Loading clinical trials...

UNKNOWNPHASE2

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

NCT02863367•Tianjin Medical University Cancer Institute and Hospital

Summary

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

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

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).
+5 more criteria

Key Dates

Start Date

August 1, 2016

Primary Completion Date

December 1, 2017

Completion Date

December 1, 2017

Last Updated

August 11, 2016

Enrollment

ESTIMATED participants

Conditions

Metastatic Pancreatic Cancer

Interventions

Apatinib

DRUG

Gemcitabine

DRUG

Contacts

Hao Ji Hui, PhD

CONTACT

022-23340123 renhe@tjmuch.com

Ren He, PhD

CONTACT

022-23340123 renhe@tjmuch.com

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

NCT07409272

Pancreatic CancerMetastatic Pancreatic Cancer+1 more

View study

RECRUITINGPHASE2

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

NCT05065801

Metastatic Pancreatic Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 11, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC

Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT as Second-line Therapy in Metastatic Pancreatic Cancer Patients

A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer

Irinotecan Hydrochloride Liposome Injection (II)in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Metastatic Pancreatic Cancer