Esophagus CancerPhase 2NCT04764227

Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)

A Phase 2 study testing Paclitaxel, Carboplatin and Radiotherapy in people with Esophagus Cancer and Esophageal Squamous Cell Carcinoma, run by Fudan University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The purpose of this study is to evaluate safety and 2-year local control rate for postoperative concurrent chemoradiotherapy for esophageal squamous cell carcinoma. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Esophagus Cancer, Esophageal Squamous Cell Carcinoma, Chemoradiotherapy
What is being tested?: Paclitaxel, Carboplatin and Radiotherapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteChina
Study dates: 30 May 2020to 30 Mar 2027
Phase: Phase 2
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

Joined the study voluntarily and signed informed consent form;
Age 18-75;
ECOG 0-2;
Esophageal squamous cell carcinoma, radical surgery ≤ 3 months, R0 resection;
The operative incision healed well;
T3-4N0M0, T1-4N1-3M0 (according to AJCC2009);

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No radiotherapy, chemotherapy or other treatments pre (post) surgery;
PS ECOG 0-2;
Life expectancy of more than 3 months;
Hemoglobin (Hb) ≥ 9 g/dL, WBC ≥ 3 x 109/L, Neutrophils (ANC ) ≥ 1.5 x 109/L, Platelet count (Pt) ≥ 100 x 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;
Use of an effective contraceptive for adults to prevent pregnancy.

Who cannot join

Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis;
Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
Participation in other interventional clinical trials within 30 days;
Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;
Drug addiction, Alcoholism or AIDS;
Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
Unsuitable to be enrolled in the trial in the opinion of the investigators.

Trial locations and contacts

1 site in 1 country.

China1 site

Fudan University Shanghai Cancer Center
Shanghai, 200032

Other trials in China

About this study

The purpose of this study is to evaluate safety and 2-year local control rate for postoperative concurrent chemoradiotherapy for esophageal squamous cell carcinoma.

Conditions: Esophagus Cancer, Esophageal Squamous Cell Carcinoma, Chemoradiotherapy, Radiation Therapy, Postoperative
Being tested: Paclitaxel, Carboplatin, Radiotherapy
Medical subject headings: Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma

What participants receive

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

PaclitaxelDrug
paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1, qw*5
CarboplatinDrug
carboplatin AUC=2, ivgtt, d1, qw*5
RadiotherapyRadiation
1.8Gy/d, d1-5/week, 28Fx

Study groups in NCT04764227
Study group	Role	What they receive
Concurrent chemoradiotherapy group	Experimental	Interventions: * Chemotherapy: Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw5 Radiotherapy: A total dose of 50.4Gy will be delivered in 28 fractions at 1.8Gy/fraction, 5 fractions per week in 6 weeks. The CTV encompassed the bilateral supraclavicular, superior mediastinal, and subcarinal regions. Receives: Drug: Paclitaxel; Drug: Carboplatin; Radiation: Radiotherapy

What is being measured

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

Local control rate
Measured: 2 years

Secondary outcomes (1)

Overall survival
Measured: 5 years

Timeline

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

30 May 202030 Mar 2027

First posted21 Feb 2021
Study start30 May 2020
Primary completion30 Mar 2024 (estimated)
Study completion30 Mar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Esophagus CancerStudies of the same condition, open and under way.
More trials run by Fudan UniversityThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04764227
Sponsor's protocol ID: ESO- Shanghai 17
Status last verified: Aug 2023
First submitted: 19 Feb 2021
Last updated: 3 Aug 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Shen J, Ai D, Chen Y, Liu Q, Deng J, Hao S, Zhang X, Zhang J, Zhang Y, Chu L, Sun Y, Zhang Y, Xiang J, Miao L, Chen H, Zhu H, Zhao K. Postoperative chemoradiotherapy for esophageal squamous cell Carcinoma: Results from ESO-Shanghai 17 and joint analyses for phase II clinical trials. Clin Transl Radiat Oncol. 2025 Nov 21;57:101073. doi: 10.1016/j.ctro.2025.101073. eCollection 2026 Mar.
PubMed 41531940

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
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 4
Efficacy of Potassium-Competitive Acid Blockers in Barrett's Esophagus (PCAB BE Study)
Barrett Esophagus
RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma

All Esophagus Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)
ClinicalTrials.gov ID: NCT04764227
Acronym / sponsor ID: ESO- Shanghai 17
Conditions: Esophagus Cancer, Esophageal Squamous Cell Carcinoma, Chemoradiotherapy, Radiation Therapy, Postoperative
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 70 participants (actual)
Lead sponsor: Fudan UniversityUniversity, hospital or other
Study start: 30 May 2020 (actual)
Primary completion: 30 Mar 2024 (estimated)
Study completion: 30 Mar 2027 (estimated)
First posted: 21 Feb 2021 (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.

The purpose of this study is to evaluate safety and 2-year local control rate for postoperative concurrent chemoradiotherapy for esophageal squamous cell carcinoma.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Concurrent chemoradiotherapy group	Experimental	Drug: Paclitaxel, Drug: Carboplatin, Radiation: RadiotherapyInterventions: * Chemotherapy: Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw5 Radiotherapy: A total dose of 50.4Gy will be delivered in 28 fractions at 1.8Gy/fraction, 5 fractions per week in 6 weeks. The CTV encompassed the bilateral supraclavicular, superior mediastinal, and subcarinal regions.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Joined the study voluntarily and signed informed consent form;
Age 18-75;
ECOG 0-2;
Esophageal squamous cell carcinoma, radical surgery ≤ 3 months, R0 resection;
The operative incision healed well;

Key exclusion criteria (7 listed)

Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis;
Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
Participation in other interventional clinical trials within 30 days;
Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;
Drug addiction, Alcoholism or AIDS;

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
Paclitaxelpaclitaxel 50mg/m2/d, ivgtt over 3 hours, d1, qw*5	Drug	Concurrent chemoradiotherapy group
Carboplatincarboplatin AUC=2, ivgtt, d1, qw*5	Drug	Concurrent chemoradiotherapy group
Radiotherapy1.8Gy/d, d1-5/week, 28Fx	Radiation	Concurrent chemoradiotherapy group

Primary outcome

Local control rate
Time frame: 2 years

1 secondary outcome

Overall survival
Time frame: 5 years

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 3 Aug 2023.
Derived from this study: PubMed 41531940Shen J, Ai D, Chen Y, Liu Q, Deng J, Hao S, Zhang X, Zhang J, Zhang Y, Chu L, Sun Y, Zhang Y, Xiang J, Miao L, Chen H, Zhu H, Zhao K. Postoperative chemoradiotherapy for esophageal squamous cell Carcinoma: Results from ESO-Shanghai 17 and joint analyses for phase II clinical trials. Clin Transl Radiat Oncol. 2025 Nov 21;57:101073. doi: 10.1016/j.ctro.2025.101073. eCollection 2026 Mar.

Related trials for Esophagus Cancer

RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
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 4
Efficacy of Potassium-Competitive Acid Blockers in Barrett's Esophagus (PCAB BE Study)
Barrett Esophagus
RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma

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. This study is not recruiting at the moment.

Kuaile Zhao principal investigator

Fudan University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Carboplatin and Radiotherapy in people with Esophagus Cancer and 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 14 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2023. 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?

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?

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: 2 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 NCT04764227, 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 3 Aug 2023.