Translational Research in Identifying Molecular Mechanisms for Rectal Cancer Metastasis

• Conditions: Rectal Cancer; Chemoradiation

• Registration Number: NCT02979795
• Lead Sponsor: China Medical University Hospital

Brief Summary

Rectal cancer, comprised of 30% of overall colorectal cancer cohort, is one of the leading cancers of Taiwan. In patients with advanced disease, the standard of care is concurrent chemoradiotherapy (CCRT) before surgery. After CCRT, the abscopal effect, a phenomenon that localized radiation not only destroys local tumor but also inhibits the growth of tumor at the remote site, has been observed. This effect is believed to be associated with tumor immune response. In addition, other immune checkpoint molecules, such as Programmed cell death-1(PD-1), Programmed cell death ligand-1 (PD-L1), and Cytotoxic T-Lymphocyte Associated Protein 4 (CTLA-4), have been reported associated with therapeutic outcome. However, after CCRT, more than 50% of patients were still either having persistent disease or developed distant metastasis. To improve therapeutic outcome of patients with rectal cancer, this project, thus, aims at exploring the evolution of factors that may affect the abscopal effect and immune checkpoint functions in tissues and in blood before and after CCRT.

Detailed Description

For most patients, preoperative chemoradiotherapy results in clinically tumor regression, but the degree of response varies among patients. There are approximately 40-60% of LARC patients treated with CCRT achieve some degree of pathologic response. However, there is yet an effective method before the commencement of CCRT that can predict how patients will respond to CCRT and can subsequently render better survival. Identify patents who will benefit most from CCRT is crucial not only in lowering treatment-related morbidity and sustaining local control but also to improve survival rate in LARC.

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-30
• Study First Submitted QC: 2016-11-30
• Last Update Submitted: 2016-11-30
• Study First Posted: 2016-12-02
• Last Update Posted: 2016-12-02
• Primary Completion: 2020-11
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Rectal cancer patients in China Medical University Hospital (Age limit: 20 yrs and older)

Exclusion Criteria

• Pregnancy, Disabilities

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor regression rate	within 8 weeks after completion of chemoradiotherapy	complete tumor regression rate(TRG) with tumor regression graded at at surgical resection at 8 weeks after completion of chemoradiotherapy

Secondary Outcome Measures

Name	Time	Method
Disease free survival	5 year
Overall survival	5 year
Local recurrence	5 year
Distant metastasis	5 year

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan