Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer

NCT ID: NCT03815461

Last Updated: 2019-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2023-10-02

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.

Conditions

Locally Advanced Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experiment group

Nab-paclitaxel+S-1

Group Type: EXPERIMENTAL

Nab-paclitaxel and S-1

Intervention Type: DRUG

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.

Interventions

Nab-paclitaxel and S-1

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Aiping Zhou

Cancer Hospital & Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhou Aiping

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center/Cancer Hospital, China

Locations

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, , China

Countries

China

Central Contacts

Zhou Aiping

Role: CONTACT

zhouap1825@126.com

+86 13691161998

Zhou Aiping

Role: CONTACT

Facility Contacts

Zhou Aiping

Role: primary

zhouap1825@126.com

+86 13691161998

Other Identifiers

CSPC-KAL-PC-05

Identifier Type: -

Identifier Source: org_study_id