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Status unknownNCT02726854ApslpancUpdated Dec 2, 2016

Apatinib as Second-line Treatment of Advanced Pancreatic Cancer

A Phase 2 interventional study of Apatinib in Pancreatic Neoplasms, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-12-02.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
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Study summary

The main research purpose Evaluation of objective response Apatinib second-line treatment of advanced pancreatic cancer (ORR) and the rate of progression free survival (PFS).

Objective to study the objective and exploratory secondary research To observe the Apatinib in second line treatment of advanced pancreatic cancer disease control rate (DCR), patients with overall survival (OS) benefit, treatment effects on quality of life (QOL) score and drug safety evaluation, To investigate the relationship of apatinib as second-line treatment of advanced pancreatic cancer and the expression of vascular endothelial growth factor receptor(VEGFR) in the serum

Read the detailed description

The purpose of this study is to determine what effects apatinib has on advanced pancreatic cancer patients after failure of first-line chemotherapy cannot tolerate second-line chemotherapy or unwilling to receive second-line chemotherapy of pancreatic cancer patients.To investigate the relationship between apatinib as second-line treatment of advanced pancreatic cancer and the expression of vascular endothelial growth factor receptor(VEGFR) in the serum.

This study choose the First Affiliated Hospital of Xi'an JiaoTong University were unable to tolerate the failure of first-line chemotherapy for second-line chemotherapy or unwilling to receive second-line chemotherapy of pancreatic cancer patients as the research object, the clinical data of clinical subjects age and sex, Eastern Cooperative Oncology Group (ECOG) score, tumor stage, pathological type, pathological grading, giving apatinib treatment, during the treatment of blood monitoring in patients with CA199 levels, imaging findings, assessment of tumor related symptoms and adverse events, and the expression of VEGFR in blood was measured by ELISA method, the curative effect evaluation of the end of the 2 cycle of treatment, patients with effective evaluation to oral apatinib, through the statistical analysis of the data of complete remission (CR) or partial remission (PR), the rate of progression free survival (PFS) expression of CA199 content in serum and serum VEGFR levels of the relevant indicators,. Explore Apatinib for the curative effect and safety of the second-line treatment of advanced pancreatic cancer, and to explore the relationship between the serum VEGF expression level.

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Conditions studied

  • Pancreatic Neoplasms
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In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's planned enrollment of 30 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ≥ 18 and ≤ 70 years of age,Male or female;
  • The advanced pancreatic cancer pathology, with measurable lesions (spiral CT scan is more than 10mm, according to the standard of RECIST 1.1);
  • Locally advanced, unresectable recurrent or metastatic pancreatic cancer;
  • According to CTCAE 4.0 and patient complaints, the researchers determine second-line chemotherapy should not be tolerated by the patients or patients want to receive second-line chemotherapy.
  • ECOG performance scale 0-1;
  • Baseline blood routine and biochemical indexes meet the following criteria:
  • Hemoglobin ≥ 80g/L,
  • The absolute neutrophil count (ANC) ≥ 1.5 ×109/L,
  • Blood platelet ≥ 90 ×109/L
  • Alanine aminotransferase(ALT),Aspartate transaminase (AST) less than 2.5 times the upper limit of normal value, equal to or less than 5 times the upper limit of normal (liver metastasis),
  • the serum total bilirubin is less than 1.5 times the upper limit of normal value,
  • Serum creatinine. Less than 1.5 times the upper limit of normal value,
  • Serum albumin is more than 30g/L;
  • Life expectancy ≥ 3 months.
  • women of childbearing age to within 7 days before entering the group of serum or urine pregnancy test and the results were negative. And be willing to give drug test during the test and the last 8 weeks using an appropriate method of contraception. For men, for sterilization, or agreed to during the period of the experiment and at the end of the given experimental drugs for 8 weeks by appropriate methods of contraception;
  • In this study, volunteer subjects signed the informed consent, good compliance with follow-up.

Exclusion criteria

Exclusion Criteria:

  • It is confirmed that of apatinib and / or its accessories allergy;
  • Have high blood pressure and antihypertensive drug treatment can not drop to normal range(systolic pressure >140 mmHg, diastolic blood pressure 90>mmHg), suffering from coronary artery disease above grade I, grade I arrhythmia (including corrected QT interval prolongation male > 450 ms, women > 470 MS) and grade I heart insufficiency; urine protein positive patients.
  • Has a variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.);
  • Coagulant function abnormality (INR>1.5, activated partial thromboplastin time(APTT)>1.5, ULN) with bleeding tendency;
  • patients with central nervous system metastasis;
  • pregnant or lactating women;
  • Patients with other malignant tumors within five years;
  • Has a history of psychiatric drugs abuse and can't quit or patients with mental disorders;
  • 4 weeks participated in other clinical trials of patients;
  • received VEGFR inhibitors, such as sorafenib, chougny for treatment;
  • According to the researcher's judgment, there is serious to endanger the safety of patients or affect patients with disease to do the research;
  • The researchers think that the person doesn't fit into.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Apatinib

    Patients will be offered with Apatinib (850mg daily,orally)until their disease have progressed.

    Drug: Apatinib

Interventions

  • DrugApatinib

    Patients with pancreatic cancer who are failed of receiving first-line chemotherapy and cannot tolerate second-line chemotherapy or unwilling to receive second-line chemotherapy will receive Apatinib Tablets (850mg once daily, orally) 30 minutes after meal with warm water. Take 28 days as a cycle, patients will receive this treatment until they have got disease progressed.

    Also known as: YN968D1

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What researchers measure

Primary outcomes

  1. PFS(Progression free survival)

    Time frame: 8 Weeks

  2. ORR (Objective response rate)

    Time frame: 8 Weeks

Secondary outcomes

  1. DCR(disease control rate)

    Time frame: 8 Weeks

  2. OS (Overall survival)

    Time frame: 8 Weeks

  3. QoL (Quality of life as assessed by EORTC QLQ-C30)

    Time frame: 8 Weeks

  4. Number of participants with treatment-related adverse events as assessed by NCI-CTC(V3.0)

    Time frame: 8 Weeks

07

Study locations

1 of 1 sites recruiting
  • First affiliate hospital of Xi'an Jiaotong University
    Xi'an, Shaanxi 710061, China
    • · Contact · 2982655038
    • China · Contact · 2982655038
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02726854
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Responsible party
Sponsor
First posted
Apr 4, 2016
Start date
Apr 2016
Primary completion
Dec 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Dec 2, 2016

Study contacts

Danfeng Dong, MD
Contact
qiwudanfeng@sina.com
008615349257340
Enxiao Li, MD
study chair · First Affiliated Hospital Xi'an Jiaotong University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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