Esophageal Squamous Cell Carcinoma (ESCC)ESO-shanghai31NCT07697859
PD-1 Inhibitors Combined With Local Therapy at Different Timings in Oligometastatic ESCC
An observational study of Esophageal Squamous Cell Carcinoma (ESCC), run by Fudan University at 1 site in China.
Trial summary
Although immunotherapy combined with chemotherapy has become the first-line standard regimen for advanced esophageal squamous cell carcinoma (ESCC) and improved clinical outcomes in advanced patients, the prognosis of patients with esophageal cancer remains unsatisfactory, with a 5-year overall survival rate below… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC)
- What is being tested?
- Two arms adopt local intervention administered at distinct timings.
- How many people
- 354 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2026to 15 Jul 2031
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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
Study population: Oligometastatic ESCC
Who may be able to join
- An eastern cooperative oncology group (ECOG) score of 0-1.
- Histologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma.
- Genuine oligometastasis (without a history of polyme-tastatic disease).
- A total of four or fewer distant metastases, a maximum of three metastases in a single organ, and a maximum diameter of each metastatic lesion not exceeding 5 cm.
- Biopsy of a metastatic lesion, PET/CT scan, and PD-L1 CPS (IHC 22C3) are not required but preferred.
- No history of anti-PD-1/PD-L1 therapy. However, the following conditions are also eligible for inclusion: the use of anti-PD1/PD-L1 during induction/neoadjuvant/ concurrent therapy, or the use of anti-PD1/PD-L1 for maintenance therapy but not due to toxicity or disease progression interrupting anti-PD1/PD-L1 treatment, and the interruption has lasted for more than 3 months.
- Adequate hematological, hepatic, renal, and coagula-tion function. Baseline laboratory tests required to assess eligibility, including ANC ≥ 1.5 × 10^9/L, PLT ≥ 80 × 10^9/L, Hb ≥85 g/L, ALB ≥28 g/L, TBIL ≤ 1.5 × ULN, ALT and AST ≤ 3 × ULN, Cr ≤ 1.5 × ULN or CrCl ≥40 mL/min, FEV1 ≥ 1 L. (liver metastases ALT and AST ≤ 5 × ULN, liver or bone metastases AKP ≤ 5 × ULN).(9) Enrolled voluntarily and signed informed consent by the patient himself or his legal representative.
Who cannot join
- Pregnant or lactating women.
- Lung V20 remains over 25%.
- Confirmed diagnosis or clinical suspicion of esophageal fistula.
- Recurrence in the irradiated field.
- Active infection requiring systemic therapy.
- Active autoimmune disease requiring systemic treat-ment in the past 2 years.
Show all 11Show fewer
- Immunodeficiency diagnosis, systemic steroid therapy, or any immunosuppressive treatment within 7 days before the first study treatment dose.
- Patients with a known history of grade 3 or higher adverse events, which are unsuitable for Anti-PD-1 therapy or adverse events that have not recovered to ≤CTCAE grade 1 (except alopecia).
- Uncontrolled pleural effusion, pericardial effusion, or pelvic ascites requiring repeated drainage.
- Unable or rejection to receive Anti-PD-1 therapy or unable to comply with study requirements or follow-up schedule.(11) Inability to provide informed consent.
- -
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, Shanghai Municipality
Guangmin Mao, 86-13732284526, melly01@126.com
Kuaile Zhao, MD
About this study
Official title: A Phase III Randomized Controlled Study Investigating the Combination of PD-1 Inhibitors With Local Therapy Administered at Distinct Treatment Timings Among Patients With Oligometastatic Esophageal Squamous Cell Carcinoma
Although immunotherapy combined with chemotherapy has become the first-line standard regimen for advanced esophageal squamous cell carcinoma (ESCC) and improved clinical outcomes in advanced patients, the prognosis of patients with esophageal cancer remains unsatisfactory, with a 5-year overall survival rate below 20%. As an effective modality for local disease control, local radiotherapy has no established optimal sequencing schedule when combined with systemic therapy. The timing of radiotherapy intervention may directly affect treatment efficacy, treatment tolerance and quality of life of patients.
Several studies have explored the impact of radiotherapy timing in oligometastatic ESCC, yet substantial limitations persist in current evidence, resulting in a lack of unified guideline recommendations and wide heterogeneity in clinical practice. Most existing investigations are retrospective or small-sample prospective studies with high heterogeneity in study design, patient population selection and treatment regimens, yielding inconsistent conclusions that cannot support consistent clinical consensus.
To clarify the impact of radiotherapy timing on clinical efficacy in oligometastatic esophageal cancer, the investigator designed the present clinical trial. This study aims to compare the efficacy and safety of concurrent radiotherapy versus sequential radiotherapy on the basis of immunochemotherapy among patients with oligometastatic ESCC, so as to fill the evidence gap in existing research.
- Being tested
- Two arms adopt local intervention administered at distinct timings.
- Keywords
- Esophageal Squamous Cell Carcinoma, Anti-PD-1, Oligometastatis, Radiotherapy
- 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.
