Esophageal Squamous Cell CarcinomaPhase 3NCT06190782
Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor
A Phase 3 study testing PD-1 inhibitor+/- chemotherapy combined with local therapy and systemic therapy alone in people with Esophageal Squamous Cell Carcinoma and Oligometastatic Disease, run by Fudan University at 1 site in China.
Trial summary
Patients with oligometastatic squamous cell carcinoma were enrolled and randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy or PD-1 inhibitor +/- chemotherapy alone. The primary end point was progression-free survival (PFS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Oligometastatic Disease, Radiotherapy
- What is being tested?
- PD-1 inhibitor+/- chemotherapy combined with local therapy and systemic therapy alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2022to 27 Sep 2027
- 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
- 1. ≥18 years old; 2. ECOG 0-1; 3. Esophageal squamous cell carcinoma 4. ASTRO/ESTRO defined genuine oligometastatic disease and consistent with: i. ≤4 distant metastases, ii. ≤3 metastatic lesions within a single organ, iii. maximum diameter of each metastatic lesion ≤5cm; 5. ≥1 pathologically diagnosed metastases
Who cannot join
- 1. History of disseminated metastases or ASTRO/ESTRO defined induced oligometastatic disease 2.Esophageal perforation/hemorrhage 3.Progression disease after PD-1 inhibitor treatment 4.In-field recurrence 5.Intolerance to chemotherapy or immunotherapy 6.lung V20>25%
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, MD, 86-18017312534, kuaile_z@sina.com
About this study
Official title: Phase III Randomized-controlled Study of PD-1 Inhibitor Combined With Local Therapy in Patients With Oligometastatic Esophageal Squamous Cell Carcinoma
Patients with oligometastatic squamous cell carcinoma were enrolled and randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy or PD-1 inhibitor +/- chemotherapy alone.
The primary end point was progression-free survival (PFS). The secondary end points included overall survival, side effects and local control.
Read the detailed description
Patients with oligometastatic squamous cell carcinoma were enrolled and 2:1 randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy (radiotherapy, surgery, radiofrequency/microwave ablation, etc.) or PD-1 inhibitor +/- chemotherapy alone. Different local therapy techniques are allowed to be used on different lesions in the same patient.All suspected malignant lesion should be included in local treatment planning in principle.
The primary end point was progression-free survival (PFS). The second end points included overall survival, side effects and local control.
- Being tested
- PD-1 inhibitor+/- chemotherapy combined with local therapy, systemic therapy alone
- Keywords
- esophageal squamous cell carcinom, Oligometastatic, Radiotherapy, pd-1 inhibitor
- 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.
PD-1 inhibitor+/- chemotherapy combined with local therapyCombination product
- PD-1 inhibitor +/- Chemotherapy PD-1 inhibitor: all FDA approved PD-1 inhibitor producter is suitable First line:
- TP: paclitaxel 135-175mg/m2,d1+ DDP25mg/m2, d1-3 or 75mg/m2,d1;q21d (albumin-bound paclitaxel or paclitaxel liposomes as alternative of paclitaxel permitted as alternative) or ii. PF: DDP Second line (other platinum-based agents permitted as alternative such as carboplatin, nedaplatin, oxaliplatin, lobaplatin, etc.) i. Docetaxel or ii. Irinotecan or iii. Paclitaxel (albumin-bound paclitaxel or paclitaxel liposomes as alternative of paclitaxel permitted as alternatives)
- Local therapy i. Radiotherapy GTV=all suspected lesions. SBRT: for lung, liver, adrenal gland, celiac lymphnode metatstases 48Gy/6fx; for spine metastatic disease 30Gy/10Fx; for brain metastases 24Gy/30fx; IMRT: for bone metastatic disease 30Gy/10fx; for esophageal lesion or lesion unsuitable of SBRT 50.4Gy/28fx; ii. Surgery iii. Radiofrequency/microwave ablation
systemic therapy aloneDrug
Also called the systemic therapy only
1.PD-1 inhibitor +/- Chemotherapy PD-1 inhibitor: all FDA approved PD-1 inhibitor producter is suitable
First line:
