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Trial Title:
Irinotecan Liposome II in Combination With 5-FU/LV and Oxaliplatin in Perioperative Treatment of Borderline Resectable Pancreatic Cancer
NCT ID:
NCT06387810
Condition:
Borderline Resectable Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Oxaliplatin
Irinotecan
Conditions: Keywords:
perioperative treatment, irinotecan liposome II
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
irinotecan liposome II combined with 5-FU/LV and oxaliplatin
Description:
irinotecan liposome II: 60mg/m2, intravenously for at least 90min, D1, administered every
2 weeks; oxaliplatin: 85 mg/m2, intravenous infusion, D1, every 2 weeks; calcium
leucovorin: 400 mg/m2, 30±10min intravenously, D1, every 2 weeks; 5-fluorouracil: 2400
mg/m2 intravenously for 46-48 hours or according to study Center clinical practice, D1,
administered every 2 weeks.
Irinotecan liposome II, oxaliplatin, LV and 5-FU were given successively, and
corresponding prophylactic administration could be selected according to clinical needs.
Arm group label:
Combined treatment group
Other name:
surgery
Summary:
This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of
irinotecan liposome II in combination with oxaliplatin and 5-FU/LV in perioperative
treatment of borderline resectable pancreatic cancer in 45 patients.
Detailed description:
This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of
irinotecan liposome II in combination with oxaliplatin and 5-FU/LV in perioperative
treatment of borderline resectable pancreatic cancer in 45 patients.
After screening and signing informed consent, patients who met the admission requirements
received neoadjuvant therapy with irinotecan liposome II combined with 5-FU/LV and
oxaliplatin before surgery (once every 2 weeks, every 2 weeks). After completing 4 cycles
of preoperative neoadjuvant therapy, surgical evaluation was performed:
For patients evaluated for radical surgical resection, surgery was performed within 2 to
4 weeks after the end of neoadjuvant therapy, abdominal enhanced CT/MRI was performed
within 4 to 6 weeks after surgery, and postoperative adjuvant therapy with irinotecan
liposome II combined with 5-FU/LV and oxaliplatin was performed according to the
investigator's judgment (once every 2 weeks, a 2-week cycle). After the completion of 4
cycles of postoperative adjuvant therapy, the tumor progression follow-up/survival
follow-up stage was entered.
Patients who were assessed as not eligible for radical surgical resection could choose
follow-up treatment according to the investigator's judgment, and continue to follow up
their survival until withdrawal of informed consent or death.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- According to the NCCN Clinical Practice Guidelines for Pancreatic Cancer (2024.V1
edition), patients with critically resectable pancreatic cancer.
- Have at least one measurable lesion as a target lesion (according to RECIST v1.1);
- Have not received any anti-tumor therapy (including radiotherapy, ablation,
chemotherapy, targeting, immunotherapy, etc.) or investigational drug therapy;
- ECOG: 0 ~ 1;
- Expected survival ≥3 months;
- Adequate organ and blood function
Exclusion Criteria:
- Pancreatic cancer of non-pancreatic ductal origin includes patients with pancreatic
neuroendocrine carcinoma, pancreatic acinar cell carcinoma, pancreatic blastoma, and
solid pseudopapillary tumor
- Severe gastrointestinal dysfunction
- Severe infection occurred within 4 weeks prior to initiation of treatment (CTCAE >
Grade 2)
- Blood clotting is abnormal, has a tendency to bleed, or is receiving thrombolytic or
anticoagulant therapy
- Have clinical symptoms or diseases of heart that are not well controlled, such as:
(1) NYHA grade 2 or above heart failure; (2) Unstable angina pectoris; (3)
Myocardial infarction occurred within 6 months; (4) Patients with clinically
significant supraventricular or ventricular arrhythmias requiring treatment or
intervention
- Known allergy to irinotecan liposome II, other liposome products, oxaliplatin, 5-FU,
calcium leucovorin, and any component of the above products
- Known peripheral neuropathy (CTCAE≥ Grade 3)
- In the investigator's judgment, subjects had other factors that might have led to
their being forced to terminate the study, such as non-adherence to the protocol,
other serious medical conditions (including mental illness) requiring combined
treatment, clinically significant abnormalities in laboratory test values, or family
or social factors that might affect subjects' safety or the collection of trial data
Gender:
All
Minimum age:
18 Years
Maximum age:
110 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Dingyan Cao, Dr.
Email:
caodingyan@pumch.cn
Start date:
April 17, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06387810
