Overview

Abscopal Effect for Metastatic Non-small Cell Lung Cancer.

Status:
Withdrawn
Trial end date:
2019-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Zhejiang Provincial People's Hospital
Zhejiang Provincial People’s Hospital
Treatments:
Thymalfasin
Criteria
Inclusion Criteria:

1. Patients with histologically confirmed colorectal cancer which is persistent and
metastatic or recurrent and metastatic;

2. Patients must have at least 3 distinct measurable metastatic sites at least 1 cm of
larger in their largest diameter;

3. Age ≥18 years;

4. 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.

5. ECOG performance status: 0-1;

6. Life expectancy ≥ 3 months.

7. 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;

8. Signed consent forms voluntarily;

Exclusion Criteria:

1. Patients who have had prior allergic reaction to Apatinib;

2. Patients undergoing therapy with other investigational agents.

3. Women who are pregnant or breastfeeding;

4. Patients with known brain metastases can be included in this clinical trial but brain
lesions are not eligible as target or non target lesion;

5. Anticipated patient survival under 3 months;

6. Active severe infection or known chronic infection with HIV, hepatitis B virus, or
hepatitis C virus;

7. Cardiovascular disease problems including unstable angina, therapy for
life-threatening ventricular arrhythmia, myocardial infarction, stroke or congestive
heart failure within the last 6 months;

8. 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;

9. 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;

10. Patients with any other concurrent disease which, in the judgment of the investigator,
would make the patient inappropriate for participation in the study.