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Peritoneal CarcinomatosisPhase 2Nab-PIPACNCT05371223

Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine Chemotherapy for Pancreatic Cancer Peritoneal Metastases

A Phase 2 study testing Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine in people with Peritoneal Carcinomatosis and Pancreas Neoplasm, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Combined chemotherapy consisting of endovenous Nabpaclitaxel-Gemcitabine and Nabpaclitaxel-PIPAC may be a promising treatment for patients affected by pancreatic cancer PM who are in need of curative options. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peritoneal Carcinomatosis, Pancreas Neoplasm
What is being tested?
Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteItaly
Study dates
1 Mar 2022to 30 Jul 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years;
  • Willing and able to provide written and informed consent;
  • Histological or cytological proof of pancreatic cancer;
  • Metastatic disease with peritoneal carcinomatosis determined by the treating physician, based on abdominal CT or MR and/or diagnostic laparotomy or laparoscopy;
  • Evaluable disease defined by RECIST 1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
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  • Life expectancy of at least 3 months;
  • No contraindication for laparoscopy;
  • No contraindication for drugs used in the study;
  • Adequate bone marrow function: Absolute neutrophil count ≥ 1500 cell./mm3; Platelets ≥ 100000 cell./mm3;
  • Hemoglobin ≥ 9 g/dl
  • Adequate renal function (serum creatinine up to 1.5 times the maximal limit of the local laboratory) or else based upon clinical evaluation;

Who cannot join

  • Advanced metastatic systemic disease with clinical deterioration;
  • Patients with extraabdominal tumor spread;
  • Patients with a germline or somatic pathogenic variant involving an (Homologous Recombination Repair) HRR-related gene;
  • Symptoms of gastrointestinal occlusion and total parenteral nutritional support;
  • Patients defined as "refractory" to previous systemic treatment with Nab-paclitaxel and Gemcitabine administered for locally advanced pancreatic cancer (patients treated with Nabpaclitaxel-Gemcitabine for a locally advanced disease may be included if PM developed after at least 6 months from the end of previous chemotherapy);
  • History of severe and unexpected reactions to Nabpaclitaxel or Gemcitabine derivates
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  • Known hypersensitivity reaction to drugs chemically related to Nabpaclitaxel, Gemcitabine and their excipients;
  • Severe cardiac disease (recent myocardial ischemia, severe cardiac arrhythmias, severe cardiac failure);
  • Clinical disease progression after first 2 months of systemic Nabpaclitaxel Gemcitabine chemotherapy;
  • Any concurrent severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk of associated with study participation or investigational product administration or may interfere with compliance with study procedures or the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into the study;

Trial locations and contacts

1 site in 1 country.

Andrea Di Giorgio, MD contact

+393288994872

andrea.digiorgio@policlinicogemelli.it

Italy1 site, 1 recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, 00168

    Andrea Di Giorgio, MD, +390630157255, andrea.digiorgio@policlinicogemelli.it

    Recruiting

Other trials in Italy

About this study

Official title: Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine Chemotherapy for Pancreatic Cancer Peritoneal Metastases - A Single-arm, Open-label, Phase II Trial: Nab-PIPAC Trial

Combined chemotherapy consisting of endovenous Nabpaclitaxel-Gemcitabine and Nabpaclitaxel-PIPAC may be a promising treatment for patients affected by pancreatic cancer PM who are in need of curative options.

The purpose of this study is to evaluate the antitumoral activity of combined Nabpaclitaxel-PIPAC and systemic Nabpaclitaxel-Gemcitabine chemotherapy for pancreatic cancer peritoneal metastases.

Read more

Secondary objectives include the evaluation of the feasibility, the safety, further assessment of the antitumoral activity, the overall and progression free survival, the QoL, the pharmacokinetics of Nabpaclitaxel PIPAC.

Furthermore, the study aims to evaluate the patients' nutritional status and the molecular evolution of PM along treatment with a time-course translational research.

Read the detailed description

Pancreatic carcinoma (PC) is an aggressive neoplasm carrying a high metastatic potential with a 5-year survival rate of 7%. The vast majority of cases already developed locally advanced disease, and distant metastases are present at the time of diagnosis. Furthermore, the recurrence rate is nearly 80% within the first two years after surgery, and about half of these patients show peritoneal relapse. Palliative systemic chemotherapy represents the standard treatment option in case of peritoneal metastases (PM) from PC but roughly reaches a median overall survival of 6-11 months with more than 5% of serious adverse events.

Based on the available data, Nabpaclitaxel is indicated in combination with Gemcitabine for the first-line systemic treatment of patients with metastatic adenocarcinoma of the pancreas.

Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) is a novel intraperitoneal drug-delivery system of low-dose chemotherapy as a pressurized aerosol. Until now, the combination cisplatin/doxorubicin or oxaliplatin has been administered by PIPAC. Recently, a phase I study (NCT03304210) was conducted to explore the use of intraperitoneal Nabpaclitaxel administered by PIPAC, confirming its safety and preliminary efficacy. The recommended dose to safely start a phase-II study was 112.5 mg/m2.

Being tested
Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine
Medical subject headings
Peritoneal Neoplasms, Pancreatic Neoplasms

What participants receive

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

  • Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-GemcitabineDrug

    Each combined course is constituted by two consecutive 28-day cycles of systemic chemotherapy (three adminstrations per cycle: days 1,8 and 15) and one cycle of PIPAC administered within 10-13 days from the last administration of systemic chemotherapy. Between each combined course a 7-10 days pause is observed.