- TP: paclitaxel 135-175mg/m2,d1+ DDP25mg/m2, d1-3 or 75mg/m2,d1;q21d (albumin-bound paclitaxel or paclitaxel liposomes as alternative of paclitaxel permitted as alternative) or ii. PF: DDP Second line (other platinum-based agents permitted as alternative such as carboplatin, nedaplatin, oxaliplatin, lobaplatin, etc.) i. Docetaxel or ii. Irinotecan or iii. Paclitaxel (albumin-bound paclitaxel or paclitaxel liposomes as alternative of paclitaxel permitted as alternatives)
| Study group | Role | What they receive |
|---|---|---|
| PD-1 inhibitor+/- chemotherapy combined with local therapy | Experimental | Patients randomized to this arm will receive local treatment combined with systemic treatment (immunotherapy or chemo-immunotherapy) Receives: Combination Product: PD-1 inhibitor+/- chemotherapy combined with local therapy |
| PD-1 inhibitor +/- chemotherapy alone | Active comparator | Patients randomized to this arm will receive only systemic treatment (immunotherapy or chemo-immunotherapy) Receives: Drug: systemic therapy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival difference of PD-1 inhibitor+radiotherapy and PD-1 inhibitor alone
The time between the start of the study treatment(day 1) and progression disease(PD)
Measured: 3-year
Secondary outcomes (3)
overall survival difference of PD-1 inhibitor+radiotherapy and PD-1 inhibitor alone
The time between the start of the study treatment(day 1) and death from an cause or last follow-up for patients alive at the end of the study
Measured: 3-year
treatment related side effect
Record the treatment related side effects including acute and late side effects
Measured: acute side effects within 3 months, late side effects for 3 months later
local control rate
the portion of patients who do not develop progression disease or exacerbation of clinical symptoms despite stable disease
Measured: 1-year, 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start27 Sep 2022
- Primary completion27 Sep 2025 (estimated)
- Study completion27 Sep 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 Esophageal Squamous Cell 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
- 354 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
- Investigators
- Kuaile Zhao, MD, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190782
- Sponsor's protocol ID
- ESO-Shanghai20
- Status last verified
- Apr 2024
- First submitted
- 20 Dec 2023
- Last updated
- 2 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mao G, Xin Z, Fan Q, Zhu H, Ye J, Zhou L, He Y, Xu B, Chen C, Li Z, Gu X, Li X, Wang X, Guo J, Xu Z, Wan P, Zhang Y, Zhang F, Huang C, Yi Q, Huang J, Liang S, Chen J, Lin Y, Fang Q, Chen Y, Ai D, Zhu H, Hao S, Liu Q, Zhao K. ESO-Shanghai 20: phase III clinical trial of anti-PD-1 therapy with local intervention for oligometastatic ESCC. Future Oncol. 2025 Aug;21(20):2575-2584. doi: 10.1080/14796694.2025.2534770. Epub 2025 Jul 30.
PubMed 40734507
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized-controlled Study of PD-1 Inhibitor Combined With Local Therapy in Patients With Oligometastatic Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06190782
- Acronym / sponsor ID
- ESO-Shanghai20
- Keywords
- esophageal squamous cell carcinom, Oligometastatic, Radiotherapy, pd-1 inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 27 Sep 2025 (estimated)
- Study completion
- 27 Sep 2027 (estimated)
- First posted
- 5 Jan 2024 (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 oligometastatic squamous cell carcinoma were enrolled and randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy or PD-1 inhibitor +/- chemotherapy alone.
The primary end point was progression-free survival (PFS). The secondary end points included overall survival, side effects and local control.
Detailed description
Patients with oligometastatic squamous cell carcinoma were enrolled and 2:1 randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy (radiotherapy, surgery, radiofrequency/microwave ablation, etc.) or PD-1 inhibitor +/- chemotherapy alone. Different local therapy techniques are allowed to be used on different lesions in the same patient.All suspected malignant lesion should be included in local treatment planning in principle.
