Clinical trial NCT03815461: Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer
Official title: Phase II Clinical Study of Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Locally Advanced Pancreatic Cancer
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2019-01-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PFS
timeFrame: up to 2.5 years
Secondary outcomes:
measure: R0 resection rate
timeFrame: 6 months
measure: Overall survival rate
timeFrame: 2 years
measure: Overall survival
timeFrame: up to 2.5 years
measure: Adverse reaction rate
timeFrame: up to 2.5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
affiliation: National Cancer Center/Cancer Hospital, China
name: Zhou Aiping
role: PRINCIPAL_INVESTIGATOR
References: