Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based TherapyPhase 3NCT05074589
Irinotecan Liposome in Combination With 5-FU/LV Versus 5-FU/LV in Second-line Therapy for Gemcitabine-Refractory Pancreatic Cancer
A Phase 3 study testing Irinotecan liposome、5-Fluorouracil、Leucovorin in people with Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
To evaluate efficacy and safety of irinotecan hydrochloride liposome in combination with 5-FU/LV as second-line treatment for locally advanced or metastatic pancreatic cancer after treatment failure with gemcitabine-based therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy
- What is being tested?
- Irinotecan liposome、5-Fluorouracil、Leucovorin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 298 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2018to 10 Mar 2022
- Phase
- Phase 3
- 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
- Histologically or cytologically confirmed pancreatic cancer;
- Unresectable locally advanced or metastatic disease ;
- Documented disease progression after first-line treatment gemcitabine based therapy
- ECOG: 0-1;
- Adequate organ and bone marrow function;
- sign an informed consent.
Who cannot join
- Active CNS metastasis;
- Uncontrolled tumor-related pain;
- Clinically significant GI disorders;
- Significant cardiovascular disease;
- Active infection or uncontrolled fever;
- Pregnant or breast feeding patients;
- Allergic to a drug ingredient or component;
- The investigators determined that other conditions were inappropriate for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Qinhuai Medical Area, General Hospital of PLA Eastern Theater Command
Nanjing, Jiangsu
About this study
Official title: A Randomized, Double-blind, Single-dummy, Parallel-controlled, Multicentre, Phase III Clinical Study of Irinotecan Hydrochloride Liposome in Combination With 5-FU/LV as Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy
To evaluate efficacy and safety of irinotecan hydrochloride liposome in combination with 5-FU/LV as second-line treatment for locally advanced or metastatic pancreatic cancer after treatment failure with gemcitabine-based therapy.
- Being tested
- Irinotecan liposome、5-Fluorouracil、Leucovorin, Placebo、5-Fluorouracil、Leucovorin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan liposome、5-Fluorouracil、LeucovorinDrug
Irinotecan liposome、5-Fluorouracil、Leucovorin
Placebo、5-Fluorouracil、LeucovorinDrug
Placebo、5-Fluorouracil、Leucovorin
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Irinotecan liposome plus 5-fluorouracil, Leucovorin Receives: Drug: Irinotecan liposome、5-Fluorouracil、Leucovorin |
| Treatment group B | Active comparator | Placebo plus 5-fluorouracil, Leucovorin Receives: Drug: Placebo、5-Fluorouracil、Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival(OS)
OS is defined as the time from randomization to death due to any cause, or censored at date last known alive.
Measured: The maximum time in follow up was approximately 12 months
Secondary outcomes (5)
Progression Free Survival
Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurs first.
Measured: The maximum time in follow up was 12 months
Objective Response Rate
Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Measured: Assessment every 6 weeks after initial response; maximum time on study 12 months
Time to Treatment Failure
Time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death.
Measured: The maximum time in follow up was 12 months
Percentage of Patients With Tumor Marker (CA 19-9) Response
Response was defined as a decrease of 50% of CA19-9 in relation to the baseline level at least once during the treatment period.
Measured: Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months
Quality of life（QoL）
QoL was based on EORTC-QLQ-C30
Measured: Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start25 Jan 2018
- Primary completion18 Nov 2021
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based TherapyStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-blind, single-dummy, parallel-controlled, multicentre study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074589
- Sponsor's protocol ID
- HR-IRI-APC
- Status last verified
- Aug 2023
- First submitted
- 29 Sep 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cui J, Qin S, Zhou Y, Zhang S, Sun X, Zhang M, Cui J, Fang W, Gu K, Li Z, Wang J, Chen X, Yao J, Zhou J, Wang G, Bai Y, Xiao J, Qiu W, Wang B, Xia T, Wang C, Kong L, Yin J, Zhang T, Shen X, Fu D, Gao C, Wang H, Wang Q, Wang L. Irinotecan hydrochloride liposome HR070803 in combination with 5-fluorouracil and leucovorin in locally advanced or metastatic pancreatic ductal adenocarcinoma following prior gemcitabine-based therapy (PAN-HEROIC-1): a phase 3 trial. Signal Transduct Target Ther. 2024 Sep 19;9(1):248. doi: 10.1038/s41392-024-01948-4.
PubMed 39300077
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single-dummy, Parallel-controlled, Multicentre, Phase III Clinical Study of Irinotecan Hydrochloride Liposome in Combination With 5-FU/LV as Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy
- ClinicalTrials.gov ID
- NCT05074589
- Acronym / sponsor ID
- HR-IRI-APC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate efficacy and safety of irinotecan hydrochloride liposome in combination with 5-FU/LV as second-line treatment for locally advanced or metastatic pancreatic cancer after treatment failure with gemcitabine-based therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, double-blind, single-dummy, parallel-controlled, multicentre study
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: Irinotecan liposome、5-Fluorouracil、LeucovorinIrinotecan liposome plus 5-fluorouracil, Leucovorin |
| Treatment group B | Active comparator | Drug: Placebo、5-Fluorouracil、LeucovorinPlacebo plus 5-fluorouracil, Leucovorin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed pancreatic cancer;
- Unresectable locally advanced or metastatic disease ;
- Documented disease progression after first-line treatment gemcitabine based therapy
- ECOG: 0-1;
- Adequate organ and bone marrow function;
Key exclusion criteria (8 listed)
- Active CNS metastasis;
- Uncontrolled tumor-related pain;
- Clinically significant GI disorders;
- Significant cardiovascular disease;
- Active infection or uncontrolled fever;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irinotecan liposome、5-Fluorouracil、LeucovorinIrinotecan liposome、5-Fluorouracil、Leucovorin | Drug | Treatment group A |
| Placebo、5-Fluorouracil、LeucovorinPlacebo、5-Fluorouracil、Leucovorin | Drug | Treatment group B |
Primary outcome
Overall Survival(OS)
Time frame: The maximum time in follow up was approximately 12 months
OS is defined as the time from randomization to death due to any cause, or censored at date last known alive.
5 secondary outcomes
Progression Free Survival
Time frame: The maximum time in follow up was 12 months
Objective Response Rate
Time frame: Assessment every 6 weeks after initial response; maximum time on study 12 months
Time to Treatment Failure
Time frame: The maximum time in follow up was 12 months
Percentage of Patients With Tumor Marker (CA 19-9) Response
Time frame: Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months
Quality of life（QoL）
Time frame: Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Derived from this study: PubMed 39300077Cui J, Qin S, Zhou Y, Zhang S, Sun X, Zhang M, Cui J, Fang W, Gu K, Li Z, Wang J, Chen X, Yao J, Zhou J, Wang G, Bai Y, Xiao J, Qiu W, Wang B, Xia T, Wang C, Kong L, Yin J, Zhang T, Shen X, Fu D, Gao C, Wang H, Wang Q, Wang L. Irinotecan hydrochloride liposome HR070803 in combination with 5-fluorouracil and leucovorin in locally advanced or metastatic pancreatic ductal adenocarcinoma following prior gemcitabine-based therapy (PAN-HEROIC-1): a phase 3 trial. Signal Transduct Target Ther. 2024 Sep 19;9(1):248. doi: 10.1038/s41392-024-01948-4.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Irinotecan liposome、5-Fluorouracil、Leucovorin in people with Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy, 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 6 inclusion and 8 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 14 Aug 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Overall Survival(OS) (time frame: The maximum time in follow up was approximately 12 months). 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 NCT05074589, 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 14 Aug 2023.