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A Trial of CMNa Combined With Concurrent Chemoradiotherapy for Locally Recurrent ESCC | Clinical Trials | Clareo Health

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A Trial of CMNa Combined With Concurrent Chemoradiotherapy for Locally Recurrent ESCC

A Perspective Trial of Sodium Glycididazole Combined With Concurrent Chemoradiotherapy for Locally Recurrent Squamous Cell Esophageal Carcinoma

NCT02721576•Shandong Cancer Hospital and Institute

View on ClinicalTrials.gov

Summary

This is a perspective, multicenter,single arm, open study to evaluate the efficacy and safety of treatment with CMNa combined with concurrent chemoradiotherapy in patients with locally recurrent squamous cell esophageal carcinoma . Analyses of primary objective (ORR) will be done as defined in the protocol.

Detailed Description

The primary end point of this study is objective response rate.The secondary end point is OS, PFS and the safety of drug. The primary hypothesis is the CMNa will improve ORR and thus improve OS, PFS. Assuming bilateral a=0.05, statistical power of 80%. The total sample size is 40 cases.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed written informed consent prior to study entry
•2. Patients with recurrent ESCC after radiotherapy, confirmed by imaging and pathology or cytology;
•3. Capable for chemo-radiotherapy;
•4. The existence of measurable lesions;
•5. ECOG PS of 0 or 1
•6. Possible semi-liquid diet;
•7. Expected lifetime≥3 months
•8. normal bone marrow reserve: ANC count ≥1500/mm3;platelet count ≥100,000/ mm3,hemoglobin≥9g/dl
•9. normal hepatic function:bilirubin level ≤1.5×ULN;AST/ALT≤1.5×ULN
•10. normal renal function: serum creatinine≤1.5mg/dl and calculated creatinine clearance ≥60ml/min
+3 more criteria

Exclusion Criteria

•1. Female subject who is during pregnancy or lactation, and the subject who have fertility don't take effective contraception during study
•2. Any mental illness or nervous system lesions or can't tell treatment response clearly (such as cerebrovascular accident sequelae)
•3. Any serious uncontrolled disease and infection, such as severe heart, liver, kidney diseases or diabetes, can't complete the treatment plan
•4. Patients who have other malignant lesions, except curable skin cancer (non-melanoma skin cancer),carcinoma in situ of cervix or serve disease cured for 5 years
•5. Patients with distant metastasis.
•6. Patients who have obvious esophageal ulcers or have above moderate pains in chest-back or have symptoms of esophageal perforation
•7. received anti-cancer treatment of esophageal cancer before the group, including surgery, radiotherapy, chemotherapy (induction of chemotherapy before the group is greater than or equal to two cycles)
•8. Not esophageal squamous carcinoma confirmed by pathology or cytology
•9. History of active hepatitis
•10. Unable to comprehend the study requirement or who are not likely to comply with the study requirements
+1 more criteria

Locations (9)

Qianfoshan Hospital of Shandong

Jinan, Shandong, China

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

Jining NO.1 People's Hospital

Jining, Shandong, China

Liaocheng People Hospital

Liaocheng, Shandong, China

Qingdao Center Medical Group

Qingdao, Shandong, China

Rizhao City People 's Hospital

Rizhao, Shandong, China

Fei Cheng People's Hospital

Tai’an, Shandong, China

An Qiu People's Hospital

Weifang, Shandong, China

The Fourth People's Hospitalof Zibo

Zibo, Shandong, China

Key Dates

Start Date

July 5, 2016

Primary Completion Date

June 30, 2018

Completion Date

July 30, 2018

Last Updated

October 11, 2019

Enrollment

ACTUAL participants

Conditions

Esophageal Neoplasms

Interventions

Sodium Glycididazole

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 11, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Trial of CMNa Combined With Concurrent Chemoradiotherapy for Locally Recurrent ESCC

Inclusion Criteria

Exclusion Criteria

Diagnosis of Multiple Cancer and Monitoring of Minimal Residual Tumors After Treatment Using Blood and High-Sensitivity Genetic Analysis Techniques

Barrett's Esophagus and Esophageal Adenocarcinoma, Searching for Reliable Diagnostic RNA Plasma-based Biomarkers

Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer.

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A Liquid Biopsy for High-risk Pre-cancer Screening of Esophageal Adenocarcinoma

KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method)