Clinical trial · Interventional
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
NCT02721576CI-TRIAL-00041111terminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The number of enrolled cases is too small.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sodium Glycididazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sodium Glycididazole
- description
- Sodium Glycididazole：800mg/m2，finished in 30 minutes,within 60 minutes after intravenous drip for radiation therapy.Three times a week (once every other one day),before radiation therapy. Chemotherapy Paclitaxel:45 mg/m²,d1,week 1-6 Cisplatin:20 mg/m²,d1,week 1-6 OR Docetaxel: 75 mg / m², 1 day or divided into D1, D8 days, 21 days / cycle. Cisplatin: 75 mg / m², divided into D1-D3 days or D1-D5 days, 21 days / cycle. Or nedaplatin: 80 mg / m², 21 days / cycle. OR 5-FU: 500 mg / m² / day, divided into D1 \~ D5 for use, 21 days / cycle. Cisplatin: 75 mg / m² / day, divided into D1-D3 day or D1-D5 days, 21 days / cycle. Or nedaplatin: 80 mg / m², 21 days / cycle 3DCRT/IMRT:2.0Gy/f/day,T\>40Gy/20f,week 1-\>5
- interventionNames
- Drug: Sodium Glycididazole
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- up to 3 month
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 11. Normal cardiac function 12. Subjects tumor tissue available for the relevant biomarker detection 13. Clinical stage: No distant metastasis 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 11. Significant disease which, in the investigator's opinion, would exclude the patient from the study
References
Publications (0)
Data not yet available
No reference posted for this study.