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

Fudan University

Status and phase: Enrolling; Phase 3

Conditions: Oligometastatic Disease; Radiotherapy; Esophageal Squamous Cell Carcinoma

Treatments: Drug: systemic therapy alone; Combination Product: PD-1 inhibitor+/- chemotherapy combined with local therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06190782

ESO-Shanghai20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 354 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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354 participants in 2 patient groups

PD-1 inhibitor+/- chemotherapy combined with local therapy

Experimental group

Description:

Patients randomized to this arm will receive local treatment combined with systemic treatment (immunotherapy or chemo-immunotherapy)

Treatment:

Combination Product: PD-1 inhibitor+/- chemotherapy combined with local therapy

PD-1 inhibitor +/- chemotherapy alone

Active Comparator group

Description:

Patients randomized to this arm will receive only systemic treatment (immunotherapy or chemo-immunotherapy)

Treatment:

Drug: systemic therapy alone