Esophageal CarcinomaPhase 3NCT06964568
CCRT Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced ESCC
A Phase 3 study testing PD-1 inhibitor, Unlimited radiotherapy and TP regimen in people with Esophageal Carcinoma and Radiotherapy, run by Fudan University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if concurrent chemoradiotherapy followed by immunotherapy as maintenance therapy works to treat locally advanced esophageal squamous cell cancer in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Carcinoma, Radiotherapy, Immunotherapy
- What is being tested?
- PD-1 inhibitor, Unlimited radiotherapy and TP regimen
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to Feb 2031
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Aged 18 years or above
- Histologically confirmed esophageal squamous cell carcinoma
- Clinical stages T3-4N0M0 or TxN+M0 or TxNxM1 (Only for supraclavicular lymph nodes) based on the 8th UICC-TNM classification
- 7. Eastern Cooperative Oncology Group(ECOG) performance status: 0-1 8. Life expectancy ≥3 months 9. Adequate organ functions Absolute neutrophil counts (ANC) ≥1.5×109⁄L; Hemoglobin (Hb) ≥9g⁄dl; Platelet (Plt) ≥100×109⁄L; Total bilirubin ≤1.5 upper limit of normal (ULN); Aspartate transaminase (AST) ≤2.5 ULN; Alanine aminotransferase (ALT) ≤2.5 ULN; Creatinine ≤1.5 ULN
Who cannot join
- Esophageal perforation or hematemesis
- Any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism and hypothyroidism (effective hormone replacement therapy excepted)) and immunosuppressive agents or systemic hormonal therapy indicated within 28 days (for adverse events of chemoradiotherapy excepted).
- Previously received or receiving PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1.
- Allergic to any of the ingredients in PD-1 inhibitors for injection.
- Uncontrolled heart diseases or clinical symptoms, such as: (1) New York Heart Association(NYHA) class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4)clinically significant arrhythmia requiring clinical intervention.
- Congenital or acquired immunodeficiency (such as HIV infection); active hepatitis B (HBV-DNA≥104 copy number/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method); active tuberculosis.
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- Active infection or unexplained fever >38.5 °C within 2 weeks before randomization (fever due to tumor excepted, according to investigator).
- Patients with fertility reluctant to take contraceptive measures during the trial, or female patients pregnant or breastfeeding.
- According to the investigator, other factors that may cause termination of the study. ie, other serious diseases (including mental illness) require combined treatment, family or social factors, which may affect the safety or the collection of trial data.
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
Fudan University Shanghai Cancer Center
Shanghai
Kuaile Zhao, +86-21-64175590, kuaile_z@sina.com
About this study
Official title: Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized Phase III Trial
The goal of this clinical trial is to learn if concurrent chemoradiotherapy followed by immunotherapy as maintenance therapy works to treat locally advanced esophageal squamous cell cancer in adults.
- Conditions
- Esophageal Carcinoma, Radiotherapy, Immunotherapy
- Being tested
- PD-1 inhibitor, Unlimited radiotherapy, TP regimen, TDLN-sparing radiotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 inhibitorDrug
PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year.
Unlimited radiotherapyRadiation
Unlimited radiotherapy 50.4Gy/28Fx
TP regimenDrug
Chemotherapy: Paclitaxel 135mg/m2 d1+cisplatin 25mg/m2 d1-3 q28d
TDLN-sparing radiotherapyRadiation
Tumor draining lymph nodes-sparing radiotherapy 50.4Gy/28Fx
| Study group | Role | What they receive |
|---|---|---|
| Unlimited RT and PD-1 inhibitor maintenance therapy | Experimental | Unlimited radiotherapy 50.4Gy/28Fx.
PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year followed by radiotherapy. Receives: Drug: PD-1 inhibitor; Radiation: Unlimited radiotherapy; Drug: TP regimen |
| Unlimited RT and surveillance | Active comparator | Unlimited radiotherapy 50.4Gy/28Fx. Receives: Radiation: Unlimited radiotherapy; Drug: TP regimen |
| TDLN-sparing RT and PD-1 inhibitor maintenance therapy | Experimental | TDLN-sparing radiotherapy 50.4Gy/28Fx.
PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year followed by radiotherapy. Receives: Drug: PD-1 inhibitor; Drug: TP regimen; Radiation: TDLN-sparing radiotherapy |
| TDLN-sparing RT and surveillance | Experimental | TDLN-sparing radiotherapy 50.4Gy/28Fx. Receives: Drug: TP regimen; Radiation: TDLN-sparing radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS for all patients with PD-1 inhibitor maintenance therapy vs all patients with surveillance
Measured: 2 years
Secondary outcomes (4)
PFS
PFS for TDLN-sparing RT followed by PD-1 inhibitor maintenance therapy vs TDLN-sparing RT followed by surveillance
Measured: 2 years
OS
OS for TDLN-sparing RT followed by PD-1 inhibitor maintenance therapy vs TDLN-sparing RT followed by surveillance
Measured: 2 years
OS
OS for all patients with PD-1 inhibitor maintenance therapy vs all patients with surveillance
Measured: 2 years
Adverse events
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 Feb 2025
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CarcinomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 452 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuai Le Zhao, MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964568
- Sponsor's protocol ID
- ESO-Shanghai 27
- Status last verified
- Apr 2026
- First submitted
- 1 May 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized Phase III Trial
- ClinicalTrials.gov ID
- NCT06964568
- Acronym / sponsor ID
- ESO-Shanghai 27
- Conditions
- Esophageal Carcinoma, Radiotherapy, Immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 452 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 9 May 2025 (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 goal of this clinical trial is to learn if concurrent chemoradiotherapy followed by immunotherapy as maintenance therapy works to treat locally advanced esophageal squamous cell cancer in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Unlimited RT and PD-1 inhibitor maintenance therapy | Experimental | Drug: PD-1 inhibitor, Radiation: Unlimited radiotherapy, Drug: TP regimenUnlimited radiotherapy 50.4Gy/28Fx. PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year followed by radiotherapy. |
| Unlimited RT and surveillance | Active comparator | Radiation: Unlimited radiotherapy, Drug: TP regimenUnlimited radiotherapy 50.4Gy/28Fx. |
| TDLN-sparing RT and PD-1 inhibitor maintenance therapy | Experimental | Drug: PD-1 inhibitor, Drug: TP regimen, Radiation: TDLN-sparing radiotherapyTDLN-sparing radiotherapy 50.4Gy/28Fx. PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year followed by radiotherapy. |
| TDLN-sparing RT and surveillance | Experimental | Drug: TP regimen, Radiation: TDLN-sparing radiotherapyTDLN-sparing radiotherapy 50.4Gy/28Fx. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent
- Aged 18 years or above
- Histologically confirmed esophageal squamous cell carcinoma
- Clinical stages T3-4N0M0 or TxN+M0 or TxNxM1 (Only for supraclavicular lymph nodes) based on the 8th UICC-TNM classification
- 7. Eastern Cooperative Oncology Group(ECOG) performance status: 0-1 8. Life expectancy ≥3 months 9. Adequate organ functions Absolute neutrophil counts (ANC) ≥1.5×109⁄L; Hemoglobin (Hb) ≥9g⁄dl; Platelet (Plt) ≥100×109⁄L; Total bilirubin ≤1.5 upper limit of normal (ULN); Aspartate transaminase (AST) ≤2.5 ULN; Alanine aminotransferase (ALT) ≤2.5 ULN; Creatinine ≤1.5 ULN
Key exclusion criteria (9 listed)
- Esophageal perforation or hematemesis
- Any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism and hypothyroidism (effective hormone replacement therapy excepted)) and immunosuppressive agents or systemic hormonal therapy indicated within 28 days (for adverse events of chemoradiotherapy excepted).
- Previously received or receiving PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1.
- Allergic to any of the ingredients in PD-1 inhibitors for injection.
- Uncontrolled heart diseases or clinical symptoms, such as: (1) New York Heart Association(NYHA) class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4)clinically significant arrhythmia requiring clinical intervention.
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 |
|---|---|---|
| PD-1 inhibitorPD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year. | Drug | TDLN-sparing RT and PD-1 inhibitor maintenance therapy, Unlimited RT and PD-1 inhibitor maintenance therapy |
| Unlimited radiotherapyUnlimited radiotherapy 50.4Gy/28Fx | Radiation | Unlimited RT and PD-1 inhibitor maintenance therapy, Unlimited RT and surveillance |
| TP regimenChemotherapy: Paclitaxel 135mg/m2 d1+cisplatin 25mg/m2 d1-3 q28d | Drug | TDLN-sparing RT and PD-1 inhibitor maintenance therapy, TDLN-sparing RT and surveillance, Unlimited RT and PD-1 inhibitor maintenance therapy, Unlimited RT and surveillance |
| TDLN-sparing radiotherapyTumor draining lymph nodes-sparing radiotherapy 50.4Gy/28Fx | Radiation | TDLN-sparing RT and PD-1 inhibitor maintenance therapy, TDLN-sparing RT and surveillance |
Primary outcome
PFS
Time frame: 2 years
PFS for all patients with PD-1 inhibitor maintenance therapy vs all patients with surveillance
4 secondary outcomes
PFS
Time frame: 2 years
OS
Time frame: 2 years
OS
Time frame: 2 years
Adverse events
Time frame: up to 2 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 17 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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 Phase 3 study testing PD-1 inhibitor, Unlimited radiotherapy and TP regimen in people with Esophageal Carcinoma and Radiotherapy, 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 5 inclusion and 9 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 17 Apr 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Kuaile Zhao, MD (+86-21-64175590, kuaile_z@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 2 years). 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 17 Apr 2026.