Locally Advanced Pancreatic Cancer
Conditions
Brief summary
This single-arm, Phase II clinical trial is to evaluate the efficacy and safety of nab-paclitaxel plus S-1 in locally advanced pancreatic cancer who were borderline resectable or unresectable .
Detailed description
This single-arm, Phase II clinical trial is to evaluate the efficacy and safety of nab-paclitaxel plus S-1 in locally advanced pancreatic cancer who were borderline resectable or unresectable . Nab-paclitaxel was administered at 125mg/m2 intravenously on day 1 and 8, S-1 （80, 100, or 120 mg/d according to body-surface area on days 1 through 14 of a 21-day cycle for 4-6 cycles. During the study, if the subject's weight change was ≤10% from baseline, the dose was calculated based on the measured value at baseline. If the change was \>10%, the body surface area of the subject should be recalculated and the dose administered should be adjusted. . Study treatment period Borderline resectable: According to the results of imaging examination, MDT discussed to determine the surgical resectability and timing of surgery. The chemotherapy time was 4-6 cycles. Unresectable: Chemotherapy for up to 6 cycles. According to the results of imaging examination, MDT determined the resectability of the operation. It was decided by the investigator and the patient to continue chemotherapy (S-1 maintenance), surgery or radiotherapy.
Interventions
Nab-paclitaxel was administered at 125mg/m2 intravenously on day 1 and 8, S-1 （80, 100, or 120 mg/d according to body-surface area on days 1 through 14 of a 21-day cycle for 4-6 cycles.
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patient compliance is good, the research process of this study can be understood, and written informed consent is signed; * Age ≥ 18 years old, ≤ 75 years old; * Histologically or cytologically confirmed pancreatic adenocarcinoma； * no prior treatment; * Based on imaging findings, MDT decided patients intoborderline resectable (group A) or unresectable (group B) (according to the resectability assessment criteria in the 2018 Pancreatic Cancer Comprehensive Care Guidelines); * ECOG\<2; * Bone marrow function: hemoglobin (HGB) ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; platelets (PLT) ≥ 100 × 109 / L; * Liver function: ALT, AST ≤ 2.5 × upper limit of normal (ULN), if there is liver metastasis, ALT, AST ≤ 5 × ULN; serum total bilirubin \< 1.5 × ULN; * Renal function: serum creatinine is within normal range; * Patients without biliary obstruction, patients requiring biliary stent implantation must be completed at least 7 days prior to enrollment; * Non-pregnant and lactating women, women of reproductive age/male should take effective contraceptive measures during the study period and within 6 months after the end of the study treatment; * No contraindication to the use of S-1and albumin-bound paclitaxel.
Exclusion criteria
* Patients who have had other malignant tumors within 5 years (except for cured cervical cancer in situ or non-melanoma skin cancer); * Interstitial pneumonia or pulmonary fibrosis; * Severe pleural effusion or ascites; * Watery diarrhea; * There are serious concomitant diseases: such as HIV-positive,chronic HBV/HCV in active period, people who have diabetes and poorly controlled by hypoglycemic drugs, clinically severe (ie, active) heart disease, uncontrolled epilepsy, central nervous system disease or mental disorder; * Current or previous patients with grade II peripheral neuropathy; * Abnormal digestive tract or metabolic function, which may affect the s-1 absorber; * Participated in other clinical researchers within 4 weeks prior to enrollment; * Patients who have undergone organ transplantation; * Patients considered by the investigator to be unfit for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS | up to 2.5 years |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate | 6 months |
| Overall survival rate | 2 years |
| Overall survival | up to 2.5 years |
| Adverse reaction rate | up to 2.5 years |
Countries
China
Contacts
Primary ContactZhou Aiping
Backup ContactZhou Aiping
Outcome results
None listed