A Study of Comparing Huachansu Plus Thoracic RT Versus RT Alone For ESCC

NCT02647125 | Completed Phase 2 DMC

• 1 other identifier: ESO-Shanghai3
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Local control rate

  The outcome measure will be assessed by every 3-month follow-up examinations.

  the date of randomization until progression inside the irradiation field, up to 3 years.

Secondary Outcomes (2)

• overall survival

  the date of randomization until the death or the last follow up of the patients, up to 3 years.

• progress-free survival

  the date of randomization until progression or death from any cause, up to 3 years

Study Arms (2)

Huachansu Arm

EXPERIMENTAL

Patients in this arm will receive a treatment of Huachansu combined with thoracic radiotherapy.

Drug: Huachansu; Radiation: thoracic radiation

Control Arm

ACTIVE COMPARATOR

Patients in this arm will receive thoracic radiotherapy alone.

Radiation: thoracic radiation

Interventions

Huachansu DRUG

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

Huachansu Arm

thoracic radiation 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.

Control Arm; Huachansu Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Joined the study voluntarily and signed informed consent form.
• Age \>75 or age 18-75 who are intolerant of or reject intravenous chemotherapy.
• Both genders.
• Esophageal squamous cell carcinoma confirmed by pathology.
• Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a,TxN1M0-1a,TxNxM1a, AJCC 6th).
• No radiotherapy, chemotherapy or other treatments prior to enrollment.
• PS ECOG 0-2，wight loss\<30% during the latest 6 months.
• Life expectancy of more than 3 months.
• 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.
• No immuno-deficiency
• No heart diseases that need cardiac glycoside
• Use of an effective contraceptive for adults to prevent pregnancy.

You may not qualify if:

• Complete esophageal obstruction.
• Deep esophageal ulcer.
• Esophageal perforation.
• Haematemesis.
• After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy.
• Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years.
• Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives.
• Drug addiction,Alcoholism or AIDS.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan Universtiy Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• Liu 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 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

huachansu

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2015
• First Posted: January 6, 2016
• Study Start: September 1, 2015
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)