Pancreatic CancerPhase 2NCT06700603
Second-line Irinotecan Liposome Combination Regimen for Irinotecan-treated Pancreatic Cancer
A Phase 2 study testing Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinate in people with Pancreatic Cancer, run by Rui-hua Xu, MD, PhD.
Trial summary
This study is a prospective, single-arm, two-cohort phase II clinical study. It is expected to enroll 48 patients with advanced or metastatic pancreatic cancer who have failed prior treatment with irinotecan-containing regimens, including two cohorts: cohort 1 for patients who have progressed within 6 months of the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2024to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. patients are fully aware of the study, participate voluntarily and sign an informed consent form (ICF);
- 2. aged ≥18 years and ≤75 years;
- 3. histologically or cytologically confirmed as pancreatic ductal adenocarcinoma;
- 4. patients with advanced or metastatic pancreatic adenocarcinoma who have failed prior irinotecan-containing regimens and have no more than 3 prior lines of therapy.
- 5. patients with at least one measurable target lesion according to RECIST 1.1 criteria;
- 6. Eastern Cooperative Oncology Group (ECOG) physical status score: 0-1;
Show all 10Show fewer
- 7. expected survival time ≥ 3 months;
- 8. absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, platelets ≥ 90 x 10^9/L and hemoglobin ≥ 90 g/L (not transfused with blood, blood products, or corrected with granulocyte colony-stimulating factor or other hematopoietic-stimulating factor in the 14 days prior to the laboratory test);
- 9. Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal; AST and ALT ≤2.5 times the upper limit of normal (≤5 times the upper limit of normal for patients with hepatic invasion); total bilirubin ≤1.5 times the upper limit of normal (≤3 times the upper limit of normal for patients with hepatic invasion);
- 10. Women of childbearing potential must have had a negative pregnancy test (serum) within 7 days prior to enrollment and be willing to use an appropriate method of contraception for the duration of the trial and for 6 months after the last administration of the test drug.
Who cannot join
- 1. hypersensitivity to any investigational drug or its components;
- 2. concomitant serious uncontrolled concurrent infections or other serious uncontrolled concomitant diseases, moderate or severe renal impairment; (e.g., progressive infections, uncontrollable hypertension, diabetes mellitus, etc.)
- 3. cardiac function and disease consistent with one of the following conditions
- Long QTc syndrome or QTc interval > 480 ms;
- Complete left bundle branch block, degree II or degree III atrioventricular block;
- Severe, uncontrolled arrhythmia requiring pharmacologic therapy;
Show all 20Show fewer
- New York Society of Cardiology classification ≥ grade III; 2. cardiac ejection fraction (LVEF) less than 50%; 3. history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, history of clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormality within 6 months prior to recruitment.
- 4. active hepatitis B or C infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA greater than 1x103 copies/mL; hepatitis C virus RNA greater than 1x103 copies/mL);
- 5. Human Immunodeficiency Virus (HIV) infection (HIV antibody positive);
- 6. imaging confirmation of intestinal obstruction;
- 7. previous or current concurrent other malignancies (except effectively controlled non-melanoma basal cell carcinoma of the skin, carcinoma in situ of the breast/cervix, and other malignancies that have been effectively controlled without treatment within the past five years);
- 8. pregnant and lactating women and patients of childbearing age who do not wish to use contraception;
- 9. patients with other malignant tumors requiring treatment;
- 10. history of pulmonary hemorrhage/coughing up ≥ grade 2 (defined as at least 2.5 mL of bright red blood) within 1 month prior to the first dose;
- 11. a history of arterial embolism, severe hemorrhage (other than hemorrhage due to surgery), or a predisposition to existing embolism or severe hemorrhage within 6 months prior to the first administration of the drug
- 12. a combination of symptomatic brain metastases, meningeal metastases, spinal cord tumor invasion, and spinal cord compression
- 13. use of strong inhibitors or inducers of CYP3A4, CYP2C8, and UGT1A1 within 14 days prior to receiving study drug therapy
- 14. who have used other clinical trial medications within 1 month prior to the first dose;
- 15. female patients who are pregnant or lactating, and subjects of childbearing age who refuse to accept contraceptive measures
- 16. patients who are not suitable for participation in this study in the judgment of the investigator, .-
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Guifang Guo Sun at-sen University Cancer Center, professor contact
About this study
Official title: Phase II Clinical Study of Irinotecan Liposome Combined with 5-FU/LV for the Patients with Advanced Pancreatic Cancer Who Failed to Receive Irinotecan-containing Regimens
This study is a prospective, single-arm, two-cohort phase II clinical study. It is expected to enroll 48 patients with advanced or metastatic pancreatic cancer who have failed prior treatment with irinotecan-containing regimens, including two cohorts: cohort 1 for patients who have progressed within 6 months of the end of adjuvant therapy for early pancreatic cancer with a prior irinotecan regimen or for patients with imaging-confirmed progression within 3 months of the end of first-line therapy for advanced patients, and cohort 2 for patients who have progressed after more than Cohort 2 was for patients who had progressed more than 6 months after adjuvant treatment with previous irinotecan regimen for early-stage pancreatic cancer or more than 3 months after the end of first-line treatment for advanced-stage patients. The study was conducted at the Cancer Prevention and Control Center of Sun Yat-sen University. The study consists of a screening period (within 28 days), a treatment period (until disease progression or intolerable toxicity occurs in patients), and a follow-up period (12 months, safety follow-up and PFS follow-up). Subjects signed informed consent and underwent baseline examinations during the screening period, and patients who met the inclusion exclusion criteria entered the treatment period, and all subjects perfected the relevant examinations specified in the protocol during the treatment to observe safety, tolerability and efficacy. The same subject received only one dosing schedule during the study period. After the treatment period was completed, a follow-up period was entered.
