A Trial of CMNa Combined With Definitive Concurrent Chemoradiotherapy for Locally Advanced ESCC

• Status: Completed
• Trial end date: 2018-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Cancer Hospital and Institute

Criteria

Inclusion Criteria:

1. Signed written informed consent prior to study entry

2. Patients with ESCC in upper and middle thoracic segment（stage II-III）confirmed by imaging and pathology or cytology, which is unsuitable or refuse surgery;

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: ANCcount ≥1500/mm3;platelet count ≥100,000/ mm3,hemoglobin≥9g/dl

9. normal hepatic funcion: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

11. normal cardiac function

12. Subjects tumor tissue available for the relevant biomarker detection

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. Primary lesions were multifocal

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

11. Significant disease which, in the investigator's opinion, would exclude the patient from the study