Nab-P and Gem Compared With Gem and Tegafur in Adjuvant Chemotherapy After Radical Resection of Pancreatic Cancer

NCT ID: NCT04216758

Last Updated: 2020-06-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2020-12-31

Brief Summary

Treatment, Prospective, Assignment, Open Label, Single-center, Non-randomized Study An exploratory clinical trial of comparison of Nab-Paclitaxel combined with Gemcitabine and Gemcitabine combined with Tegafur for adjuvant chemotherapy after radical resection of pancreatic cancer

Detailed Description

Pancreatic cancer has an extremely poor prognosis with a 5-year survival rate of less than 5%. About 25% of patients have the opportunity for radically surgical resection when diagnosis. However, the recurrence rate is up to 85% within 2 years. Data from clinical trials indicated that gemcitabine-based adjuvant chemotherapy reduced recurrence and enhanced overall survival for patients who have undergone surgery to remove their tumor. Nab-paclitaxel could significantly increase the concentration of gemcitabine in the tumor; recent studies showed that nab-paclitaxel plus gemcitabine significantly improved progression-free survival and overall survival of metastatic pancreatic cancer patients. A study in Japan and Taiwan compared the efficacy of gemcitabine in combination with tegafur in patients with locally advanced or metastatic pancreatic cancer. The median progression-free survival was significantly better in the gemcitabine combined with the tegafur group than in the gemcitabine group. The present study is intended to observe the effect of albumin paclitaxel combined with gemcitabine and tegafur combined with gemcitabine on recurrence-free survival in patients with pancreatic adenocarcinoma undergoing radical resection.

Conditions

Stage IA Pancreatic Adenocarcinoma; Stage IB Pancreatic Adenocarcinoma; Stage IIA Pancreatic Adenocarcinoma; Stage IIB Pancreatic Adenocarcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nab-paclitaxel + gemcitabine

nab-paclitaxel at 100 mg/m\^2 on days 1, 8, and 15; gemcitabine at 1000 mg/m\^2 on days 1, 8, and 15

Group Type: EXPERIMENTAL

nab-paclitaxel

Intervention Type: DRUG

Patients firstly receive nab-paclitaxel 100 mg/m\^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

Gemcitabine

Intervention Type: DRUG

Patients receive gemcitabine 1000 mg/m\^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

tegafur + gemcitabine

gemcitabine at 1000 mg/m\^2 on days 1, 8, and 15; tegafur: Body surface area \< 1.25 m\^2, 60 mg/d; Body surface area ≥ 1.25 m\^2 to \< 1.5 m\^2, 80 mg/d; Body surface area ≥ 1.5 m\^2, 100 mg/d; Oral (po), Bid, D1-21

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

Patients receive gemcitabine 1000 mg/m\^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

tegafur

Intervention Type: DRUG

Patients secondly receive tegafur Body surface area \< 1.25 m\^2, 60 mg/d;Body surface area ≥ 1.25 m\^2 to \< 1.5 m\^2, 80 mg/d;Body surface area ≥ 1.5 m\^2, 100 mg/d (po) on days 1-21 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

Interventions

nab-paclitaxel

Patients firstly receive nab-paclitaxel 100 mg/m\^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

Intervention Type: DRUG

Gemcitabine

Patients receive gemcitabine 1000 mg/m\^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

Intervention Type: DRUG

tegafur

Patients secondly receive tegafur Body surface area \< 1.25 m\^2, 60 mg/d;Body surface area ≥ 1.25 m\^2 to \< 1.5 m\^2, 80 mg/d;Body surface area ≥ 1.5 m\^2, 100 mg/d (po) on days 1-21 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

Intervention Type: DRUG

Other Intervention Names

Abraxane; Gemzar

Eligibility Criteria

Inclusion Criteria

• Signed informed content obtained prior to treatment
• Age ≥18 years and ≤ 80 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Pathologically confirmed after R0 resection of pancreatic adenocarcinoma.
• The expected survival after surgery ≥ 6 months
• No serious blood system, heart, lung function abnormalities and immune defects (refer to the respective standards)
• White blood cell (WBC) ≥ 3 × 109/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelets (PLT) ≥ 100 × 109/L; Hemoglobin (Hgb)≥ 9 g/dL
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) ≤ 2.5 × institutional upper limit of normal (ULN); Total bilirubin (TBIL) ≤ ULN; Creatinine (CRE) ≤ 1.5 × ULN
• Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 ×ULN
• Baseline (postoperative) abdominal pelvic CT (plain scan + enhancement) and chest CT scan without tumor lesions;
• No serious adverse events (fatal or life-threatening, persistent or significant loss of function or disability, requiring hospitalization or prolonged hospital stay) within 4-12 weeks after surgery;
• Comply with research visit plans and other program requirements.

Exclusion Criteria

• with other systemic malignancies
• Patients who have received any form of anti-tumor therapy before surgery, including chemotherapy, radiotherapy, interventional chemoembolization, radiofrequency ablation, and molecular targeted therapy
• used any other study drug within 5 weeks prior to enrollment;
• Patients with central nervous system diseases, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled
• Uncontrolled infection, hemorrhage, pancreatic leakage, bile leakage, or other postoperative complications during baseline examination; acute and chronic metabolic acidosis (including ketoacidosis, lactic acidosis) failed to be corrected;
• History of allergic reactions attributed to compounds of similar chemical or biological composition to nab-paclitaxel or gemcitabine or tegafur
• Pregnant or nursing women
• Any condition that may compromise patient safety or study data integrity, including serious medical risk factors, medical conditions, and laboratory abnormalities;
• Patients may leave the observation for 7 days or more during the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xian-Jun Yu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xian-Jun Yu, M.D Ph.D

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xian-jun Yu, M.D Ph.D

Role: CONTACT

wangwenquan@fudanpci.org

+86-21-64175590

Facility Contacts

Xian-Jun Yu, M.D., Ph.D.

Role: primary

yuxianjun88@hotmail.com

+86-21-64175590

Wen-quan Wang, M.D., Ph.D.

Role: backup

wangwenquan@fudanpci.org

+86-21-64175590

Other Identifiers

CSPAC-23

Identifier Type: -

Identifier Source: org_study_id