Read the detailed description
Evaluation of the efficacy and safety of irinotecan liposomes in combination with 5-FU/levulinic acid sodium in the treatment of patients with irinotecan-containing regimens for treated advanced pancreatic cancer Prospective, single-arm, dual-cohort phase II clinical study. Cohort 1: Patients with imaging-confirmed progression during or within 3 months of completion of irinotecan treatment Cohort 2: Patients with imaging-confirmed disease progression 3 months after completion of irinotecan treatment
- Conditions
- Pancreatic Cancer
- Being tested
- Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinate
- Keywords
- Irinotecan, pancreatic, Irinotecan liposome
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinateDrug
Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinate，Every 2 weeks until disease progression or patient develops intolerable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Patients with progression within 3 months of completion of irinotecan treament | Other | Cohort 1 was for patients who progressed within 6 months of the end of adjuvant therapy for early pancreatic cancer with a prior irinotecan regimen or for patients with advanced disease who had imaging-confirmed progression within 3 months of the end of first-line therapy. Receives: Drug: Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinate |
| Cohort 2: Patients with disease progression after 3 months of the end of irinotecan treatment | Other | Cohort 2 is for patients who have progressed more than 6 months after the end of adjuvant therapy for early pancreatic cancer on prior irinotecan regimens or more than 3 months after the end of first-line therapy for patients with advanced disease Receives: Drug: Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
(PFS)
Progression-free survival: Defined as time from the date of randomization to first documented disease progression using RECIST version 1.1 by investigator review or death due to any cause, whichever occurred first.
Measured: 1 year
Secondary outcomes (4)
(ORR)
Objective remission rate:Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1
Measured: 1 year
(DCR)
Disease Control Rate:Defined as the percentage of patients who achieved CR, PR, and stable disease (SD) according to RECIST v1.1
Measured: 1 year
(OS)
Defined as the time between the date of randomization and death due to various causes
Measured: 1 year
Incidence of adverse events
Use NCI-CTCAE version 5.0 for classification and grading
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start20 Nov 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cohort 1: Patients with imaging-confirmed progression during or within 3 months of completion of irinotecan treatment Cohort 2: Patients with imaging-proven disease progression 3 months after completion of irinotecan treatment
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rui-hua Xu, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rui-hua Xu, MD, PhD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700603
- Sponsor's protocol ID
- CSPC-DEY-PAAD-GD01
- Status last verified
- Aug 2024
- First submitted
- 6 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Irinotecan Liposome Combined with 5-FU/LV for the Patients with Advanced Pancreatic Cancer Who Failed to Receive Irinotecan-containing Regimens
- ClinicalTrials.gov ID
- NCT06700603
- Acronym / sponsor ID
- CSPC-DEY-PAAD-GD01
- Conditions
- Pancreatic Cancer
- Keywords
- Irinotecan, pancreatic, Irinotecan liposome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Rui-hua Xu, MD, PhDUniversity, hospital or other
- Study start
- 20 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Nov 2024 (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.
