Phase 2 Trial of Gemcitabine vs S-1 vs Gemcitabine Plus Nab-paclitaxel as Adjuvant Chemotherapy of Post-operative Pancreatic Cancer Patients

Pancreatic cancer is one of the deadliest tumor types, there is no effective treatment method clinically. Recently radical surgical resection is recommended for this cancer, How to improve the survival rate of patients is the doctors' goals . Postoperative chemotherapy can partly raise post-operative survival rate. the purpose of this study is to three chemotherapy regimens(gemcitabine monotherapy, S-1 monotherapy and combining nab-paclitaxel with gemcitabine),which is best regimens for raising patients' survival rate, and will provide a chemotherapy choice for clinic therapy of pancreatic cancer.

Study Overview

• Status: Unknown
• Conditions: Cancer of Pancreas
• Intervention / Treatment: Drug: Nab-paclitaxel plus Gemcitabine; Drug: Gemcitabine monotherapy; Drug: S-1 monotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Dabin Xu, M.D.; Phone Number: 8613522065659; Email: xdabin@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed informed-consent form.
2. Man or woman aged 18 years to 80 years.
3. Histologically confirmed pancreatic carcinoma, and the histological type is ductal adenocarcinoma.
4. Mild (Child-Pugh A), moderate (Child-Pugh B) and some preferable severe (Child-Pugh C, <=10) hepatic dysfunction according to the Child-Pugh Scoring system criteria.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3, with life expectation of no less than 12 weeks.
6. Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) ≥1.5 x 109/L; platelets ≥ 70 x 109/L; hemoglobin ≥ 8.0 g/dL.
7. Albumin ≥ 30 g/L.
8. Adequate hepatic function as evidenced by Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 5 x upper limit of normal (ULN); Serum total bilirubin ≤ 1.5 x ULN; Serum creatinine ≤ 1.5 x ULN.
9. Females of childbearing potential must have a negative serum pregnancy test and must not breast-feed before the first dose. Male also need contraception.
10. Willing and able to comply with study procedures for the duration of the study.

Exclusion Criteria:

1. Hypertension, and unable to drop to normal level (systolic pressure >140 mmHg, diastolic pressure >90 mmHg) after treatment.

2. Patients have active cardiac disease including any of the following:

   1. In resting state, average correction QTc > 470 msec on mean value of 3 times screening ECGs.
   2. Any clinically significant abnormal ECG form, for example, complete left bundle branch block, 3-degree atrioventricular block, 2-degree atrioventricular block, or PR interval > 250 msec.
   3. Any factors may increase the risk of QTc prolongation or arrhythmic event.
   4. Left ventricular ejection fraction (LVEF) < 50%.
3. Patient weight still in losing period.
4. History of gastrointestinal bleeding or a gastrointestinal bleeding tendency, such as esophageal varices with high risk of bleeding, local active ulcerative lesions, fecal occult blood test>= (+ +) within the past 6 months, shall not enter the trial. If fecal occult blood test (+), the patient is requested for gastroscopy.
5. Patients with abdominal fistula, gastrointestinal perforation or abdominal abscess within the past 28 days, should not enter the trial.
6. Patients with coagulant function abnormality (INR > 1.5 or prothrombin time (PT) > ULN + 4 sec), with bleeding tendency or are treated with thrombolytic or anticoagulant therapy.
7. Patients with unstable or serious concurrent medical conditions are excluded. The researcher evaluates that the patient who is not suitable for participation in the study. Patients with active infection, for example, HBV, HCV, or HIV.
8. Uncontrollable nausea, vomit, chronic gastrointestinal disorders leading to unable to swallow drugs, which may affect the fully absorption of S-1.
9. Patients with mental illness, or with psychiatric history of drug abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nab-paclitaxel plus Gemcitabine; Nanoparticle albumin-bound paclitaxel is given at 100mg/m2 intravenously over 30 minutes in combination with Gemcitabine 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.	Drug: Nab-paclitaxel plus Gemcitabine; Nanoparticle albumin-bound paclitaxel is given at 100mg/m2 intravenously over 30 minutes in combination with Gemcitabine 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.; Other Names: nab-paclitaxel abraxane ABI-007; GEMXAR
Experimental: Gemcitabine monotherapy; Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.	Drug: Gemcitabine monotherapy; Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.; Other Names: GEMXAR
Experimental: S-1 monotherapy; S-1 is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.	Drug: S-1 monotherapy; S-1 is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival(DFS)	To determine the DFS of post-operative patients with pancreatic cancer	3 years
overall survival time (OS)	To determine the OS post-operative patients with pancreatic cancer	5 years
median overall survival time (mOS)	To determine the mOS post-operative patients with pancreatic cancer	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate(ORR)	All patients must be considered in response analysis, including those who discontinue treatment or who die for any reason prior to response evaluations	3 years
Quality of Life Assessment		3 years
safety profile	Treatment-emergent adverse events, drug-related adverse events will be analysed by 3 groups	3 years
Disease control rate(DCR)		3 years

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2017
• Primary Completion (Anticipated): March 31, 2018
• Study Completion (Anticipated): September 30, 2018

Study Registration Dates

• First Submitted: September 8, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (Actual): September 11, 2017

Study Record Updates

• Last Update Posted (Actual): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 8, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: S-1; nab-paclitaxel
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Gemcitabine; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: XDB-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No