Apatinib as Second-line Treatment of Advanced Pancreatic Cancer

NCT02726854 | Unknown Phase 2

• 1 other identifier: XJTU1AF-CRF-2015-024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (2)

• PFS(Progression free survival)

  8 Weeks

• ORR (Objective response rate)

  8 Weeks

Secondary Outcomes (4)

• DCR(disease control rate)

  8 Weeks

• OS (Overall survival)

  8 Weeks

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

  8 Weeks

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

  8 Weeks

Study Arms (1)

Apatinib

EXPERIMENTAL

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

Drug: Apatinib

Interventions

Apatinib DRUG

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

Apatinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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;

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First affiliate hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Enxiao Li, MD

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

Danfeng Dong, MD

CONTACT

008615349257340; qiwudanfeng@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: April 4, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 2, 2016

Record last verified: 2016-11

Locations

CN (1)