AzTrials
AzTrials

Esophageal Squamous Cell CarcinomaPhase 2NCT02647125

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

A Phase 2 study testing Huachansu and thoracic radiation in people with Esophageal Squamous Cell Carcinoma, run by Fudan University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Huachansu and thoracic radiation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteChina
Study dates
Sep 2015to Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan Universtiy Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: A Phase II Study of Comparing Huachansu Combination With Thoracic Radiotherapy Versus Radiotherapy Alone For Esophageal Squamous Cell Carcinoma

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.

Being tested
Huachansu, thoracic radiation
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HuachansuDrug

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

  • thoracic radiationRadiation

    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 groups in NCT02647125
Study groupRoleWhat they receive
Huachansu ArmExperimentalPatients in this arm will receive a treatment of Huachansu combined with thoracic radiotherapy.
Receives: Drug: Huachansu; Radiation: thoracic radiation
Control ArmActive comparatorPatients in this arm will receive thoracic radiotherapy alone.
Receives: Radiation: thoracic radiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local control rate

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

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

Secondary outcomes (2)

  1. overall survival

    The survival time from date of randomization to the day of death or the last follow-up.

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

  2. progress-free survival

    Measured from date of randomization until progression or death from any cause

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2016 (estimated)
  2. Study startSep 2015
  3. Primary completionSep 2022
  4. Study completionDec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02647125
Sponsor's protocol ID
ESO-Shanghai3
Status last verified
Nov 2024
First submitted
12 Dec 2015
Last updated
26 Nov 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 41021440

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Huachansu and thoracic radiation in people with Esophageal Squamous Cell Carcinoma, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local control rate (time frame: the date of randomization until progression inside the irradiation field, up to 3 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02647125, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in