Second-line Irinotecan Liposome Combination Regimen For Irinotecan-treated Pancreatic Cancer

Study Overview

Second-line Irinotecan Liposome Combination Regimen for Irinotecan-treated Pancreatic Cancer

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.

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

Pancreatic Cancer

DRUG: Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinate

CSPC-DEY-PAAD-GD01

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-11-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-11-19
First Submitted that Met QC Criteria 2024-11-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-11-22
First Posted (ACTUAL) 2024-11-22	Results First Posted N/A	Last Verified 2024-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
OTHER: Patients with progression within 3 months of completion of irinotecan treament 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 f	DRUG: Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinate Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinate，Every 2 weeks until disease progression or patient develops intolerable toxicity
OTHER: Cohort 2: Patients with disease progression after 3 months of the end of irinotecan treatment 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	DRUG: Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinate Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinate，Every 2 weeks until disease progression or patient develops intolerable toxicity

Participant Group/Arm

Intervention/Treatment

OTHER: Patients with progression within 3 months of completion of irinotecan treament

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 f

DRUG: Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinate

Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinate，Every 2 weeks until disease progression or patient develops intolerable toxicity

OTHER: Cohort 2: Patients with disease progression after 3 months of the end of irinotecan treatment

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

DRUG: Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinate

Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinate，Every 2 weeks until disease progression or patient develops intolerable toxicity

Primary Outcome Measures	Measure Description	Time Frame
(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.	1 year

Secondary Outcome Measures	Measure Description	Time Frame
(ORR)	Objective remission rate:Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1	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	1 year
(OS)	Defined as the time between the date of randomization and death due to various causes	1 year
Incidence of adverse events	Use NCI-CTCAE version 5.0 for classification and grading	1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Fenghua Wang Fenghua Wang, professor

Phone Number: 0086-13127888505

Email: wangfh@sysucc.org.cn

Study Contact Backup

Name: Guifang Guo Sun at-sen University Cancer Center, professor

Phone Number: 0086-13725117392

Email: guogf@sysucc.org.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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;
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.

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);
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, .-

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record