Irinotecan Liposome for Resectable Pancreatic Cancer With or Without Addebelizumab
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University
About this trial
To evaluate the efficacy and safety of irinotecan liposomes with oxaliplatin, 5-fluorouracil (5-FU) / leucovorin (LV) with or without adelizumab for resectable pancreatic cancer by assessing the 12-month EFS rate
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 18 years old, male or female;
According to the NCCN clinical practice guidelines (2023.V2 version), multidisciplinary and imaging evaluation for patients with resectable pancreatic cancer, resectable defined as: by imaging examination, the criteria of radical resection of tumor is no distant metastasis, the artery (trunk celiac, superior mesenteric artery or common hepatic artery), and the tumor did not invade the superior mesenteric vein and portal vein, or invasion but not more than 180 and the venous contour is normal.
Have not received any anti-tumor therapy (including radiotherapy, ablation, chemotherapy, targeted therapy, immunotherapy, etc.) or research drug therapy; 4. At least one measurable lesion must be used as the target lesion (according to the RECIST v1.1 criteria);
Neutrophils 1.5 * 109 / L; platelets 80 * 109 / L; 9 g/dl hemoglobin and 3 g/dl serum albumin;
Disqualifiers
Patients with pancreatic cancer arising from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic acinar cell carcinoma, pancreatic pancreoblastoma, and solid-pseudopapillary tumors;
Patients with known central nervous system metastases;
Severe gastrointestinal dysfunction (bleeding, obstruction; inflammation greater than grade 2; diarrhea greater than grade 1);
Within 2 weeks before randomization, the third space effusion (such as a large amount of pleural fluid) (no intervention after removing the drainage tube);
Trial design
Design model
Parallel
Treatments tested in this trial
irinotecan liposome + oxaliplatin + 5-FU / LV
DrugEfficacy and safety of irinotecan liposome combined with oxaliplatin, 5-fluorouracil (5-FU) / leucovorin calcium (LV) with or without adbellizumab for resectable pancreatic cancer
Adebellizumab
DrugEfficacy and safety of irinotecan liposome combined with oxaliplatin, 5-fluorouracil (5-FU) / leucovorin calcium (LV) with or without adbellizumab for resectable pancreatic cancer
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: Arm AExperimental treatment 2 interventions
Group B: Arm BExperimental treatment 1 intervention
Group C: Arm CActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
12-month EFS rate
the proportion of subjects with EFS events within one year.
Time frame
Up to 2 years.Secondary outcomes
1
Overall Survival
Defined as the time from random to death from any cause
Time frame
Up to 2 years.2
Event free survival
Defined as the time from randomization to disease progression, disease recurrence or death from any cause.
Time frame
Up to 2 years.3
Disease free survival
Defined as the time from randomization to disease recurrence or death from any cause.
Time frame
Up to 2 years.4
Objective response rate
Evaluation of the ORR by the investigator per RECIST v1.1 criteria means the proportion of subjects with the best overall efficacy of CR or PR. If the efficacy reaches CR and PR, the subject must be reviewed 4 weeks after the initial evaluation.
Time frame
Up to 2 years.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: