Clinical trial · Interventional
A Trial of CMNa Combined With Definitive Concurrent Chemoradiotherapy for Locally Advanced ESCC
A Perspective Random Trial of Sodium Glycididazole Combined With Definitive Concurrent Chemoradiotherapy for Locally Advanced Squamous Cell Esophageal Carcinoma
NCT02721563CI-TRIAL-00041106completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Sodium Glycididazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- 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,T60Gy/30f,week 1-6
- interventionNames
- Drug: Sodium Glycididazole
- type
- PLACEBO_COMPARATOR
- label
- Control Group
- description
- Placebo：dissolved in 100mlphysiological saline(Now with chef),ivgtt,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, total 6 weeks course.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, 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,T60Gy/30f,week 1-6
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 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
References
Publications (1)
- DERIVEDLi X, Zhao H, Xie P, Zhu W, Liu L, Wu P, Sheng Y, Wang C, Song Y, Meng X, Zhang J, Xing L. Sodium glycididazole combined with definitive chemoradiotherapy for patients with esophageal squamous cell carcinoma: A multicenter randomized clinical trial. Precis Radiat Oncol. 2026 Feb 25;10(1):19-26. doi: 10.1002/pro6.70052. eCollection 2026 Mar. PMID 42022351