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Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC

ConditionLocally Advanced Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRenovoRx

About this trial

The study is a multi-center, open-label, randomized active controlled study of subjects with locally advanced pancreatic adenocarcinoma which is unresectable.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or Cytopathology confirmed pancreatic adenocarcinoma with initial diagnosis within 8 weeks of consent for patients who enroll at cycle 1, and from the start of cycle 1 of gemcitabine + nab-paclitaxel chemotherapy for patients who enroll at cycle 2

Locally advanced, unresectable disease at screening and prior to randomization, as defined by NCCN criteria determined by an on-site, experienced, multidisciplinary team (as confirmed by CT or MRI within 30 days of the start of cycle 1)

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1

Age ≥ 18 years

Disqualifiers

Any prior treatment for pancreatic cancer OR more than one cycle of gemcitabine and nab-paclitaxel treatment. For subjects who have started on their first cycle of gemcitabine and nab-paclitaxel treatment prior to consent, Inclusion Criterion #1 only applies to the first gemcitabine and nab-paclitaxel dose and must be within 6 weeks of confirmed diagnosis

Any evidence of metastatic disease or another active malignancy within the past one year except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.

Subjects unable or unwilling to have their first randomized treatment within 3 weeks of the post induction imaging and within 5 weeks of their last induction treatment

Subjects without baseline tumor imaging

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gemcitabine

    Drug

    Chemotherapy

  • nab-paclitaxel

    Drug

    Chemotherapy

  • RenovoCath

    Device

    Intra-arterial catheter

Treatment groups

190 Participants
are divided into 2 treatment groups
Group A: IA TherapyExperimental treatment 2 interventions
Group B: IV TherapyActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Overall Survival

OS from time of randomization will be calculated using the Kaplan-Meier method and compared between the test and control groups using the stratified Wilcoxin Test

Time frame
Up to Five Years

Secondary outcomes

1

Overall Survival for treatment received and unresected populations

The primary endpoint analysis will be repeated for the Treatment Received and Unresected Subject populations.

Time frame
Up to Five Years
2

Progression Free Survival

To compare the Progression Free Survival of intra-arterial delivery of gemcitabine using the RenovoCath™ device vs. continuation of IV gemcitabine and nab-paclitaxel following induction therapy with gemcitabine and nab-paclitaxel and radiation treatment for locally advanced pancreatic adenocarcinoma. Disease response and progression will be assessed according to RECIST 1.1.

Time frame
Up to Five Years
3

Objective response rate and duration of response

Objective response is defined as a complete response, CR, or partial response, PR, determined by Investigator assessment and confirmed by repeat assessment ≥ 4 weeks after initial documentation.

Time frame
Up to Five Years
4

Health Related Quality of Life

The EORTC questionnaire will be used to assess health related quality of life. The summary scores for the EORTC questionnaire will be calculated at baseline and follow-up.

Time frame
Up to Five Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenovoRx

Lead sponsor

Source ClinicalTrials.gov
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