Detection of Circulating Tumor Tells as The Guidance of the Neoadjuvant Chemotherapy of Esophageal Cancer

Summary

Esophageal carcinoma is a common digestive system tumor, with number of deaths ranking No. 4 in malignant tumors. Esophageal squamous cell carcinoma in stage Ⅱ, III is the most common in China. The esophageal cancer during these stages is no longer localized lesions, and cancer will be transferred to other organs of the body through blood transmission, leading to tumor metastasis, which is the main cause of the patients' death. The tumor cells invade the surrounding tissues of primary tumor cells and enter the blood and lymphatic system, thus the circulating tumor cells (CTC) is formed and transported to a distal tissue, then effusing, adapting to the new microenvironment and finally forming metastases through the process of seeding, proliferation and colonization.

Recently, the controversy of surgical treatment of esophageal carcinoma is concentrated on the neoadjuvant therapy during perioperative period. NCCN guideline of 2015 recommended that patients with esophageal squamous cell carcinoma in T1b, N + and T2-T4a, N0-N + may consider preoperative neoadjuvant therapy, but its supporting literature (David Cunningham 2006, Marc Ychou 2011 and P. van Hagen, 2013) includes patients with pathology of the type adenocarcinoma. The esophageal cancer treatment guidelines of Japan 2015 adopted the opinion of NCCN Guidelines, and recommended neoadjuvant chemotherapy and radical surgery as the standard treatment for stage II and III esophageal cancer patients based on the results of randomized controlled clinical trial JCOG9907. However, the guidelines also pointed out that the role of neoadjuvant chemotherapy for resectable T1-3N0-1M0 cancers remains unclear according to the results of some meta-analysis.

The investigators choose the detection of peripheral venous blood CTCs and the disease-free survival as the main index, to compare the treatment effect of patients, those received neoadjuvant therapy, surgery and those received directly surgery, postoperative chemotherapy with esophageal squamous cell carcinoma in stage Ⅱ, III by means of evidence-based medicine; Define the indication of neoadjuvant chemotherapy in the treatment of esophageal squamous cell carcinoma in stage Ⅱ, III; Draft the solution to evaluate the treatment effect of neoadjuvant chemotherapy to esophageal cancer in stage Ⅱ, III, and the indication of neoadjuvant chemotherapy by test the peripheral venous blood CTCs and join the Chinese clinical guideline.

Conditions

• Esophageal Cancer TNM Staging Primary Tumor (T) T3

Interventions

PROCEDURE

chemotherapy

chemotherapy before surgery

PROCEDURE

Surgery

chemotherapy after surgery

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute

  collaborator OTHER

• Wuhan YZY Medical Science and Technology Co., Ltd.

  collaborator UNKNOWN

• The Second Hospital of Shandong University

  lead OTHER

Principal Investigators

• Xiaogang Zhao, Doctor · The Second Hospital of Shandong University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-31

Primary Completion

2018-12-31

Completion

2019-12-31

Countries

• China

Study Locations