SBRT Combined With Thymalfasin for Metastatic Esophageal Cancer

NCT02545751 | Unknown Phase 2

• 1 other identifier: Hangzhou CH
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with esophageal cancer that had metastatic lesions after been treated with definitive surgery or chemoradiotherapy are being asked to participate in this study.

1. 1.To observe immunity-mediated tumor response after Stereotactic Body Radiation Therapy(SBRT) of a metastatic site in metastatic esophageal cancer patients.
2. 2.To induce the efficacy (effectiveness) of a new combination of therapy, SBRT and thymalfasin for heavily pretreated, metastatic esophageal cancer patients; This study will help find out what effects (good or bad) the combination of radiotherapy and thymalfasin has on metastatic esophageal cancer.

Conditions

Esophageal Cancer; Metastatic Esophageal Cancer; Stereotactic Body Radiation Therapy; Thymalfasin

Keywords

Esophageal cancer; Metastatic esophageal cancer; Radiotherapy; Thymalfasin; ZADAXIN's®; Stereotactic Body Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with tumor responses after the initiation of treatment.

  month 1- month 6

Secondary Outcomes (2)

• The number of participants with adverse events from the date of enrollment until 2 years from the opening of the study.

  year 0- year 2

• The proportion of patients alive with tumor responses from the date of enrollment until date of death from any cause, assessed up to 2 years from the opening of the study.

  year 0- year 2

Study Arms (1)

SBRT and Thymalfasin arm

EXPERIMENTAL

SBRT is given during combined therapy to one of the lesions, 25Gy in 5 fractions over one week, conformally to maximally spare normal tissue or organ. Thymalfasin treatment is given twice a week with an interval of 3-4 days until tumor progression of other metastatic lesions. Tumor response is evaluated by assessing clinical and CT/MRI response for all the other measurable metastatic sites.

Radiation: Stereotactic Body Radiation Therapy; Drug: Thymalfasin

Interventions

Stereotactic Body Radiation Therapy RADIATION

SBRT is given during combined therapy to one of the metastatic lesions, 25Gy in 5 fractions (5Gy per fraction) over one week, conformally to maximally spare normal tissue or organ.

Also known as: SBRT

SBRT and Thymalfasin arm

Thymalfasin DRUG

Thymalfasin treatment is given twice a week with an interval of 3-4 days until progression of other metastatic lesions. Tumor response is evaluated by assessing clinical and CT/MRI response for all the other measurable metastatic sites.

Also known as: ZADAXIN's®

SBRT and Thymalfasin arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed esophageal cancer which is persistent and metastatic or recurrent and metastatic;
• Patients must have at least 2 distinct measurable metastatic sites at least 1 cm of larger in their largest diameter;
• Age ≥18 years;
• Metastatic disease measurable on a CT/MRI scan. The primary tumor is not considered measurable disease. Metastatic lesions within a prior radiation field are acceptable as long as disease has progressed in the radiation field by RECIST criteria. The same imaging modality performed at baseline (CT or MRI) will be repeated at subsequent imaging.
• ECOG performance status: 0-1;
• Life expectancy ≥ 3 months.
• Patients have adequate baseline organ and marrow function as defined by an absolute neutrophil count greater than 1500 cells per μL, platelet concentration of greater than 50 000 per μL, total bilirubin less than 1•5 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase less than 2•5 times the ULN, and serum creatinine less than 1•5 times the ULN;
• Signed consent forms voluntarily;

You may not qualify if:

• Patients undergoing therapy with other investigational agents.
• Women who are pregnant or breastfeeding;
• Patients with known brain metastases can be included in this clinical trial but brain lesions are not eligible as target or non target lesion;
• Anticipated patient survival under 3 months;
• Active severe infection or known chronic infection with HIV, hepatitis B virus, or hepatitis C virus;
• Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, myocardial infarction, stroke or congestive heart failure within the last 6 months;
• The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;
• Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;
• Patients with any other concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for participation in the study.

Sponsors & Collaborators

• Hangzhou Cancer Hospital: lead

Study Sites (1)

Hangzhou Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Radiosurgery; Thymalfasin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins

Study Officials

• Shixiu Wu, MD

  Hangzhou Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Shixiu Wu, MD

CONTACT

wushixiu@medmail.com.cn

Tao Song, MD

CONTACT

taosong01@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: September 10, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: November 28, 2017

Record last verified: 2017-11

Locations

CN (1)