Treatment for patients with oligometastatic esophageal cancer using PD-1 inhibitors and local therapy
Phase III Randomized-controlled Study of PD-1 Inhibitor Combined With Local Therapy in Patients With Oligometastatic Esophageal Squamous Cell Carcinoma
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 |
| Enrollment | 354 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06190782 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with oligometastatic esophageal cancer.
How similar studies have performed: Other studies have shown promise in using local therapies in conjunction with systemic treatments for oligometastatic cancers, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Shanghai
- Fudan University Shanghai cancer center — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Qi Liu, MD
- Email: 18017317882@163.com
- Phone: 86-18017317882
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.