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Trial record 30 of 853 for:    Pancreatic Cancer AND Metastatic Pancreatic Cancer

A One-Arm Exploratory Clinical Trial of Apatinib Plus Gemcitabine in Patients With Advanced Metastatic Pancreatic Cancer (OECTAPGAMPC)

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ClinicalTrials.gov Identifier: NCT02863367
Recruitment Status : Unknown
Verified July 2016 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 11, 2016
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

Brief Summary:
Evaluate the efficacy and safety of Apatinib (500mg/d) with gemcitabine(1000mg/m2) in advanced metastatic pancreatic cancer.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: Apatinib Drug: Gemcitabine Phase 2

Detailed Description:

This test is a single center, one-armed exploratory clinical research, aimed at the evaluation the efficacy and safety of Apatinib with Gemcitabine in the patients with advanced metastatic pancreatic cancer.

This study plan in Tianjin Medical University Cancer Institute and Hospital.From launched in July 2016, this research intends to recruit the end time about as of December 2017, is expected to the end of the test time is in December 2017.

If do not have the appearance of the following circumstances, such as the subjects out of informed consent, drug toxicity tolerance or the researchers think that do not fit for further test, each subject research and treatment time is expected until imaging of tumor progression.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A One-Arm Exploratory Clinical Trial of Apatinib Plus Gemcitabine in Patients With Advanced Metastatic Pancreatic Cancer
Study Start Date : August 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment group
Apatinib:500 mg,po,qd, d1-14, every 3 week Gemcitabine:1000mg/m²,vein input 30-40,d1,d8,every 3 week
Drug: Apatinib
Apatinib:500 mg,po,qd, d1-14, every 3 week
Other Name: YN968D1

Drug: Gemcitabine
Gemcitabine:1000mg/m²,vein input 30-40,d1,d8,every 3 week




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 1 years ]

Secondary Outcome Measures :
  1. progression-free survival (PFS) [ Time Frame: 1 years ]
  2. Overall Survival (OS) [ Time Frame: 1 years ]
  3. Life Quality Score (QoL) [ Time Frame: 1 years ]
  4. Disease Control Rate (DCR) [ Time Frame: 1 years ]
  5. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age of patients ranges from 18 to 75 years old.
  2. Histologically or cytologic confirmed advanced metastatic pancreatic cancer (Exclusion of islet cell tumor ) .
  3. Must not received radiotherapy, chemotherapy or experimental treatment for advanced metastatic pancreatic cancer. Transfer of postoperative recurrence of patients with advanced pancreatic cancer can also be into the group.
  4. Karnofsky Performance Status Scale (KPS) ≥70.
  5. The first confirmed date of advanced metastatic pancreatic cancer not more than 6 weeks before starting treatment.
  6. No jaundice symptoms. Obviously abdominal water or have symptoms, need a drainage in advance. Don't need to adjust the analgesic therapy.
  7. Adequate hematologic functions :Hemoglobin (HGB) ≥ 90g/dL, Platelets (PLT) ≥ 100×10^9/L, the absolute number of Neutrophil (ANC) ≥ 1.5×10^9/L.
  8. Adequate hepatic, renal, heart functions :Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×the upper limit of normal (ULN).If liver metastases, AST and ALT ≤5.0×the ULN. Total bilirubin within the ULN. Serum Creatinine within the ULN, or creatinine clearance ≥ 60 mL/min.
  9. Blood coagulation test results: Prothrombin Time (PT) and Partial Thromboplastin Time (PPT) within ±15% of the normal.
  10. No clinically significant abnormal urine analysis results.
  11. Women with pregnancy or lactation, or fertility but during treatment and 6 months after treatment of termination unwilling or unable to use effective contraception to avoid pregnancy patients with male or female
  12. Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
  13. Patient consent and well compliance, scheduled to accept the visits, treatment, laboratory tests and other study procedures

Exclusion Criteria:

  1. Patients with the known brain metastases.
  2. Patients with locally advanced disease only.
  3. Decline in serum albumin (ALB) ≥ 20% from the screening visit to cycle 1 day 1 prior to the 72 hours.
  4. Over the past five years has a history of malignant tumors (including chronic leukemia). Patients with carcinoma in situ or basal cell carcinoma or squamous cell skin cancer can be selected.
  5. With need of systemic treatment activity, unable to control bacterial, viral or fungal infections
  6. Known HIV infection, or active hepatitis B or hepatitis C virus (HCV) infection.
  7. A major surgery (not include the diagnostic surgery) not more than 4 weeks before starting treatment.
  8. In the period of 6 months before starting treatment, Patients with myocardial infarction, severe or unstable angina, coronary artery and peripheral artery bypass grafting, New York heart association (NYHA) three - four level cardiac failure, out of control of high blood pressure, Patients with clinical significance of arrhythmia or abnormal electrocardiogram (ECG), cerebrovascular accident, transient ischemic attack, epilepsy, or with clinical significance of arrhythmia or a history of abnormal electrocardiogram (ECG).
  9. Has any study drug or its accessories history of allergies or allergic reactions, or patients showed this product or controlled drug prescribing information "contraindications or special warnings and precautions" section Outlines of events.
  10. The history of connective tissue disease (such as lupus, scleroderma, nodular arteritis).
  11. Has a history of interstitial pneumonia, slowly progressive dyspnea and cough, sarcoidosis, and silicosis, idiopathic pulmonary fibrosis, hypersensitivity pneumonitis, or a variety of allergies.
  12. Could damage patient safety or the integrity of the data to any situation, including severe medical risk factors, medical events and laboratory abnormalities or mental illness;
  13. Enter any other clinical study, some involved in drug test, or may interfere with the study in the program evaluation;
  14. The patient is not willing to or cannot meet research program, or plans for vacation during the research and treatment more than 7 days or seven days;
  15. The investigator think that the person doesn't fit into the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863367


Contacts
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Contact: Hao Ji Hui, PhD 022-23340123 ext 3070 renhe@tjmuch.com
Contact: Ren He, PhD 022-23340123 ext 3070 renhe@tjmuch.com

Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
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Principal Investigator: Hao Ji Hui, PhD National Clinical Research Center for Cancer of China

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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT02863367     History of Changes
Other Study ID Numbers: AHEAD-HBP001
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Apatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors