment does not involve the target lesion, or the target lesion is within the treatment area, but the size has increased more than 20% since the post-treatment evaluation, and also must be completed at least 4 weeks before the first administration of the study drug, palliative decompensated radiotherapy (such as bone metastases) must be completed at least 2 weeks before the first administration of the study drug;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
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  • Life expectancy >3 months;
  • Adverse reactions must recover to grade 1 or baseline according to CTCAE 5.0 (except for toxicity such as alopecia, grade 2 or less sensory neuropathy, etc., which have been judged no safety risk by investigators).
  • Patients should not receive cell growth factors or blood and platelet transfusion within 7 days before the initiate administration of study drug, and laboratory test must meet the following criteria:
  • neutrophile count ≥1.5×10^9/L; platelet count ≥100×10^9/L; hemoglobin ≥90 g/L or ≥5.6 mmol/L; serum creatinine ≤1×ULN or creatinine clearance rate must be ≥ 50 mL/min when serum creatinine >1.0×ULN; total bilirubin ≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN or ≤5×ULN if intrahepatic lesions exist; Albumin ≥3 g/dL.
  • Activated Partial Thromboplastin Time (APTT), International Normalized Ratio (INR) and prothrombin time (PT) ≤1.5 × ULN for patients not receiving therapeutic anticoagulation.
  • According to the related guidelines, patients with HBV DNA or HBsAg and/or anti-HBC positive must receive prophylactic treatment (at least one week before the initial administration of the study drug) and take antiviral drugs in stable dose (e.g., entecavir, tenofovir, or lamivudine; No adefovir or interferon are allowed) at study entry with planned monitoring and management, including baseline HBV DNA levels. Patient receiving active hepatitis C virus (HCV) treatment must use astable dose of drugs at study entry and be subject to planned monitoring and management according to antiviral drug guidelines;
  • Female patients with reproductive potential must agree to use adequate contraception from the signing of informed consent to at least 6 months after the study completion and have a negative serum pregnancy test within 3 days before enrollment, and must be non-lactating. Male patients must agree to use medically approved contraception during the study period and for 6 months after the study completion;
  • Ability to understand and the willingness to sign a written informed consent.

