NCT07238283

Brief Summary

This study is a randomized, open-label, multicenter Phase III clinical trial designed to evaluate the efficacy and safety of Irinotecan Hydrochloride Liposome Injection (II) combined with oxaliplatin and 5-FU/LV versus nab-paclitaxel combined with gemcitabine as first-line treatment for advanced pancreatic cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
662

participants targeted

Target at P75+ for phase_3

Timeline
32mo left

Started Dec 2025

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Dec 2025Dec 2028

First Submitted

Initial submission to the registry

November 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

December 2, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

December 9, 2025

Status Verified

October 1, 2025

Enrollment Period

2.8 years

First QC Date

November 14, 2025

Last Update Submit

December 2, 2025

Conditions

First-line Treatment of Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS)

    From study start until target OS events have occurred (approximately 18 months after last patient enrollment)

Secondary Outcomes (4)

  • Objective Response rate (ORR)

    up to 6 months following the date the last patient was randomized

  • Disease Control Rate

    up to 6 months following the date the last patient was randomized

  • Duration of Response

    up to 6 months following the date the last patient was randomized

  • Progression free survival (PFS)

    From the date of first dose of study drug until progressive disease (PD), death, whichever occurs first,assessed up to 18 months

Study Arms (2)

Treatment group A

EXPERIMENTAL

Irinotecan Hydrochloride Liposome Injection (II) in combination with oxaliplatin, 5-fluorouracil, calcium folinate

Drug: Irinotecan Hydrochloride Liposome Injection (II); Oxaliplatin; 5Fluorouracil; Calcium folinate

Treatment group B

ACTIVE COMPARATOR

nab-paclitaxel in combination with gemcitabine

Drug: nab-paclitaxel; gemcitabine

Interventions

nab-paclitaxel; gemcitabineDRUG

nab-paclitaxel in combination with gemcitabine

Treatment group B
Irinotecan Hydrochloride Liposome Injection (II); Oxaliplatin; 5Fluorouracil; Calcium folinateDRUG

Irinotecan Hydrochloride Liposome Injection (II) in combination with oxaliplatin, 5-fluorouracil, calcium folinate

Treatment group A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ECOG performance status 0 or 1
  • Histological or cytologically confirmed pancreatic cancer that has not been previously treated in the metastatic disease.
  • Life expectancy of greater than or equal to3 months.
  • At least one measurable lesion is present according to the efficacy evaluation criteria for pancreatic cancer (RECIST 1.1)
  • Able and willing to provide a written informed consent

You may not qualify if:

  • Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor;
  • Known history of central nervous system (CNS) metastases.
  • Severe infection (\> CTCAE grade 2), such as severe pneumonia, bacteremia, infection complications, etc. requiring inpatient treatment, occurred within four weeks before enrollment, and symptoms and signs of infection requiring intravenous antibiotic therapy (except for prophylactic antibiotics) occurred within two weeks before enrollment;
  • Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Patients with NYHA class 2 and above cardiac failure; (2) unstable angina; (3) myocardial infarction that occurred within 6 months; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Interventions

OxaliplatinFluorouracilLeucovorin130-nm albumin-bound paclitaxelGemcitabine

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesDeoxycytidineCytidinePyrimidine Nucleosides

Central Study Contacts

Zengquan Gu

CONTACT

0518-82342973zengquan.gu@hengrui.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 20, 2025

Study Start

December 2, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

December 9, 2025

Record last verified: 2025-10

Locations

CN(1)