Clinical trial · Interventional
A Study of Comparing Huachansu Plus Thoracic RT Versus RT Alone For ESCC
A Phase II Study of Comparing Huachansu Combination With Thoracic Radiotherapy Versus Radiotherapy Alone For Esophageal Squamous Cell Carcinoma
NCT02647125CI-TRIAL-00083026completedPhase 2ClinicalTrials.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 primary objective of the trial is to study whether the local control of Huachansu plus thoracic radiotherapy is better compared to thoracic radiotherapy alone for patients with esophageal squamous cell carcinoma. It's a phase II study, 134 patients are expected to be recruited into the trial.
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 Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Huachansu | Drug | — | UNRESOLVED |
| thoracic radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Huachansu Arm
- description
- Patients in this arm will receive a treatment of Huachansu combined with thoracic radiotherapy.
- interventionNames
- Drug: Huachansu
- Radiation: thoracic radiation
- type
- ACTIVE_COMPARATOR
- label
- Control Arm
- description
- Patients in this arm will receive thoracic radiotherapy alone.
- interventionNames
- Radiation: thoracic radiation
Primary outcomes (1)
- measure
- Local control rate
- timeFrame
- the date of randomization until progression inside the irradiation field, up to 3 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Joined the study voluntarily and signed informed consent form. 2. Age \>75 or age 18-75 who are intolerant of or reject intravenous chemotherapy. 3. Both genders. 4. Esophageal squamous cell carcinoma confirmed by pathology. 5. Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a,TxN1M0-1a,TxNxM1a, AJCC 6th). 6. No radiotherapy, chemotherapy or other treatments prior to enrollment. 7. PS ECOG 0-2，wight loss\<30% during the latest 6 months. 8. Life expectancy of more than 3 months. 9. Hemoglobin（Hb）≥9 g/dL,WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L platelet count (Pt) ≥100x 109/L.Hepatic function: ALAT and ASAT \< 2.5 x ULN, TBIL\<1.5 x ULN.Renal function: creatinine \< 1.5 x ULN. 10. No immuno-deficiency 11. No heart diseases that need cardiac glycoside 12. Use of an effective contraceptive for adults to prevent pregnancy. Exclusion Criteria: 1. Complete esophageal obstruction. 2. Deep esophageal ulcer. 3. Esophageal perforation. 4. Haematemesis. 5. After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy. 6. Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years. 7. Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives. 8. Drug addiction,Alcoholism or AIDS.
References
Publications (1)
- DERIVEDLiu Q, Shen J, Chen Y, Zhou J, Luo H, Deng J, Ai D, Zhu H, Hao S, Zhao K. Phase II trial of radiotherapy plus Huachansu in elderly or chemotherapy-ineligible patients with locally advanced esophageal squamous cell carcinoma. Oncologist. 2025 Oct 1;30(10):oyaf325. doi: 10.1093/oncolo/oyaf325. PMID 41021440