Radiofrequency Ablation Combined With S-1 for Pancreatic Cancer With Liver Metastasis

Carcinoma, Pancreatic Clinical Trial

Official title:

Radiofrequency Ablation Combined With S-1 for Pancreatic Cancer With Liver Metastasis: Correlation Analysis of Prognosis and microRNA Expression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02634502
• Other study ID #: RFA-2013
• Status: Recruiting
• Phase: Phase 2
• First received: December 16, 2015
• Last updated: December 17, 2015
• Start date: October 2013

Study information

• Verified date: December 2015
• Source: Fudan University
• Contact: Yehua Shen, MD, Ph D
• Phone: 86-21-64175590
• Email: yehuash25[@]163.com
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Interventional

Clinical Trial Summary

This study aims to explore the efficacy and safety of radiofrequency ablation combined with S-1 in pancreatic cancer patients with liver metastasis, as well as the correlation of serum microRNA and patients' prognosis. This protocol will be overseen by the Fudan University Institutional Review Board which has Federal Wide Assurance through the U.S. Department of Health & Human Services (Approved: April 25, 2002).

Description:

Primary Outcome Measures:

To evaluate the overall survival (OS) in pancreatic cancer patients with liver metastasis treated with radiofrequency ablation combined with S-1.

Secondary Outcome Measures:

1. To explore the correlation of OS and serum microRNA of the patients.

2. To evaluate the progression free survival (PFS) and its correlation with serum microRNA.

3. To observe the objective response rate (ORR) and adverse effects of the treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Karnofsky Performance Status = 70

• Histologically/cytologically confirmed pancreatic adenocarcinoma.

• Patients must have underwent radical resection of the pancreatic lesion, or have their locally advanced pancreatic lesion controlled after first-line chemotherapy.

• At least one measurable liver metastasis by RECIST criteria must be present.

• Single liver metastasis smaller than 5cm, or multiple liver metastases less than 6 lesions and smaller than 3cm for each, without metastasis to other sites.

• Patients must have adequate organ functions reflected by the laboratory criteria below:

Granulocytes = 2,000/uL, Hemoglobin = 8.0 gm/dL, Platelets = 100,000/uL, Serum creatinine < 2.0 mg/dL, Bilirubin < 1.5 mg/dL, SGPT < 2.5 x normal, prothrombin time <13.5s

• Prior therapy, e.g., chemotherapy, radiation, is allowed provided that at least 4 weeks washout time is given.

• Patients with jaundice must have a biliary drainage decompression operation before recruitment.

• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

• Prior treatment with S-1.

• Liver metastatic lesion is located at the surface of the liver, with more than 1/3 of the tumor protruding outside.

• Subject has Child-Pugh grade Class C hepatic impairment, massive ascites, active gastrointestinal bleeding, severe coagulation disorder that could not be corrected, or other contraindication for radiofrequency ablation.

• Tumor invasion of Cavity organs.

• Known central nervous system involvement and leptomeningeal disease.

• Concurrent infection requiring intravenous antibiotics.

• Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV), active HIV infection/HIV disease, psychiatric disorders.

• Subject has previous or concurrent cancer that is distinct in primary site or histology from pancreatic adenocarcinoma except cervical carcinoma in situ, non-melanoma carcinoma of the skin or in situ carcinoma of the bladder. Any cancer curatively treated greater than 3 years prior to entry is permitted.

• Pregnant or lactating women.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Pancreatic
• Pancreatic Neoplasms

Intervention

Procedure:
• radiofrequency ablation

Drug:
• S-1

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		From date of randomization until the date of death, assessed up to 100 months.	No
Secondary	Progression free survival		From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.	No