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Advanced Pancreatic CancerPhase 1NCT04796948

A Study of Irinotecan Liposome in Advanced Pancreatic Cancer

A Phase 1 study testing Irinotecan liposome；oxaliplatin；5-FU(Fluorouracil Injection)；LV(Calcium Folinate Injection) in people with Advanced Pancreatic Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine the safety and tolerability of irinotecan liposome in combination with oxaliplatin and 5-FU/LV in subjects with advanced pancreatic cancer who have not received prior systemic chemotherapy Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Pancreatic Cancer
What is being tested?
Irinotecan liposome；oxaliplatin；5-FU(Fluorouracil Injection)；LV(Calcium Folinate Injection)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteChina
Study dates
8 Apr 2021to 28 Jun 2024
Phase
Phase 1
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

  • Males and females aged 18 to 70 years (including 18 and 70 years);
  • Patients with histologically or cytologically diagnosed pancreatic cancer (from pancreatic ductal epithelium), and clinical records show unresectable locally advanced or metastatic pancreatic cancer (stage III/IV based on the 8th Edition of the AJCC TNM staging for pancreatic cancer).
  • Have not received systemic anti-tumor therapy for the current stage of disease, including surgery (except stent placement), radiotherapy, chemotherapy, targeted therapy, immunotherapy or investigational therapy;
  • If the subject has previously received adjuvant chemotherapy, it is necessary to ensure that the time interval between the last dose and the first dose of this study is more than 12 months, and the adjuvant therapy-toxicity has recovered (judged as ≤ grade 1 based on CTCAE 5.0 criteria);
  • Must have at least one measurable lesion that can be taken as the target lesion (according to the RECIST v1.1 criteria);
  • Eastern Cooperative Oncology Group (ECOG) performance status score: 0 - 1 point;
  • Expected survival ≥3 months;
  • Major organs are functioning well

Who cannot join

  • Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor;
  • Patients with known central nervous system metastases;
  • Patients carrying homozygous mutations of UGT1A1*28/*6 gene;
  • Severe gastrointestinal dysfunction;
  • 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;
  • Received any of the following treatments:
Show all 9Show fewer
  • 1）Previously received treatment with irinotecan-containing regimens; 2）Received concomitant medications containing strong inhibitors/strong inducers of CYP3A4 or strong inhibitors of UGT1A1 within two weeks before enrollment; 3）Received the last anti-cancer treatment (including surgery, radiotherapy, etc.) within four weeks before enrollment; 4）Have received treatment with any other investigational drug/device within four weeks before enrollment; 5）Enrolled in another clinical study at the same time unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up.
  • 7.Having experienced an arteriovenous thrombotic event, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism, within one year before enrollment; 8.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 one year; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
  • 9.Patients who have suffered from malignant tumors other than pancreatic cancer before using the study drug for the first time, except those with low risk of metastasis and death (5-year survival rate >90%), such as adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin; 10.Have any contraindication to either irinotecan liposome, irinotecan, 5-FU, calcium folinate, or oxaliplatin;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: A Phase I Study to Evaluate the Safety and Tolerability of Irinotecan Liposome in Combination With Oxaliplatin and 5-FU/LV in the Treatment of Advanced Pancreatic Cancer

To determine the safety and tolerability of irinotecan liposome in combination with oxaliplatin and 5-FU/LV in subjects with advanced pancreatic cancer who have not received prior systemic chemotherapy

Being tested
Irinotecan liposome；oxaliplatin；5-FU(Fluorouracil Injection)；LV(Calcium Folinate Injection)

What participants receive

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

  • Irinotecan liposome；oxaliplatin；5-FU(Fluorouracil Injection)；LV(Calcium Folinate Injection)Drug

    irinotecan liposome in combination with oxaliplatin and 5-FU/LV

Study groups in NCT04796948
Study groupRoleWhat they receive
Irinotecan liposome；oxaliplatin；5-FU(Fluorouracil Injection)；LV(Calcium Folinate Injection)Experimental1. irinotecan liposome: irinotecan liposome injection is irinotecan encapsulated in liposomes for i.v. infusion. 2. oxaliplatin: oxaliplatin is a sterile, aqueous solution; 50mg/vial. 3. 5-FU(Fluorouracil Injection): an aqueous, sterile, nonpyrogenic injectable solution available in 10ml/0.25g. 4. LV(Calcium Folinate Injection): be supplied in vials containing 10ml/0.1g and available as an injectable solution.
Receives: Drug: Irinotecan liposome；oxaliplatin；5-FU(Fluorouracil Injection)；LV(Calcium Folinate Injection)

