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

Locally Advanced Pancreatic Cancer Clinical Trial

Official title:

Phase II Clinical Study of Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03815461
• Other study ID #: CSPC-KAL-PC-05
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 1, 2019
• Est. completion date: October 2, 2023

Study information

• Verified date: January 2019
• Source: Chinese Academy of Medical Sciences
• Contact: Zhou Aiping
• Phone: +86 13691161998
• Email: zhouap1825[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Locally Advanced Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS		up to 2.5 years
Secondary	R0 resection rate		6 months
Secondary	Overall survival rate		2 years
Secondary	Overall survival		up to 2.5 years
Secondary	Adverse reaction rate		up to 2.5 years