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

Primary Purpose

Cancer of Pancreas

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Nab-paclitaxel plus Gemcitabine

Gemcitabine monotherapy

S-1 monotherapy

About this trial

This is an interventional treatment trial for Cancer of Pancreas focused on measuring S-1, nab-paclitaxel

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed-consent form.
Man or woman aged 18 years to 80 years.
Histologically confirmed pancreatic carcinoma, and the histological type is ductal adenocarcinoma.
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.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3, with life expectation of no less than 12 weeks.
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.
Albumin ≥ 30 g/L.
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.
Females of childbearing potential must have a negative serum pregnancy test and must not breast-feed before the first dose. Male also need contraception.
Willing and able to comply with study procedures for the duration of the study.

Exclusion Criteria:

Hypertension, and unable to drop to normal level (systolic pressure >140 mmHg, diastolic pressure >90 mmHg) after treatment.
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%.
Patient weight still in losing period.
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.
Patients with abdominal fistula, gastrointestinal perforation or abdominal abscess within the past 28 days, should not enter the trial.
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.
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.
Uncontrollable nausea, vomit, chronic gastrointestinal disorders leading to unable to swallow drugs, which may affect the fully absorption of S-1.
Patients with mental illness, or with psychiatric history of drug abuse.

Sites / Locations

Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Nab-paclitaxel plus Gemcitabine

Gemcitabine monotherapy

S-1 monotherapy

Arm Description

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.

Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.

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.

Outcomes

Primary Outcome Measures

Disease free survival(DFS)

To determine the DFS of post-operative patients with pancreatic cancer

overall survival time (OS)

To determine the OS post-operative patients with pancreatic cancer

median overall survival time (mOS)

To determine the mOS post-operative patients with pancreatic cancer

Secondary Outcome Measures

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

Quality of Life Assessment

safety profile

Treatment-emergent adverse events, drug-related adverse events will be analysed by 3 groups

Disease control rate(DCR)

Full Information

NCT ID

NCT03278015

First Posted

September 8, 2017

Last Updated

September 8, 2017

Sponsor

Chinese PLA General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03278015

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2017 (Anticipated)

Primary Completion Date

March 31, 2018 (Anticipated)

Study Completion Date

September 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer of Pancreas

Keywords

S-1, nab-paclitaxel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nab-paclitaxel plus Gemcitabine

Arm Type

Experimental

Arm Description

Arm Title

Gemcitabine monotherapy

Arm Type

Experimental

Arm Description

Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.

Arm Title

S-1 monotherapy

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Nab-paclitaxel plus Gemcitabine

Other Intervention Name(s)

nab-paclitaxel abraxane ABI-007, GEMXAR

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Gemcitabine monotherapy

Other Intervention Name(s)

GEMXAR

Intervention Description

Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.

Intervention Type

Drug

Intervention Name(s)

S-1 monotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Disease free survival(DFS)

Description

To determine the DFS of post-operative patients with pancreatic cancer

Time Frame

3 years

Title

overall survival time (OS)

Description

To determine the OS post-operative patients with pancreatic cancer

Time Frame

5 years

Title

median overall survival time (mOS)

Description

To determine the mOS post-operative patients with pancreatic cancer

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Objective Response Rate(ORR)

Description

All patients must be considered in response analysis, including those who discontinue treatment or who die for any reason prior to response evaluations

Time Frame

3 years

Title

Quality of Life Assessment

Time Frame

3 years

Title

safety profile

Description

Treatment-emergent adverse events, drug-related adverse events will be analysed by 3 groups

Time Frame

3 years

Title

Disease control rate(DCR)

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed-consent form. Man or woman aged 18 years to 80 years. Histologically confirmed pancreatic carcinoma, and the histological type is ductal adenocarcinoma. 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. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3, with life expectation of no less than 12 weeks. 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. Albumin ≥ 30 g/L. 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. Females of childbearing potential must have a negative serum pregnancy test and must not breast-feed before the first dose. Male also need contraception. Willing and able to comply with study procedures for the duration of the study. Exclusion Criteria: Hypertension, and unable to drop to normal level (systolic pressure >140 mmHg, diastolic pressure >90 mmHg) after treatment. Patients have active cardiac disease including any of the following: In resting state, average correction QTc > 470 msec on mean value of 3 times screening ECGs. 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. Any factors may increase the risk of QTc prolongation or arrhythmic event. Left ventricular ejection fraction (LVEF) < 50%. Patient weight still in losing period. 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. Patients with abdominal fistula, gastrointestinal perforation or abdominal abscess within the past 28 days, should not enter the trial. 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. 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. Uncontrollable nausea, vomit, chronic gastrointestinal disorders leading to unable to swallow drugs, which may affect the fully absorption of S-1. Patients with mental illness, or with psychiatric history of drug abuse.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dabin Xu, M.D.

Phone

8613522065659

xdabin@126.com

Facility Information:

Facility Name

Chinese PLA General Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

12. IPD Sharing Statement

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

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