Who cannot join

  • Patients with acinar cell carcinoma, pancreatoblastoma, solid pseudopapillary tumor and pancreatic neuroendocrine tumor;
  • Patients with definitive diagnosis of CNS metastasis;
  • Patients with hepatic encephalopathy at screening;
  • Patients with clinically symptomatic ascites requiring puncture or drainage or who have received ascites drainage within the past 3 months, except for those with only a small amount of ascites on imaging but no clinical symptoms;
  • Uncontrolled third lacunar effusion other than ascites (e.g., large pleural or pericardial effusion) within 4 weeks before the first administration of the test drug;
  • Previous malignancies in the past five years (except radically resected and non-recurring basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, local prostate carcinoma, carcinoma in situ of cervical, or other carcinoma in situ);
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  • Patients with partial or complete biliary obstruction who has not relieved by active treatment;
  • History of serious cardiovascular disease, including but not limited to:
  • 1) Acute myocardial infarction, unstable angina pectoris, coronary angioplasty, stroke, severe pulmonary embolism; 2) New York Heart Association class grade III or IV congestive heart failure or left ventricular ejection fraction (LVEF) < 50%; 3) Poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure≥ 95 mmHg) with optimal treatment; 4) Ventricular arrhythmia; 5) Patients with prolonged QT/QTc interval in baseline electrocardiogram (ECG) (QTcF > 480 ms, Fridericia formula: QTcF = QT/(RR^0.33), RR = 60/heart rate); 6) Patients with clinically significant abnormal electrocardiogram (ECG) according to the investigator's assessment.
  • 9.Patients with uncontrolled active bleeding.
  • 10.Patients with known interstitial lung disease;
  • 11.Patients with known peripheral neuropathy (CTCAE grade 3 or 4);
  • 12.Patients with severe lung, liver, kidney, endocrine, immune system, skin or musculoskeletal diseases within 3 months prior to the first dose and who are not suitable for enrollment in the opinion of the investigator;
  • 13.Patients who are at risk of active infection or have active infection that may affect the results of the study (such as severe pneumonia requiring hospitalization, bacteremia, acute bacterial infection, infectious complications, tuberculosis, active HIV infection, etc.) or who, in the judgment of the investigator, are not suitable for participation in this clinical trial. Active hepatitis B virus is defined as HBV DNA≥10^4 copies or ≥ 2000 IU/mL; active hepatitis C virus or active HIV infection is defined as HCV-RNA positive;
  • 14.Gastrointestinal diseases of clinical significance, such as bleeding, inflammation, obstruction, >grade 1 diarrhea, malabsorption syndrome, diseases significantly affecting gastrointestinal function, gastric or small bowel resection, etc;
  • 15.Patients with known to have dihydropyrimidine dehydrogenase (low activity) or deficiency;
  • 16.Patients with definite Gilbert syndrome;
  • 17.History of explicit neurological or psychiatric disorders, including epilepsy or dementia;
  • 18.Patients with known alcohol or drug dependence.
  • 19.Patients who have concomitant use of strong CYP3A4 inducers within 2 weeks prior to the first dose, or strong CYP3A4 inhibitors or strong UGT1A1 inhibitors within 1 week prior to the first dose;
  • 20.Patients who have required systemic glucocorticoids (prednisone >10 mg/day or equivalent dose of the similar drugs) or other immunosuppressive agents within 14 days before the first dose of the study drug. Except for treatment with local, ocular, intra-articular, intranasal, and inhaled glucocorticoids in the absence of active autoimmune disease, short-term preventive treatment with glucocorticoids (e.g., prevention of contrast allergy);
  • 21.Patients who have major organ surgery (except for needle biopsy, central venous catheterization, port-cath, stenting to relieve biliary obstruction, and percutaneous hepatic biliary drainage, cholecystostomy) or selective operation plan were performed within 4 weeks before the first dose of the study drug;
  • 22.Patients with known allergy to irinotecan liposome injection, other liposome products, oxaliplatin, 5-fluorouracil, leucovorin, Nab-paclitaxel, other albumin products, gemcitabine or any of the ingredients in the above products.;
  • 23. Patients who are not suitable for this study as determined by the investigator.

Trial locations and contacts

No sites are listed yet.

Jihui Hao, Ph.D contact

86-18622221120

haojihui@tjmuch.com

About this study

Official title: A Multicenter, Randomized, Open-lable, Parallel-controlled, Phase II Study to Evaluate the Differences of Safety and Efficacy of Irinotecan Liposome Injection-containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

This is a multicenter, randomized, open-lable, parallel-controlled phase II study of irinotecan liposome injection-containing regimens versus nab-paclitaxel plus gemcitabine in patients with previously untreated, metastatic pancreatic adenocarcinoma. The purpose of this study is to evaluate the differences of safety and efficacy of irinotecan liposome injection-containing regimens versus nab-paclitaxel plus gemcitabine in patients with previously untreated, metastatic pancreatic adenocarcinoma.

Read the detailed description

This is a multicentre randomized, open-label, parallel-controlled, phase II study to evaluate the efficacy and safety of irinotecan liposome injection-containing regimens. Eligible patients will be randomly divided into two cohorts at a ratio of 2:1. The patients in cohort 1 (the experimental group) will receive irinotecan liposome injection combined with 5-fluorouracil (5-FU), leucovorin (LV) and oxaliplatin.The patients in cohort 2 (the control group) will receive nab-paclitaxel plus gemcitabine.

