RecruitingPhase 3NCT06190782

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

Sponsor

Fudan University

Enrollment

354 participants

Start Date

Sep 27, 2022

Study Type

INTERVENTIONAL

Conditions

Esophageal Squamous Cell Carcinoma Oligometastatic Disease Radiotherapy

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding targeted local radiation or surgery to treat a small number of metastatic sites (called oligometastatic disease) improves outcomes for people with esophageal squamous cell cancer who are already receiving immunotherapy (PD-1 inhibitors). **You may be eligible if...** - You are 18 or older with good general health (ECOG 0–1) - You have esophageal squamous cell carcinoma with a limited number of metastases (4 or fewer distant, 3 or fewer in any one organ, each ≤5 cm) - At least one of your metastases has been confirmed by biopsy **You may NOT be eligible if...** - Your cancer had previously spread widely before becoming oligometastatic - You have had esophageal perforation or bleeding - Your cancer progressed while on PD-1 inhibitor therapy - You cannot tolerate chemotherapy or immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTPD-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 (albumin-bound paclitaxel or paclitaxel liposomes as alternative of paclitaxel permitted as alternatives) 2. Local therapy i. Radiotherapy GTV=all suspected lesions. SBRT: for lung, liver, adrenal gland, celiac lymphnode metatstases 48Gy/6fx; for spine metastatic disease 30Gy/10Fx; for brain metastases 24Gy/30fx; IMRT: for bone metastatic disease 30Gy/10fx; for esophageal lesion or lesion unsuitable of SBRT 50.4Gy/28fx; ii. Surgery iii. Radiofrequency/microwave ablation

DRUGsystemic therapy alone