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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02647125

Enrollment

126

Registered

2016-01-06

Start date

2015-09-30

Completion date

2022-12-31

Last updated

2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Squamous Cell Carcinoma

Brief summary

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.

Interventions

DRUGHuachansu

Huachansu 20 ml/m2/d, intervenous infusion, once a day, 5 times per week, during the period of radiation.

RADIATIONthoracic radiation

A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Local control rate	the date of randomization until progression inside the irradiation field, up to 3 years.	The outcome measure will be assessed by every 3-month follow-up examinations.

Secondary

Measure	Time frame	Description
overall survival	the date of randomization until the death or the last follow up of the patients, up to 3 years.	The survival time from date of randomization to the day of death or the last follow-up.
progress-free survival	the date of randomization until progression or death from any cause, up to 3 years	Measured from date of randomization until progression or death from any cause

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026