What is being measured

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

  1. MTD

    Maximum tolerated dose for patients in combination treatment.

    Measured: 18 months

  2. RP2D

    Recommended phase II dose for patients in combination treatment.

    Measured: 18 months

Secondary outcomes (12)

  1. Frequency and severity of AEs/SAEs as Assessed by CTCAE v5.0

    Through laboratory test, physical examination, vital signs,12-lead electrocardiogram (ECG), Echocardiogram, etc.;

    Measured: From first dose to death; until the data cut off 18 months after the last subject is enrolled. The minimum time in follow up was 18 months.

  2. Objective Response Rate (ORR)

    Number of reported responses (complete [CR] and partial [PR]) divided by the number of reported assessable patients.

    Measured: From first dose to death; until the data cut off 18 months after the last subject is enrolled. The minimum time in follow up was 18 months.

  3. Disease Control Rate (DCR)

    Based on investigator reviewed radiographic tumour assessment and death.

    Measured: From first dose to death; until the data cut off 18 months after the last subject is enrolled. The minimum time in follow up was 18 months

  4. Duration of Response (DoR)

    Based on investigator reviewed radiographic tumour assessment and death.

    Measured: From first dose to death; until the data cut off 18 months after the last subject is enrolled. The minimum time in follow up was 18 months.

  5. Progression-Free Survival (PFS)

    Based on change in tumour per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1

    Measured: From first dose to death; until the data cut off 18 months after the last subject is enrolled. The minimum time in follow up was 18 months.

  6. Overall Survival (OS)

    Based on investigator reviewed radiographic tumor assessment and death.

    Measured: From first dose to death; until the data cut off 18 months after the last subject is enrolled. The minimum time in follow up was 18 months.

  7. Cmax

    peak plasma concentration

    Measured: 28days

  8. Tmax

    time to peak concentration

    Measured: 28days

  9. AUC

    area under the plasma concentration versus time curve

    Measured: 28days

  10. t1/2z

    elimination half-life

    Measured: 28days

  11. Vss

    steady-state apparent volume of distribution

    Measured: 28days

  12. CL

    clearance

    Measured: 28days

Timeline

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

  1. First posted15 Mar 2021
  2. Study start8 Apr 2021
  3. Primary completion28 Jun 2024
  4. Study completion28 Jun 2024

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A dose-escalation and expansion study
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04796948
Sponsor's protocol ID
HR-YLTKL-101
Status last verified
Apr 2025
First submitted
8 Mar 2021
Last updated
29 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xu Q, Zhao X, Wang X, Zhu R, Cheng Y, Xia T, Wu H, Tian H, Sun Y, Zhang M, Gao C, Fu D, Wu X, Zheng T, Yin X, Chen Y, Chen X, Li Z, Chen R, Yang X, Wang H, Wang Q, Han X, Wu W. Phase 1 trial of HR070803 (an Irinotecan liposome) in combination with 5-fluorouracil, leucovorin, and oxaliplatin for untreated advanced or metastatic pancreatic ductal adenocarcinoma. BMC Med. 2025 Jul 7;23(1):402. doi: 10.1186/s12916-025-04234-4.

    PubMed 40619376

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Irinotecan liposome；oxaliplatin；5-FU(Fluorouracil Injection)；LV(Calcium Folinate Injection) in people with Advanced Pancreatic Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

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 8 inclusion and 9 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: finished, as of the sponsor's last update on 29 Apr 2025. 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD (time frame: 18 months). The study lists 2 primary outcomes in all. 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 NCT04796948, 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 29 Apr 2025.

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