Borderline Resectable Pancreatic Cancer
Conditions
Keywords
perioperative treatment, irinotecan liposome II
Brief 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.
Interventions
DRUGirinotecan liposome II combined with 5-FU/LV and oxaliplatin
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.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| event free survival | 5 years | The time between the date the subject started treatment and the occurrence of tumor progression leading to inoperability, postoperative recurrence/metastasis, or death, whichever occurred first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 5 years | The time from the start of treatment until death from any cause |
| R0 resection rate | 2 years | R0 resection rate, defined as postoperative assessment of R0 resection (complete resection of the tumor, no cancer cells found on the margin of resection under the microscope, no cancer cells remaining under the naked eye or microscope, complete resection of the lesion). The proportion of subjects. |
| R1 excision rate | 2 years | R1 excision rate, defined as postoperative assessment of R1 excision (microscopic residual, removal of all large lesions, submicroscopic margin of cancer). The proportion of subjects; |
| adverse event | 5 years | Adverse events (AE)/Serious Adverse Events (SAE) (as determined by NCI-CTCAE 5.0) |
Countries
China
Contacts
Primary ContactWenming Wu, doctor
Backup Contact+86 010-69156053 Wu, doctor
Outcome results
None listed