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

NCT04216758 | Unknown Phase 2

• 1 other identifier: CSPAC-23
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Recurrence free survival (RFS)

  To evaluate the therapeutic efficacy of comparison of Nab-Paclitaxel combined with Gemcitabine and Gemcitabine combined with Tegafur chemotherapy in terms of recurrence-free survival in patients with pancreatic cancer after curative resection. Computed tomography (CT) scan

  From date of the first day after surgery until the date of the recurrence of the disease (local recurrence and/or distant metastasis) or death from any cause,whichever came first, assessed up to 20 months

Secondary Outcomes (4)

• Overall survival (OS)

  From date of enrollment (after curative resection) until the date of death from any cause, assessed one month during therapy and 3 months thereafter

• Quality of life (Qol)

  One month during therapy and 3 months thereafter

• Number of grade 3 and 4 toxicities according to NCI CTCAE version 4.0

  One week during therapy and 3 months thereafter

• CA199 level after curative resection

  One month during therapy and 3 months thereafter

Study Arms (2)

nab-paclitaxel + gemcitabine

EXPERIMENTAL

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

Drug: nab-paclitaxel; Drug: Gemcitabine

tegafur + gemcitabine

EXPERIMENTAL

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

Drug: Gemcitabine; Drug: tegafur

Interventions

nab-paclitaxel 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.

Also known as: Abraxane

nab-paclitaxel + gemcitabine

Gemcitabine 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.

Also known as: Gemzar

nab-paclitaxel + gemcitabine; tegafur + gemcitabine

tegafur 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.

tegafur + gemcitabine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

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

Shanghai, 200032, China

RECRUITING

MeSH Terms

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine; Tegafur

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones

Study Officials

• Xian-Jun Yu, M.D Ph.D

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xian-jun Yu, M.D Ph.D

CONTACT

+86-21-64175590; wangwenquan@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: January 3, 2020
• Study Start: January 1, 2020
• Primary Completion: July 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)