    The recommended dose of Nabpaclitaxel in combination with Gemcitabine is 125 mg/m2 administered endovenous over 30 minutes on Days 1, 8 and 15 of each 28-day cycle. The concurrent recommended dose of Gemcitabine is 1000 mg/m2 administered intravenously over 30 minutes immediately after the completion of Nabpaclitaxel administration on Days 1, 8 and 15 of each 28-day cycle.

    A pressurized aerosol containing Nabpaclitaxel at the dose of 112,5 mg/m2 diluted in a total volume of 200 ml of NaCl 0.9% is applied through the nebulizer inside the abdominal cavity during laparoscopy.

Study groups in NCT05371223
Study groupRoleWhat they receive
InterventionalExperimentalEligible patients affected by pancreatic cancer PM will be enrolled according to in-/exclusion criteria. Each patient will be scheduled for three treatment combined courses for a total of six cycles of endovenous Nabpaclitaxel-Gemcitabine chemotherapy and three of Nabpaclitaxel-PIPAC.
Receives: Drug: Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine

What is being measured

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

  1. Disease Control Rate (DCR)

    The Disease Control Rate (DCR) defined as the combined incidence of complete response (CR), partial response (PR) and stable disease (SD) according to the RECIST v. 1.1 criteria during study treatments and the EOT visit.

    Measured: Three and a half years

Secondary outcomes (9)

  1. The compliance to treatment

    • The number of patients unable to undergo six cycles of systemic chemotherapy combined with three PIPAC cycles and reasons for discontinuation.

    Measured: Three and a half years

  2. Toxicity assessed by CTCAE

    • The number of patients with major toxicity, defined as grade ≥3 according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 during the on-study evaluation phase and up to 4 weeks after the last chemotherapy administration.
    • The number of patients with minor toxicity, defined as grade ≤2 according to CTCAE v5.0 during the treatment period and up to 4 weeks after the last chemotherapy administration.

    Measured: Three and a half years

  3. Postoperative complication assessed by Clavien-Dindo

    -The number of patients with major and minor postoperative complications, defined as grade ≥3 and grade ≤2 according to Clavien-Dindo, respectively, during the treatment period and up to 4 weeks after the last PIPAC procedure.

    Measured: Three and a half years

  4. Antitumoral activity assessed by PRGS

    -The pathological tumor response, based on the review of peritoneal biopsies collected during each PIPAC, performed by a pathologist blinded to clinical outcomes using the Peritoneal Regression Grading Score (PRGS). A patient will be considered a responder if any reduction in the PRGS during subsequent biopsies will be recorded;

    (PRGS 1: Complete regression without cancer cells - PRGS 2: higher response with prevalence of regressive phenomena and only a few residual cancer cells - PRGS 3: minor response with prevalence of residual cancer cells and poor regressive phenomena - PRGS 4: no response to therapy without regressive phenomena A reduction in the PRGS during subsequent biopsies will be considered as a positive response.)

    Measured: Three and a half years

  5. Antitumoral activity assessed by PCI

    -The macroscopic tumor response, based on Peritoneal Cancer Index (PCI) recorded during each PIPAC;

    The PCI index will be calculated according to the Sugarbaker method, which provides the assignment of a score between 0 and 3 based on the size of peritoneal metastases (0 without lesions; 1 if diam. 0.5 cm; 2 if diam. between 0.5 and 5 cm; 3 if diam > 5 cm or coalescent lesions) observed in 12 regions of the peritoneal cavity. The maximum score is 39.

    Measured: Three and a half years

  6. Antitumoral activity assessed by ascites volume

    • The macroscopic tumor response, based on ascites volume recorded during each PIPAC

    Measured: Three and a half years

  7. Antitumoral activity assessed by tumor markers

    • The biochemical tumor response, based on tumor markers (CEA, Ca 19.9, Ca 125) measured at different time points.

    Measured: Three and a half years

  8. The Progression Free Survival (PFS)

    the time between treatment start and one of the following events, whichever comes first:

    • radiologic progression based on RECIST criteria v. 1.1,
    • clinical progression (eg, bowel occlusion, inability to oral feeding, refractory ascites),
    • death;

    Measured: From treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

  9. The Overall Survival (OS)

    The Overall Survival (OS) is defined as the time between treatment start and death.

    Measured: From treatment start to death, assessed up to 12 months

Timeline

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

  1. First posted12 May 2022
  2. Study start1 Mar 2022
  3. Primary completion30 May 2025 (estimated)
  4. Study completion30 Jul 2025 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05371223
Sponsor's protocol ID
4368
Acronym
Nab-PIPAC
Status last verified
Feb 2024
First submitted
16 Mar 2022
Last updated
26 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Di Giorgio A, Ferracci F, Bagala C, Carbone C, Salvatore L, Strippoli A, Attalla El Halabieh M, Abatini C, Alfieri S, Pacelli F, Tortora G. Combined Nabpaclitaxel pressurized intraPeritoneal aerosol chemotherapy with systemic Nabpaclitaxel-Gemcitabine chemotherapy for pancreatic cancer peritoneal metastases: protocol of single-arm, open-label, phase II trial (Nab-PIPAC trial). Pleura Peritoneum. 2024 Nov 6;9(3):121-129. doi: 10.1515/pp-2024-0010. eCollection 2024 Sep.

    PubMed 39544430

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine in people with Peritoneal Carcinomatosis and Pancreas Neoplasm, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

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 12 inclusion and 10 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 26 Feb 2024. 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 Italy. 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?

Results are not available in the source record.

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

Contact Andrea Di Giorgio, MD (+393288994872, andrea.digiorgio@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Control Rate (DCR) (time frame: Three and a half years). 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 NCT05371223, which also lists 1 linked publication.

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 26 Feb 2024.

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