- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04796948
A Study of Irinotecan Liposome in Advanced Pancreatic Cancer
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100730
- Peking Union Medical College Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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:
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Irinotecan liposome;oxaliplatin;5-FU(Fluorouracil Injection);LV(Calcium Folinate Injection)
|
irinotecan liposome in combination with oxaliplatin and 5-FU/LV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MTD
Time Frame: 18 months
|
Maximum tolerated dose for patients in combination treatment.
|
18 months
|
RP2D
Time Frame: 18 months
|
Recommended phase II dose for patients in combination treatment.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency and severity of AEs/SAEs as Assessed by CTCAE v5.0
Time Frame: 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.
|
Through laboratory test, physical examination, vital signs,12-lead electrocardiogram (ECG), Echocardiogram, etc.;
|
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.
|
Objective Response Rate (ORR)
Time Frame: 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.
|
Number of reported responses (complete [CR] and partial [PR]) divided by the number of reported assessable patients.
|
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.
|
Disease Control Rate (DCR)
Time Frame: 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
|
Based on investigator reviewed radiographic tumour assessment and death.
|
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
|
Duration of Response (DoR)
Time Frame: 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.
|
Based on investigator reviewed radiographic tumour assessment and death.
|
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.
|
Progression-Free Survival (PFS)
Time Frame: 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.
|
Based on change in tumour per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1
|
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.
|
Overall Survival (OS)
Time Frame: 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.
|
Based on investigator reviewed radiographic tumor assessment and death.
|
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.
|
Cmax
Time Frame: 28days
|
peak plasma concentration
|
28days
|
Tmax
Time Frame: 28days
|
time to peak concentration
|
28days
|
AUC
Time Frame: 28days
|
area under the plasma concentration versus time curve
|
28days
|
t1/2z
Time Frame: 28days
|
elimination half-life
|
28days
|
Vss
Time Frame: 28days
|
steady-state apparent volume of distribution
|
28days
|
CL
Time Frame: 28days
|
clearance
|
28days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Topoisomerase Inhibitors
- Micronutrients
- Vitamins
- Calcium-Regulating Hormones and Agents
- Topoisomerase I Inhibitors
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Oxaliplatin
- Leucovorin
- Irinotecan
- Calcium
- Levoleucovorin
Other Study ID Numbers
- HR-YLTKL-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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