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

Phase 3

Recruiting

• Conditions: Esophageal Squamous Cell Carcinoma; Oligometastatic Disease; Radiotherapy
• Interventions: Combination Product: PD-1 inhibitor+/- chemotherapy combined with local therapy; Drug: systemic therapy alone

• Registration Number: NCT06190782
• Lead Sponsor: Fudan University

Brief 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). 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 Timeline

• Study Start: 2022-09-27
• Study First Submitted: 2023-12-20
• Study First Submitted QC: 2023-12-20
• Study First Posted: 2024-01-05
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-02
• Primary Completion: 2025-09-27
• Study Completion: 2027-09-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 354

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PD-1 inhibitor+/- chemotherapy combined with local therapy	PD-1 inhibitor+/- chemotherapy combined with local therapy	Patients randomized to this arm will receive local treatment combined with systemic treatment (immunotherapy or chemo-immunotherapy)
PD-1 inhibitor +/- chemotherapy alone	systemic therapy alone	Patients randomized to this arm will receive only systemic treatment (immunotherapy or chemo-immunotherapy)

Primary Outcome Measures

Name	Time	Method
Progression-free survival difference of PD-1 inhibitor+radiotherapy and PD-1 inhibitor alone	3-year	The time between the start of the study treatment(day 1) and progression disease(PD)

Secondary Outcome Measures

Name	Time	Method
local control rate	1-year, 3-year	the portion of patients who do not develop progression disease or exacerbation of clinical symptoms despite stable disease
overall survival difference of PD-1 inhibitor+radiotherapy and PD-1 inhibitor alone	3-year	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
treatment related side effect	acute side effects within 3 months, late side effects for 3 months later	Record the treatment related side effects including acute and late side effects

Trial Locations

Locations (1)

Fudan University Shanghai cancer center; 🇨🇳 Shanghai, China