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Trial · NCT07028424

PANORAMIX : Optimizing 1st-line NALIRIFOX and Exploring Microbiota's Role in 2nd Line Pancreatic Cancer Treatment

NCT07028424, Phase 2, Not yet recruiting, GERCOR - Multidisciplinary Oncology Cooperative Group

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. PANORAMIX : Optimizing 1st-line NALIRIFOX and Exploring Microbiota's Role in 2nd Line Pancreatic Cancer Treatment. Trials, record NCT07028424. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07028424

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
PANORAMIX : Optimizing 1st-line NALIRIFOX and Exploring Microbiota's Role in 2nd Line Pancreatic Cancer Treatment
NCT number
NCT07028424
Status
Not yet recruiting
Phases
Phase 2
Enrollment
206 participants, estimated
Lead sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions
PDAC - Pancreatic Ductal Adenocarcinoma
Interventions
Nal-IRI, Ciprofloxacin, Paclitaxel, Gemcitabine, Oxaliplatin, Leucovorin, 5-Fluorouracil, Placebo
First posted
2025-06-19
Last updated
2025-07-01

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primary6-month progression-free survival (PFS) rate post randomization Step 1 (R1) in Arm 1A6 monthsTo assess the efficacy of a 6-month PFS rate post R1 in patients with metastatic PDAC who received first-line (L1) NALIRIFOX with LV5FU2 (5-FU/leucovorin) maintenance strategy during Step 1 (Arm 1A).
SecondaryProgression-free survival first-line (PFS-L1) post randomization Step 1 (R1) in Arm 1A and in Arm 1Bup to 5 yearsTo assess PFS-L1 post R1 in Arm 1A and Arm 1B
SecondaryProgression-free survival (PFS) post NALIRIFOX reintroduction (PFS-reintro) in Arm 1Aup to 5 yearsTo assess PFS-reintro in Arm 1A
SecondaryOverall survival post randomization Step 1 (OS-R1) in Arm 1A and in Arm 1Bup to 5 yearsTo assess OS-R1 in Arm 1A and Arm 1B
SecondaryOverall response rate of first-line (ORR-L1) at 4 months in Arm 1A and in Arm 1B4 monthsTo assess ORR-L1 at 4 months in Arm 1A and Arm 1B, according to RECIST 1.1
SecondaryOverall response rate post NALIRIFOX reintroduction (ORR-RI) in Arm 1Aup to 5 yearsTo assess ORR-RI in Arm 1A
SecondaryBest response rate of first-line (BRR-L1) in Arm 1A and in Arm 1Bup to 5 yearsTo assess BRR-L1 in Arm 1A and Arm 1B
SecondaryBest response rate of first-line after reintroduction of NALIRIFOX (BRR-L1R) in Arm 1Aup to 5 yearsTo assess BRR-L1R in Arm 1A
SecondaryDuration of disease control (DDC) in Arm 1A and in Arm 1Bup to 5 yearsTo assess DDC in Arm 1A and in Arm 1B
SecondaryGrade 3-4 adverse events (AEs)/serious AEs (SAEs) related to treatmentuntil 28 days after end of treatment visitTo assess safety (only grade 3-4 AEs/SAEs related to treatment in Arm 1A and Arm 1B, according to the NCI CTCAE v5.0

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07028424

GET https://conductscience.org/api/trials/v1/NCT07028424/registered