Being tested
Irinotecan Liposome Injection, Fluorouracil, Leucovorin, Oxaliplatin, Nab paclitaxel

What participants receive

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

  • Irinotecan Liposome InjectionDrug

    Irinotecan Liposome Injection, intravenously, over 90 min on day 1and day 15 of every 28-day cycle

  • FluorouracilDrug

    5-Fluorouracil (5-Fu), intravenously, over 46 h on day 1 and day 15 of every 28-day cycle

  • LeucovorinDrug

    Leucovorin (LV), intravenously, over 30 min on day 1 and day 15 of every 28-day cycle

  • OxaliplatinDrug

    Oxaliplatin, intravenously, over 2 h on day 1 and day 15 of every 28-day cycle

  • Nab paclitaxelDrug

    Paclitaxel (albumin bound), intravenously, over 30 min on day 1, day 8 and day 15 of every 28-day cycle

  • GemcitabineDrug

    Gemcitabine, intravenously, over 30 min on day 1, day 8 and day 15 of every 28-day cycle

Study groups in NCT05047991
Study groupRoleWhat they receive
Cohort 1: Irinotecan Liposome Injection + 5-FU/LV + OxaliplatinExperimentalThe patients in cohort 1 will receive irinotecan liposome injection combined with 5-fluorouracil (5-FU), leucovorin(LV) and oxaliplatin intravenously on day 1 and day 15 of every 28-day cycle until disease progression or unacceptable toxicity, or termination of the study due to other reasons.
Receives: Drug: Irinotecan Liposome Injection; Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin
Cohort 2: Nab-paclitaxel + GemcitabineActive comparatorThe patients in cohort 2 will receive nab-paclitaxel and gemcitabine intravenously on day 1、day 8 and day 15 of every 28-day cycle until disease progression or unacceptable toxicity, or termination of the study due to other reasons.
Receives: Drug: Nab paclitaxel; Drug: Gemcitabine

What is being measured

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

  1. Progression-Free Survival (PFS)

    Time from date of the first dose to date of recorded disease progression or death, whichever occurs first.

    Measured: Up to twelve months after the last patient's first administration

Secondary outcomes (8)

  1. Objective Response Rate (ORR)

    The percentage of patients who achieve a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

    Measured: Up to twelve months after the last patient's first administration

  2. Overall survival (OS)

    Time from date of the first dose to date of death from any cause.

    Measured: Up to twelve months after the last patient's first administration

  3. Disease Control Rate (DCR)

    The percentage of patients who achieve a CR, PR or stable disease (SD) based on the RECIST 1.1.

    Measured: Up to twelve months after the last patient's first administration

  4. Duration of Response (DOR)

    Time from first documented response (CR or PR whichever occurs first, based on investigator's assessment per RECIST 1.1) to date of disease progression or death due to any cause, whichever occurs first.

    Measured: Up to twelve months after the last patient's first administration

  5. Incidence of treatment-related adverse events (AEs) and serious adverse events (SAEs)

    The AEs and SAEs will be assessed according to the National Cancer Institute (NCI) CTCAE v5.0.

    Measured: Up to twelve months after the last patient's first administration

  6. Peak Plasma Concentration

    Cmax

    Measured: Day 0 to Day 7 of circle 1

  7. Area under the plasma concentration versus time curve

    AUC

    Measured: Day 0 to Day 7 of circle 1

  8. UGT1A1

    UGT1A1 gene polymorphism

    Measured: Within 3 days before the first dose

Timeline

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

  1. First posted17 Sep 2021
  2. Study startOct 2021 (estimated)
  3. Primary completionNov 2023 (estimated)
  4. Study completionNov 2024 (estimated)

Resources

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
153 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05047991
Sponsor's protocol ID
HE072-CSP-004
Status last verified
Sep 2021
First submitted
26 Aug 2021
Last updated
17 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irinotecan Liposome Injection, Fluorouracil and Leucovorin in people with Pancreatic Cancer Non-resectable and Pancreatic Cancer Metastatic, run by CSPC Ouyi Pharmaceutical Co., Ltd..

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 14 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: status not confirmed, as of the sponsor's last update on 17 Sep 2021. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jihui Hao, Ph.D (86-18622221120, haojihui@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Up to twelve months after the last patient's first administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05047991.

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 17 Sep 2021.

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