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This trial is a prospective, single-arm, single-center, phase II clinical study, mainly targeting subjects with locally advanced pancreatic cancer, to explore the efficacy and safety of adebrelimab combined with irinotecan liposome (II), oxaliplatin, and 5-FU/LV conversion in the treatment of locally advanced pancreatic cancer.
Subjects enter the screening period after being fully informed and signing an informed consent form. The screening period for the study is 28 days.
After completing the screening inspection and evaluation, patients will receive adebrelimab once and irinotecan liposomal (II), oxaliplatin, 5-FU/LV twice per cycle (4 weeks), and imaging of tumor lesions will be performed every 2 cycles (8 weeks ± 7 days) to evaluate whether patients can undergo surgery until surgical resection, disease progression, or intolerable toxicity, start of new anticancer drug therapy, withdrawal from the study, death, or loss to follow-up.
After 6 cycles of treatment, patients who are assessed to have no progression but are still unable to undergo radical surgical resection will receive maintenance treatment regimen (using capecitabine or teggio plus adebrelimab), and imaging efficacy will be evaluated every 12 weeks (± 7 days) during maintenance treatment. Surgical resectability will still be evaluated during maintenance treatment until disease progression or intolerable toxicity, start of new anticancer drug treatment, withdrawal from the study, death, or loss to follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adebrelimab combined with irinotecan liposomal (II), oxaliplatin, and 5-FU/LV | Experimental | Adebrelimab combined with irinotecan liposomal (II), oxaliplatin, and 5-FU/LV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab combined with irinotecan liposomal (II), oxaliplatin, and 5-FU/LV | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical conversion rate | Refers to the proportion of subjects with successful conversion to all subjects receiving conversion therapy. Achievement of R0/R1 resection after conversion therapy was defined as successful conversion. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Time from start of patient treatment to death from any cause | 5 years |
| 1-year OS rate | Proportion of subjects who have survived 1 year from the date of first treatment after enrollment to all treated subjects |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related adverse events | Observe all patients for any adverse events during the clinical study, including abnormalities in clinical symptoms and vital signs, abnormalities in laboratory tests, record their clinical manifestation characteristics, severity, time of occurrence, duration, treatment methods and prognosis, and determine their correlation with the investigational drug. | Up to 3 years |
Inclusion Criteria:
-
Patients must meet all of the following inclusion criteria to be enrolled in this trial:
Sign written informed consent before implementing any trial-related procedures;
Age ≥ 18 years old and ≤ 70 years old, regardless of gender;
Locally advanced pancreatic cancer confirmed by histopathological/cytopathological examination;
Patients with locally advanced stage and no previous anti-tumor treatment (radiotherapy, chemotherapy, targeted or immunotherapy, etc.);
Definition of locally advanced pancreatic cancer:
According to the efficacy evaluation criteria of solid tumors (RECIST version 1.1) with at least one radiographically measurable lesion;
ECOG score 0-1;
If the biliary obstruction needs to be lifted, the expected survival time is > 3 months;
Sufficient organ function, subjects must meet the following laboratory indicators:
For female subjects of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days prior to the first dose of study drug (Cycle 1, Day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is ordered. Women of non-childbearing age are defined as at least 1 year after menopause, or have undergone surgical sterilization or hysterectomy;
If there is a risk of conception, all subjects (whether male or female) are required to use contraception with an annual failure rate of less than 1% throughout the entire treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy drug).
Exclusion Criteria:
-
Subjects who meet any of the following criteria will not be allowed to enter the study:
Note: Subjects with hepatitis B who meet the following criteria can also be enrolled:
(17) pregnant or breastfeeding women; (18) Presence of any serious or uncontrollable systemic disease, such as:
(19) Medical history or disease evidence that may interfere with the results of the trial, prevent the subject from participating in the whole study, abnormal treatment or laboratory test values, or other situations that the investigator believes are not suitable for enrollment. The investigator believes that there are other potential risks that the investigator is not suitable for participating in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu | 025 | China |
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|
| 1 year |
| Objective response rate (ORR) | Proportion of subjects including complete response (CR) or partial response (PR) | Up to 3 years |
| Event-free survival (EFS) | The EFS endpoint is a composite time-to-event endpoint, and the "treatment failure" event is defined as the earliest occurrence of the following events: a. Failure to achieve local disease-free status after completion of conversion therapy and/or surgery (i.e., failed resection or disease progression resulting in inoperability); b. Local or distant recurrence; c. Death; | Up to 3 years |
| Disease Control Rate (DCR) | Proportion of subjects whose best response observed throughout the study was CR, PR, or stable disease (SD) | Up to 3 years |
| Duration of response (DoR) | From the first tumor response (CR or PR) to disease progression (PD) or death (whichever occurs earlier) | Up to 3 years |
| Time to disease progression (TTP) | The time from the date of enrollment to the first observation of PD | Up to 3 years |
| CA19-9 Response Rate | Tumor marker response rates were assessed by changes in CA19-9 serum concentrations. Tumor marker response was defined as at least one concentration reduction of at least 50% from baseline occurring during the course of treatment. Only subjects with baseline values greater than the upper detection limit will be included in the evaluation of tumor marker response. | Up to 3 years |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C584112 | irinotecan sucrosofate |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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