The goal of this interventional study is to learn about the clinical efficacy of sequential therapy (albumin paclitaxel, gemcitabine combined with PD-L1 antibodies, followed by liposomal irinotecan, oxaliplatin and 5-FU/LV combined with PD-L1 antibodies). The main questions it aims to answer are: Does the sequential therapy increase the resection rate of borderline resectable / locally advanced pancreatic cancer? Does the sequential therapy represent an effective and safe treatment? Participants will receive two distinct chemotherapy regimens, each combined with a PD-L1 antibody, administered in sequence for two cycles each.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
77
The cohort A (borderline resectable) and cohort B (locally advanced) both received treatment with gemcitabine, albumin paclitaxel (administered on days 1, 8, and 15, with 4 weeks as one cycle) and adalimumab (administered once every 4 weeks, with 4 weeks as one cycle). After completing 2 cycles of treatment, they were sequentially given liposomal irinotecan combined with 5-FU/LV, oxaliplatin (administered once every 2 weeks, with 4 weeks as one cycle) and adalimumab (administered once every 4 weeks, with 4 weeks as one cycle). After completing 2 cycles of sequential treatment, surgical evaluation was conducted: for patients who could undergo radical surgical resection, surgery was performed within 2-4 weeks after the end of the conversion treatment stage, and the postoperative treatment plan was selected based on the investigator's judgment; for patients who could not undergo radical surgical resection, subsequent treatment plans could be selected based on the investigator's judgment.
18-month overall survival (OS) rate
To test whether the 18-month OS rate of patients with borderline resectable or locally advanced pancreatic cancer treated with the sequential therapy was comparable to that of the historical data of the general adult population.
Time frame: From the date of first enrollment to 18 months later.
Surgical conversion rate
The surgical conversion rate refers to the process of transforming an initially inoperable tumor into one that can be removed through a pre-defined treatment plan. The conversion rate is the proportion of subjects who successfully underwent the conversion treatment among all subjects who received such treatment.
Time frame: From the date of first enrollment to the date of completion of follow-up of the last patient, up to 30 months.
Overall survival rate (OS)
Time frame: From the date of first enrollment to the date of completion of follow-up of the last patient, up to 30 months.
Event-free survival (EFS)
Survival time from the first enrollment to the date of first documented progression or the date of death.
Time frame: From the date of first enrollment to the date of completion of follow-up of the last patient, up to 30 months.
R0 resection rate
The R0 resection rate is defined as the proportion of subjects who were assessed as having achieved R0 resection (complete tumor removal, with no cancer cells found at the microscopic margin, no cancer cells remaining either macroscopically or under the microscope, and the lesion was completely removed) after the surgery.
Time frame: From the date of first enrollment to the date of completion of follow-up of the last patient, up to 30 months.
R1 resection rate
The R1 resection rate is defined as the proportion of subjects who were assessed as having undergone R1 resection (microscopic residual, all large lesions were removed, and there were cancer cells at the microscopic margin) after the surgery.
Time frame: From the date of first enrollment to the date of completion of follow-up of the last patient, up to 30 months.
Objective response rate (ORR)
ORR is defined as the percentage of patients who achieve complete response (CR) or partial response (PR) based on the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
Time frame: From the date of first enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months.
Toxicity and side effects and tolerability assessment
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTCAE Version 5.0.
Time frame: From the date of first therapy administration to within 90 days, up to 30 months.
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