SBRT Combined With Thymalfasin for Metastatic Esophageal Cancer

Status Recruiting

Clinical Trial 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. To observe immunity-mediated tumor response after Stereotactic Body Radiation Therapy(SBRT) of a metastatic site in metastatic esophageal cancer patients.

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.

Clinical Trial Description

1. To observe immunity-mediated tumor response after Stereotactic Body Radiation Therapy(SBRT) of a metastatic site in metastatic esophageal cancer patients.

2. To induce the efficacy (effectiveness) of a new combination of therapy, SBRT and thymalfasin for heavily pretreated, metastatic esophageal cancer patients; Eligible are patients with metastatic esphageal cancer who have achieved stable disease or have disease progression after systemic therapy (surgery or definitive chemoradiotherapy) and have at least two measurable sites of metastatic lesions. Extent of metastatic disease is recorded both at CT and PET/CT scanning. Radiation is given during combined therapy to one of the lesions, 25Gy in 5 fractions over one week interval with SBRT, conformally to maximally spare normal tissue or organ. Thymalfasin treatment is given twice a week with an interval of 3-4 days each week for a total of 8 weeks. Tumor response is evaluated by assessing clinical and CT/MRI response for all of the measurable metastatic sites. A Phase II clinical trial based on an optimum two-stage Phase II Simon design is used to conduct this pilot study. Ten patients will be treated in Stage one; if there are no tumor responses, the trial will be terminated. If there are one or more tumor responses in Stage One, the trial will proceed to enroll an additional 19 patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02545751
Study type	Interventional
Source	Hangzhou Cancer Hospital
Contact	Shixiu Wu, MD
Email	wushixiu@medmail.com.cn
Status	Recruiting
Phase	Phase 2
Start date	January 2016
Completion date	December 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06006390` - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors	Phase 1/Phase 2
Terminated	`NCT01624090` - Mithramycin for Lung, Esophagus, and Other Chest Cancers	Phase 2
Recruiting	`NCT05787522` - Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk
Not yet recruiting	`NCT05542680` - Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer	N/A
Completed	`NCT03384511` - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.	Phase 4
Completed	`NCT00003864` - Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus	Phase 2
Recruiting	`NCT05491616` - Nivolumab During Active Surveillance After Neoadjuvant Chemoradiation for Esophageal Cancer: SANO-3 Study	Phase 2
Active, not recruiting	`NCT04383210` - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors	Phase 2
Completed	`NCT00199849` - NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine	Phase 1
Completed	`NCT03756597` - PAN-study: Pan-Cancer Early Detection Study (PAN)
Completed	`NCT00400114` - Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer	Phase 2
Completed	`NCT03652077` - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies	Phase 1
Recruiting	`NCT04615806` - The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Esophagectomy	N/A
Active, not recruiting	`NCT04566367` - Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer	N/A
Active, not recruiting	`NCT03962179` - Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent)	N/A
Terminated	`NCT01446874` - Prevention of Post-operative Pneumonia (POPP)	Phase 2/Phase 3
Completed	`NCT03468634` - Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy	N/A
Active, not recruiting	`NCT02869217` - Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors	Phase 1
Completed	`NCT02810652` - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection	N/A
Recruiting	`NCT02544737` - Apatinib for Metastatic Esophageal Cancer.	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.