The primary end point was progression-free survival (PFS). The second end points included overall survival, side effects and local control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD-1 inhibitor+/- chemotherapy combined with local therapy | Experimental | Combination Product: PD-1 inhibitor+/- chemotherapy combined with local therapyPatients randomized to this arm will receive local treatment combined with systemic treatment (immunotherapy or chemo-immunotherapy) |
| PD-1 inhibitor +/- chemotherapy alone | Active comparator | Drug: systemic therapy alonePatients randomized to this arm will receive only systemic treatment (immunotherapy or chemo-immunotherapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. ≥18 years old; 2. ECOG 0-1; 3. Esophageal squamous cell carcinoma 4. ASTRO/ESTRO defined genuine oligometastatic disease and consistent with: i. ≤4 distant metastases, ii. ≤3 metastatic lesions within a single organ, iii. maximum diameter of each metastatic lesion ≤5cm; 5. ≥1 pathologically diagnosed metastases
Key exclusion criteria (1 listed)
- 1. History of disseminated metastases or ASTRO/ESTRO defined induced oligometastatic disease 2.Esophageal perforation/hemorrhage 3.Progression disease after PD-1 inhibitor treatment 4.In-field recurrence 5.Intolerance to chemotherapy or immunotherapy 6.lung V20>25%
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 inhibitor+/- chemotherapy combined with local therapy1. PD-1 inhibitor +/- Chemotherapy PD-1 inhibitor: all FDA approved PD-1 inhibitor producter is suitable First line: i. TP: paclitaxel 135-175mg/m2,d1+ DDP25mg/m2, d1-3 or 75mg/m2,d1;q21d (albumin-bound paclitaxel or paclitaxel liposomes as alternative of paclitaxel permitted as alternative) or ii. PF: DDP Second line (other platinum-based agents permitted as alternative such as carboplatin, nedaplatin, oxaliplatin, lobaplatin, etc.) i. Docetaxel or ii. Irinotecan or iii. Paclitaxel (albumin-bound paclitaxel or paclitaxel liposomes as alternative of paclitaxel permitted as alternatives) 2. Local therapy i. Radiotherapy GTV=all suspected lesions. SBRT: for lung, liver, adrenal gland, celiac lymphnode metatstases 48Gy/6fx; for spine metastatic disease 30Gy/10Fx; for brain metastases 24Gy/30fx; IMRT: for bone metastatic disease 30Gy/10fx; for esophageal lesion or lesion unsuitable of SBRT 50.4Gy/28fx; ii. Surgery iii. Radiofrequency/microwave ablation | Combination product | PD-1 inhibitor+/- chemotherapy combined with local therapy |
| systemic therapy aloneAlso: the systemic therapy only1.PD-1 inhibitor +/- Chemotherapy PD-1 inhibitor: all FDA approved PD-1 inhibitor producter is suitable First line: i. TP: paclitaxel 135-175mg/m2,d1+ DDP25mg/m2, d1-3 or 75mg/m2,d1;q21d (albumin-bound paclitaxel or paclitaxel liposomes as alternative of paclitaxel permitted as alternative) or ii. PF: DDP Second line (other platinum-based agents permitted as alternative such as carboplatin, nedaplatin, oxaliplatin, lobaplatin, etc.) i. Docetaxel or ii. Irinotecan or iii. Paclitaxel (albumin-bound paclitaxel or paclitaxel liposomes as alternative of paclitaxel permitted as alternatives) | Drug | PD-1 inhibitor +/- chemotherapy alone |
Primary outcome
Progression-free survival difference of PD-1 inhibitor+radiotherapy and PD-1 inhibitor alone
Time frame: 3-year
The time between the start of the study treatment(day 1) and progression disease(PD)
3 secondary outcomes
overall survival difference of PD-1 inhibitor+radiotherapy and PD-1 inhibitor alone
Time frame: 3-year
treatment related side effect
Time frame: acute side effects within 3 months, late side effects for 3 months later
local control rate
Time frame: 1-year, 3-year
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 2 May 2024.
- Derived from this study: PubMed 40734507Mao G, Xin Z, Fan Q, Zhu H, Ye J, Zhou L, He Y, Xu B, Chen C, Li Z, Gu X, Li X, Wang X, Guo J, Xu Z, Wan P, Zhang Y, Zhang F, Huang C, Yi Q, Huang J, Liang S, Chen J, Lin Y, Fang Q, Chen Y, Ai D, Zhu H, Hao S, Liu Q, Zhao K. ESO-Shanghai 20: phase III clinical trial of anti-PD-1 therapy with local intervention for oligometastatic ESCC. Future Oncol. 2025 Aug;21(20):2575-2584. doi: 10.1080/14796694.2025.2534770. Epub 2025 Jul 30.
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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?
A Phase 3 study testing PD-1 inhibitor+/- chemotherapy combined with local therapy and systemic therapy alone in people with Esophageal Squamous Cell Carcinoma and Oligometastatic Disease, 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 1 inclusion and 1 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 2 May 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 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 Qi Liu, MD (86-18017317882, 18017317882@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival difference of PD-1 inhibitor+radiotherapy and PD-1 inhibitor alone (time frame: 3-year). 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 NCT06190782, 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 2 May 2024.