Two arms adopt local intervention administered at distinct timings.Other
Both study arms receive chemoimmunotherapy combined with local intervention modalities, which encompass radiotherapy, surgery and ablation. In the early local therapy arm, local intervention is initiated within 2 cycles of chemoimmunotherapy, whereas patients in the delayed local therapy arm start local intervention after completing 4 cycles of chemoimmunotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Early Local Therapy Arm | Patients assigned to this study arm will initiate local therapy prior to the administration of the first two cycles of systemic treatment (immunotherapy or chemoimmunotherapy). Receives: Other: Two arms adopt local intervention administered at distinct timings. | |
| Delayed Local Therapy Arm | Patients assigned to this study arm will initiate local therapy after completion of the first four cycles of systemic treatment (immunotherapy or chemoimmunotherapy). Receives: Other: Two arms adopt local intervention administered at distinct timings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival (PFS）
PFS is defined as the time interval between the date of the first treatment and the date of first confirmed disease progression or death from any cause. If the patient does not have tumor progression or death at the time of data analysis, the time of the last tumor evaluation will be used as the endpoint for PFS.
Measured: 3-years
overall survival (OS)
the interval between the date of first systemic treatment and the date of death from any cause, and for patients who are still alive at the time point of the final analysis, the time of their last contact will be used as the survival time.
Measured: 3-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion15 Jul 2029 (estimated)
- Study completion15 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell Carcinoma (ESCC)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 354 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuai Le Zhao, MD, Fudan University
- Investigators
- Kuaile Zhao, MD, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697859
- Sponsor's protocol ID
- ESO-shanghai 31
- Acronym
- ESO-shanghai31
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Controlled Study Investigating the Combination of PD-1 Inhibitors With Local Therapy Administered at Distinct Treatment Timings Among Patients With Oligometastatic Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07697859
- Acronym / sponsor ID
- ESO-shanghai31 / ESO-shanghai 31
- Keywords
- Esophageal Squamous Cell Carcinoma, Anti-PD-1, Oligometastatis, Radiotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 15 Jul 2029 (estimated)
- Study completion
- 15 Jul 2031 (estimated)
- First posted
- 13 Jul 2026 (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.
Although immunotherapy combined with chemotherapy has become the first-line standard regimen for advanced esophageal squamous cell carcinoma (ESCC) and improved clinical outcomes in advanced patients, the prognosis of patients with esophageal cancer remains unsatisfactory, with a 5-year overall survival rate below 20%. As an effective modality for local disease control, local radiotherapy has no established optimal sequencing schedule when combined with systemic therapy. The timing of radiotherapy intervention may directly affect treatment efficacy, treatment tolerance and quality of life of patients.
Several studies have explored the impact of radiotherapy timing in oligometastatic ESCC, yet substantial limitations persist in current evidence, resulting in a lack of unified guideline recommendations and wide heterogeneity in clinical practice. Most existing investigations are retrospective or small-sample prospective studies with high heterogeneity in study design, patient population selection and treatment regimens, yielding inconsistent conclusions that cannot support consistent clinical consensus.
To clarify the impact of radiotherapy timing on clinical efficacy in oligometastatic esophageal cancer, the investigator designed the present clinical trial. This study aims to compare the efficacy and safety of concurrent radiotherapy versus sequential radiotherapy on the basis of immunochemotherapy among patients with oligometastatic ESCC, so as to fill the evidence gap in existing research.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Local Therapy Arm | – | Other: Two arms adopt local intervention administered at distinct timings.Patients assigned to this study arm will initiate local therapy prior to the administration of the first two cycles of systemic treatment (immunotherapy or chemoimmunotherapy). |
| Delayed Local Therapy Arm | – | Other: Two arms adopt local intervention administered at distinct timings.Patients assigned to this study arm will initiate local therapy after completion of the first four cycles of systemic treatment (immunotherapy or chemoimmunotherapy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oligometastatic ESCC
Key inclusion criteria (7 listed)
- An eastern cooperative oncology group (ECOG) score of 0-1.
- Histologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma.
- Genuine oligometastasis (without a history of polyme-tastatic disease).
- A total of four or fewer distant metastases, a maximum of three metastases in a single organ, and a maximum diameter of each metastatic lesion not exceeding 5 cm.
- Biopsy of a metastatic lesion, PET/CT scan, and PD-L1 CPS (IHC 22C3) are not required but preferred.
Key exclusion criteria (11 listed)
- Pregnant or lactating women.
- Lung V20 remains over 25%.
- Confirmed diagnosis or clinical suspicion of esophageal fistula.
- Recurrence in the irradiated field.
- Active infection requiring systemic therapy.
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 |
|---|---|---|
| Two arms adopt local intervention administered at distinct timings.Both study arms receive chemoimmunotherapy combined with local intervention modalities, which encompass radiotherapy, surgery and ablation. In the early local therapy arm, local intervention is initiated within 2 cycles of chemoimmunotherapy, whereas patients in the delayed local therapy arm start local intervention after completing 4 cycles of chemoimmunotherapy. | Other | Delayed Local Therapy Arm, Early Local Therapy Arm |
Primary outcome
progression free survival (PFS）
Time frame: 3-years
PFS is defined as the time interval between the date of the first treatment and the date of first confirmed disease progression or death from any cause. If the patient does not have tumor progression or death at the time of data analysis, the time of the last tumor evaluation will be used as the endpoint for PFS.
overall survival (OS)
Time frame: 3-years
the interval between the date of first systemic treatment and the date of death from any cause, and for patients who are still alive at the time point of the final analysis, the time of their last contact will be used as the survival time.
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 13 Jul 2026.
- Individual participant dataSharing planned: Yes
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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.
Kuaile Zhao, MD study director
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Squamous Cell Carcinoma (ESCC), 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 7 inclusion and 11 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 13 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 Guangmin Mao (86-13732284526, melly01@256.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (PFS） (time frame: 3-years). The study lists 2 primary outcomes in all. 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 13 Jul 2026.