Treatment for patients with oligometastatic esophageal cancer using PD-1 inhibitors and local therapy
Official title: Phase III Randomized-controlled Study of PD-1 Inhibitor Combined With Local Therapy in Patients With Oligometastatic Esophageal Squamous Cell Carcinoma
Run by Fudan University · NCT06190782 · Data updated 2026-11-12
This study is testing if adding local treatments like surgery or radiation to a PD-1 inhibitor and chemotherapy can help people with oligometastatic esophageal cancer live longer without their cancer getting worse.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 354 (estimated) |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | September 27, 2022 |
| Main results expected | September 27, 2025 |
| Study ends | September 27, 2027 |
| Registry record updated | May 2, 2024 |
| Trial ID | NCT06190782 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with oligometastatic esophageal squamous cell carcinoma and specific criteria regarding the number and size of metastases.
✕Probably not a fit
Patients with a history of disseminated metastases or those who have progressed after PD-1 inhibitor treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial involves patients with oligometastatic esophageal squamous cell carcinoma who are randomly assigned to receive either a PD-1 inhibitor combined with local therapy (such as radiotherapy or surgery) and chemotherapy, or the PD-1 inhibitor and chemotherapy alone. The study aims to evaluate the effectiveness of combining local therapy with systemic treatment in improving progression-free survival. The primary endpoint is progression-free survival, while secondary endpoints include overall survival, side effects, and local control of the disease.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with oligometastatic esophageal cancer.
How similar studies have gone: Other studies have shown promise in using local therapies in conjunction with systemic treatments for oligometastatic cancers, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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%
Where it's running
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Fudan University Shanghai cancer center
Shanghai, China Recruiting
Study contacts
- Study coordinator: Qi Liu, MD
- Email: 18017317882@163.com
- Phone: 86-18017317882
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.