Hepatic RFA Increases T Cell Infiltraion and PD-L1 Expression in Primary Colorecatl Cancer

NCT02475889 | Completed

• 1 other identifier: RFAOO2
• Study Type: observational
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

It has been shown that RFA induced systemic tumor antigen-specific T cell responses in human carcinoma. However, there are insufficient studies on the immune modulation of tumor microenviroment (TME) outside of the ablation zone. In order to study how RFA modifies TME in human cancer patients, investigators performed a retrospective study of a unique cohort of patients who suffered from synchronous CRCLM.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Number of T cell infiltraion in primary tumor

  Number of T cell infiltraion in primary tumor was evaluated by immunohistochemical staining

  2 weeks

• PD-L1 expression in primary tumor

  PD-L1 expression in primary tumor was evaluated by immunohistochemical staining

  2 weeks

Study Arms (2)

RFA group

patients who received hepatic RFA followed by primary tumor resection were assigned to the RFA group

Procedure: Hepatic RFA; Procedure: Primary tumor resection

Non-RFA group

patients who received initial primary tumor resection without RFA

Procedure: Primary tumor resection

Interventions

Hepatic RFA PROCEDURE

Hepatic RFA was performed under guidace of ultrasonography (US) or computed tomography (CT) before primary tumor resection.

RFA group

Primary tumor resection PROCEDURE

Primary tumor resection were performed pre- or post-RFA for liver metastases.

Non-RFA group; RFA group

Eligibility Criteria

• Age: 32 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 391 consecutive patients with synchronous colorectal cancer liver metastases were initially included in this study. Among of them, 38 patients who received initial hepatic RFA followed by primary tumor resection were identified as RFA group, and the other 40 patients who received initial primary tumor resection were identified as Non-RFA group.

You may qualify if:

• Patients with histologically confirmed asynchronous liver metastases received initial hepatic RFA or initial primary tumor resection.

You may not qualify if:

• Preoperative CT, RT and other antitumor treatment
• Emergency surgery
• Initial hepatectomy
• No qualified endoscopic biopsy

Sponsors & Collaborators

• The First People's Hospital of Changzhou: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Paraffin-embedded tissues of endoscopic biopsy specimen and matched resected primary tumor specimen

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Changping Wu, M.D.

  The First People's Hospital of Changzhou

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 6, 2015
• First Posted: June 19, 2015
• Study Start: November 1, 2007
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: June 19, 2015

Record last verified: 2015-06