This study is a prospective, single-arm, two-cohort phase II clinical study. It is expected to enroll 48 patients with advanced or metastatic pancreatic cancer who have failed prior treatment with irinotecan-containing regimens, including two cohorts: cohort 1 for patients who have progressed within 6 months of the end of adjuvant therapy for early pancreatic cancer with a prior irinotecan regimen or for patients with imaging-confirmed progression within 3 months of the end of first-line therapy for advanced patients, and cohort 2 for patients who have progressed after more than Cohort 2 was for patients who had progressed more than 6 months after adjuvant treatment with previous irinotecan regimen for early-stage pancreatic cancer or more than 3 months after the end of first-line treatment for advanced-stage patients. The study was conducted at the Cancer Prevention and Control Center of Sun Yat-sen University. The study consists of a screening period (within 28 days), a treatment period (until disease progression or intolerable toxicity occurs in patients), and a follow-up period (12 months, safety follow-up and PFS follow-up). Subjects signed informed consent and underwent baseline examinations during the screening period, and patients who met the inclusion exclusion criteria entered the treatment period, and all subjects perfected the relevant examinations specified in the protocol during the treatment to observe safety, tolerability and efficacy. The same subject received only one dosing schedule during the study period. After the treatment period was completed, a follow-up period was entered.
Detailed description
Evaluation of the efficacy and safety of irinotecan liposomes in combination with 5-FU/levulinic acid sodium in the treatment of patients with irinotecan-containing regimens for treated advanced pancreatic cancer Prospective, single-arm, dual-cohort phase II clinical study. Cohort 1: Patients with imaging-confirmed progression during or within 3 months of completion of irinotecan treatment Cohort 2: Patients with imaging-confirmed disease progression 3 months after completion of irinotecan treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cohort 1: Patients with imaging-confirmed progression during or within 3 months of completion of irinotecan treatment Cohort 2: Patients with imaging-proven disease progression 3 months after completion of irinotecan treatment
| Arm | Type | Receives |
|---|---|---|
| Patients with progression within 3 months of completion of irinotecan treament | Other | Drug: Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinateCohort 1 was for patients who progressed within 6 months of the end of adjuvant therapy for early pancreatic cancer with a prior irinotecan regimen or for patients with advanced disease who had imaging-confirmed progression within 3 months of the end of first-line therapy. |
| Cohort 2: Patients with disease progression after 3 months of the end of irinotecan treatment | Other | Drug: Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinateCohort 2 is for patients who have progressed more than 6 months after the end of adjuvant therapy for early pancreatic cancer on prior irinotecan regimens or more than 3 months after the end of first-line therapy for patients with advanced disease |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. patients are fully aware of the study, participate voluntarily and sign an informed consent form (ICF);
- 2. aged ≥18 years and ≤75 years;
- 3. histologically or cytologically confirmed as pancreatic ductal adenocarcinoma;
- 4. patients with advanced or metastatic pancreatic adenocarcinoma who have failed prior irinotecan-containing regimens and have no more than 3 prior lines of therapy.
- 5. patients with at least one measurable target lesion according to RECIST 1.1 criteria;
Key exclusion criteria (20 listed)
- 1. hypersensitivity to any investigational drug or its components;
- 2. concomitant serious uncontrolled concurrent infections or other serious uncontrolled concomitant diseases, moderate or severe renal impairment; (e.g., progressive infections, uncontrollable hypertension, diabetes mellitus, etc.)
- 3. cardiac function and disease consistent with one of the following conditions
- 4. active hepatitis B or C infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA greater than 1x103 copies/mL; hepatitis C virus RNA greater than 1x103 copies/mL);
- 5. Human Immunodeficiency Virus (HIV) infection (HIV antibody positive);
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 (Nal-IRI) in combination with 5-FU/sodium levofolinateIrinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinate，Every 2 weeks until disease progression or patient develops intolerable toxicity | Drug | Cohort 2: Patients with disease progression after 3 months of the end of irinotecan treatment, Patients with progression within 3 months of completion of irinotecan treament |
Primary outcome
(PFS)
Time frame: 1 year
Progression-free survival: Defined as time from the date of randomization to first documented disease progression using RECIST version 1.1 by investigator review or death due to any cause, whichever occurred first.
4 secondary outcomes
(ORR)
Time frame: 1 year
(DCR)
Time frame: 1 year
(OS)
Time frame: 1 year
Incidence of adverse events
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Cancer
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Guifang Guo Sun at-sen University Cancer Center, professor contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinate in people with Pancreatic Cancer, run by Rui-hua Xu, MD, PhD.
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 10 inclusion and 20 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: opening soon, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fenghua Wang Fenghua Wang, professor (0086-13127888505, wangfh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(PFS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.