Clinical trial · Interventional
Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor
Phase III Randomized-controlled Study of PD-1 Inhibitor Combined With Local Therapy in Patients With Oligometastatic Esophageal Squamous Cell Carcinoma
NCT06190782CI-TRIAL-00076659recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Oligometastatic Disease | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 inhibitor+/- chemotherapy combined with local therapy | Combination Product | — | UNRESOLVED |
| systemic therapy alone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PD-1 inhibitor+/- chemotherapy combined with local therapy
- description
- Patients randomized to this arm will receive local treatment combined with systemic treatment (immunotherapy or chemo-immunotherapy)
- interventionNames
- Combination Product: PD-1 inhibitor+/- chemotherapy combined with local therapy
- type
- ACTIVE_COMPARATOR
- label
- PD-1 inhibitor +/- chemotherapy alone
- description
- Patients randomized to this arm will receive only systemic treatment (immunotherapy or chemo-immunotherapy)
- interventionNames
- Drug: systemic therapy alone
Primary outcomes (1)
- measure
- Progression-free survival difference of PD-1 inhibitor+radiotherapy and PD-1 inhibitor alone
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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%
References
Publications (1)
- DERIVEDMao 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. PMID 40734507