A Phase 2 interventional study of Radiation therapy and Thymalfasin in Colorectal Cancer, Metastatic Colorectal Cancer and Thymalfasin, sponsored by Zhejiang Provincial People's Hospital. Withdrawn. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Zhejiang Provincial People's Hospital · Phase 2, Interventional, and Treatment
Patients with colorectal cancer that had metastatic lesions after been treated with definitive surgery or chemoradiotherapy are being asked to participate in this study.
This study will help find out what abscopal effects (good or bad) the combination of radiotherapy and thymalfasin has on metastatic esophageal cancer.
Eligible are patients with metastatic colorectal 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.
5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
Browse Colorectal Neoplasms studies →Zhejiang Provincial People's Hospital is the lead sponsor of 60 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with metastatic lesions of colorectal cancer receiving single-agent chemotherapy will receive 3.5 Gy/fraction to a total dose of 35 Gy/10 fractions over 2 weeks with concurrent systemic therapy; Systemic agents are either capecitabine (Xeloda), paclitaxel or S-1;
Radiation: Radiation therapy · Drug: Thymalfasin
3.5Gy per fraction to a total dose of 35Gy/10 fractions over 2 weeks with concurrent thymalfasin for metastatic lesions of colorectal cancer.
Patients with metastatic lesions of colorectal cancer receiving 3.5Gy per fraction to a total dose of 35Gy/10 fractions over 2 weeks with concurrent thymalfasin ( given twice a week with an interval of 3-4 days each week).
Also known as: ZADAXIN's®
The proportion of patients with an abscopal response assessed at 7-8 weeks after the initiation of treatment.
Time frame: week 7- week 8
The number of participants with adverse events from the date of enrollment until 2 years from the opening of the study.
Time frame: year 0- year 2
The proportion of patients alive with abscopal responses from the date of enrollment until date of death from any cause, assessed up to 2 years from the opening of the study.
Time frame: year 0- year 2
No study locations are listed for this record.
This study is withdrawn, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Zhejiang Provincial People's Hospital