Thoracic Esophageal Squamous Cell CarcinomaNCT04174079
Study on Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma
A study testing chemotherapy in people with Thoracic Esophageal Squamous Cell Carcinoma, run by Sun Yat-Sen University Cancer Center at 1 site in China.
Trial summary
Patients with thoracic esophageal squamous cell carcinoma after total two-field lymph node dissection were randomized into the adjuvant chemotherapy group or the postoperative observation group Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thoracic Esophageal Squamous Cell Carcinoma
- What is being tested?
- chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteChina
- Study dates
- 11 Dec 2019to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with esophageal squamous cell carcinoma who received radical surgical resection and total two-field lymph node dissection did not receive neoadjuvant therapy before surgery, and didn't suffer serious complications after surgery.
- T≥3 or N≥1, and more than 15 lymph nodes were dissected.
- Age ≥18 years and ≤75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Adequate hematological function:
- absolute neutrophil count (ANC) ≥ 1.5×109/L, and blood platelet count (PLT) ≥ 1.5×109/L, and hemoglobin ≥ 9g/dL.
Show all 10Show fewer
- Adequate hepatic function: total bilirubin ≤1.5 times the upper limit of normal (ULN), aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase ≤2.5 × ULN.
- Adequate renal function:
- serum creatinine ≤1.5 × ULN and creatinine clearance ≥50 ml/min.
- Subjects could understand and comply with study and follow-up procedures, and voluntarily signed written informed consent
Who cannot join
- Suffering from previous primary malignancy or co-existing serious illness of other organs, which will affect the judgment of the end point of this study.
- Serious postoperative complications that will affect progress of chemotherapy.
- Patients with chemotherapy contraindications.
- Women who are pregnant or breast-feeding or who are planning for pregnancy.
- Unable to complete the follow-up as planned.
- Without informed consent due to psychological, family, social and other factors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Uniersity Cancer Center
Guangzhou, Guangdong, 510060
Peng Lin, professor, +86-20-87343314, linpeng@sysucc.org.cn
Xing Ru Ping, +86-20-87343736, xingrp@sysucc.org.cn
About this study
Official title: A Prospective, Randomized Controlled Clinical Trial of Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma
Patients with thoracic esophageal squamous cell carcinoma after total two-field lymph node dissection were randomized into the adjuvant chemotherapy group or the postoperative observation group
Read the detailed description
Patients with T≥3 or N≥1 thoracic esophageal squamous cell carcinoma after total two-field lymph node dissection were randomly enrolled into the experimental group for adjuvant chemotherapy or the controlled group for postoperative observation. The experimental group received 4-course chemotherapy of docetaxel combined with nedaplatin, and to observe the 3-year progression free survival (DFS) and 5-year overall survival (OS) in two groups.
- Being tested
- chemotherapy
- Keywords
- adjuvant chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapyDrug
patients with R0 resected T≥3 or N≥1 thoracic esophageal squamous cell carcinoma began to receive chemotherapy of docetaxel combined with nedaplatin within 8 weeks after total two-field lymph node dissection. Docetaxel 75mg/m2 day 1, nedaplatin 75mg/m2 day 1, every 21 days for 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | patients with R0 resected T≥3 or N≥1 thoracic esophageal squamous cell carcinoma began to receive chemotherapy of docetaxel combined with nedaplatin within 8 weeks after total two-field lymph node dissection. Docetaxel 75mg/m2 day 1, nedaplatin 75mg/m2 day 1, every 21 days for 4 cycles Receives: Drug: chemotherapy |
| control group | No intervention | patients with R0 resected T≥3 or N≥1 thoracic esophageal squamous cell carcinoma were reviewed regularly after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Patients were images with computed tomography (CT) scan
Measured: At most 5 years after enrollment
Secondary outcomes (1)
overall survival
Patients were images with computed tomography (CT) scan
Measured: At most 5 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start11 Dec 2019
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen University Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Lin, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174079
- Sponsor's protocol ID
- B2019-061-01
- Status last verified
- Jul 2026
- First submitted
- 19 Nov 2019
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Clinical Trial of Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04174079
- Acronym / sponsor ID
- B2019-061-01
- Keywords
- adjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Sun Yat-Sen University Cancer CenterUniversity, hospital or other
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with thoracic esophageal squamous cell carcinoma after total two-field lymph node dissection were randomized into the adjuvant chemotherapy group or the postoperative observation group
Detailed description
Patients with T≥3 or N≥1 thoracic esophageal squamous cell carcinoma after total two-field lymph node dissection were randomly enrolled into the experimental group for adjuvant chemotherapy or the controlled group for postoperative observation. The experimental group received 4-course chemotherapy of docetaxel combined with nedaplatin, and to observe the 3-year progression free survival (DFS) and 5-year overall survival (OS) in two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: chemotherapypatients with R0 resected T≥3 or N≥1 thoracic esophageal squamous cell carcinoma began to receive chemotherapy of docetaxel combined with nedaplatin within 8 weeks after total two-field lymph node dissection. Docetaxel 75mg/m2 day 1, nedaplatin 75mg/m2 day 1, every 21 days for 4 cycles |
| control group | No intervention | –patients with R0 resected T≥3 or N≥1 thoracic esophageal squamous cell carcinoma were reviewed regularly after surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with esophageal squamous cell carcinoma who received radical surgical resection and total two-field lymph node dissection did not receive neoadjuvant therapy before surgery, and didn't suffer serious complications after surgery.
- T≥3 or N≥1, and more than 15 lymph nodes were dissected.
- Age ≥18 years and ≤75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Adequate hematological function:
Key exclusion criteria (6 listed)
- Suffering from previous primary malignancy or co-existing serious illness of other organs, which will affect the judgment of the end point of this study.
- Serious postoperative complications that will affect progress of chemotherapy.
- Patients with chemotherapy contraindications.
- Women who are pregnant or breast-feeding or who are planning for pregnancy.
- Unable to complete the follow-up as planned.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chemotherapypatients with R0 resected T≥3 or N≥1 thoracic esophageal squamous cell carcinoma began to receive chemotherapy of docetaxel combined with nedaplatin within 8 weeks after total two-field lymph node dissection. Docetaxel 75mg/m2 day 1, nedaplatin 75mg/m2 day 1, every 21 days for 4 cycles | Drug | Experimental group |
Primary outcome
Disease-free survival
Time frame: At most 5 years after enrollment
Patients were images with computed tomography (CT) scan
1 secondary outcome
overall survival
Time frame: At most 5 years after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
Related trials for Thoracic Esophageal Squamous Cell Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1
A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Metastatic Solid Tumor, Recurrent Solid Tumor
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
RecruitingObservational study
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
Esophageal Cancer, Head and Neck Cancer
Active, not recruitingPhase 1
Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors
Advanced or Metastatic Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chemotherapy in people with Thoracic Esophageal Squamous Cell Carcinoma, run by Sun Yat-Sen University Cancer Center 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 10 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 21 Jul 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peng Lin, professor (+86-20-87343314, linpeng@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: At most 5 years after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2026.