Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Thymalfasin

Adjuvants, Immunologic

Immunologic Factors

Patients with metastatic lesions of Non-small cell lung cancer receiving 3.5Gy per fraction to a total dose of 35Gy/10 fractions over 2 weeks with concurrent thymalfasin;

Metastatic lesions of Non-small cell lung cancer receiving 3.5Gy per fraction to a total dose of 35Gy/10 fractions over 2 weeks with concurrent thymalfasin.

Radiotherapy

Metastatic lesions of Non-small cell lung cancer receiving 3.5Gy per fraction to a total dose of 35Gy/10 fractions over 2 weeks with concurrent thymalfasin; Thymalfasin treatment is given twice a week with an interval of 3-4 days each week.

Shuqiang Wu, MD

Yongshi Jia, MD

Patients with Non-small cell lung 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 outside the radiation field (abscopal effect) after chemoradiotherapy of a metastatic site in metastatic Non-small cell lung cancer patients.
2. To induce the efficacy (effectiveness) of a new combination of therapy, chemoradiotherapy and thymalfasin for heavily pretreated, metastatic Non-small cell lung cancer patients;
3. To explore the role of PET/CT scanning to assess tumor response/abscopal effect.

This study will help find out what abscopal effects (good or bad) the combination of radiotherapy and thymalfasin has on metastatic Non-small cell lung cancer.

1. To observe immunity-mediated tumor response outside the radiation field (abscopal effect) after chemoradiotherapy of a metastatic site in metastatic Non-small cell lung cancer patients.
2. To induce the efficacy (effectiveness) of a new combination of therapy, chemoradiotherapy and thymalfasin for heavily pretreated, metastatic Non-small cell lung cancer patients;
3. To explore the role of PET/CT scanning to assess tumor response/abscopal effect.

Eligible are patients with metastatic Non-small cell lung cancer who have achieved stable disease or have disease progression after systemic therapy (surgery or definitive chemoradiotherapy) and have at least three separate 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, 35Gy in 10 fractions over a two week interval, conformally to maximally spare normal tissue or organ. Thymalfasin treatment is given twice a week with an interval of 3-4 days each week. At day 22 radiation is re-started and the same radiation dose is delivered to a second metastatic site, again with thymalfasin. Abscopal response is evaluated by assessing clinical and PET/CT response in the non-irradiated 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 abscopal responses, the trial will be terminated. If there are one or more abscopal responses in Stage One, the trial will proceed to enroll an additional 19 patients.

Abscopal Effect for Metastatic Non-small Cell Lung Cancer.

A Phase II Study of Radiotherapy and ZADAXIN's® (Thymalfasin) Induced Abscopal Effect in Patients With Heavily Pretreated, Metastatic Non-small Cell Lung Cancer.

Zhejiang Provincial People's Hospital

Digestive System Diseases

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

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.

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.

Stereotactic Body Radiation Therapy

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.

Shixiu Wu, MD

Tao Song, MD

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.

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.

SBRT Combined With Thymalfasin for Metastatic Esophageal Cancer

A Phase II Study of Stereotactic Body Radiation Therapy and ZADAXIN's® (Thymalfasin) Induced Tumor Effects in Patients With Heavily Pretreated, Metastatic Esophageal Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Abscopal Effect for Metastatic Non-small Cell Lung Cancer.	NCT02542930	Non-small Cell ... Metastatic Non-... Radiotherapy Thymalfasin	Radiotherapy Thymalfasin	19 Years -	Zhejiang Provincial People's Hospital
Abscopal Effect for Metastatic Non-small Cell Lung Cancer.	NCT02542930	Non-small Cell ... Metastatic Non-... Radiotherapy Thymalfasin	Radiotherapy Thymalfasin	19 Years -	Zhejiang Provincial People's Hospital
SBRT Combined With Thymalfasin for Metastatic Esophageal Cancer	NCT02545751	Esophageal Canc... Metastatic Esop... Stereotactic Bo... Thymalfasin	Stereotactic Bo... Thymalfasin	19 Years -	Hangzhou Cancer Hospital

Spots Global Cancer Trial Database for zadaxin's®

Every month we try and update this database with for zadaxin's® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for zadaxin's®

Every month we try and update this database with for zadaxin's® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for zadaxin's® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.