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Recruiting NCT06190782

Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor

Phase III Interventional Esophageal Squamous Cell Carcinoma Oligometastatic Disease Radiotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PD-1 inhibitor+/- chemotherapy combined with local therapy, systemic therapy alone.
Who it may be relevant to
Registry conditions: Esophageal Squamous Cell Carcinoma, Oligometastatic Disease, Radiotherapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Phase III Randomized-controlled Study of PD-1 Inhibitor Combined With Local Therapy in Patients With Oligometastatic Esophageal Squamous Cell Carcinoma

Overview

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.

Interventions

  • Combination product PD-1 inhibitor+/- chemotherapy combined with local therapy
    1. 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 (alb
  • Drug systemic therapy alone
    1.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-bo

Primary outcome measures

  • Progression-free survival difference of PD-1 inhibitor+radiotherapy and PD-1 inhibitor alone [Time frame: 3-year]
Secondary outcome measures (3)
  • 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]

Eligibility 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%

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Shanghai cancer center — Shanghai

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 PMID 40734507

Identifiers

NCT: NCT06190782 · ESO-Shanghai20

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