RecruitingPhase 2NCT05978193

Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma

First-line Anti-PD-1 Therapy Plus Chemotherapy With or Without Radiotherapy in Metastatic Esophageal Squamous Cell Carcinoma: A Phase II Multi-center Trial (SCR-ESCC-01)

Sponsor

Shanghai Chest Hospital

Enrollment

100 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer Esophageal Squamous Cell Carcinoma Metastatic Esophageal Squamous Cell Carcinoma

Summary

SCR-ESCC-01 is a multicenter, randomized, phase II study aiming to investigate the benefit of early involvement of low-dose radiotherapy(LDRT) and conventionally fractionated radiotherapy(CFRT) in the first-line anti-PD-1 based treatment of metastatic ESCC. It begins with a safety run-in phase, followed by a randomized controlled comparison against standard immunochemotherapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining radiotherapy with chemotherapy and immunotherapy improves outcomes for patients with metastatic esophageal squamous cell carcinoma (cancer of the esophagus that has spread to other organs). **You may be eligible if...** - You are 18 or older - You have been diagnosed with metastatic (stage IVB) squamous cell carcinoma of the esophagus confirmed by biopsy - You have not received any prior anti-cancer treatment - You are in good health (ECOG performance status 0–1) - Your blood counts and organ function are adequate **You may NOT be eligible if...** - Your cancer is not squamous cell type (e.g., adenocarcinoma) - Your cancer could potentially be cured with surgery - You have cancer spread to the lining around the lungs (pleura) or fluid around the heart - You are at high risk of gastrointestinal bleeding or perforation 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

RADIATIONLDRT+CFRT

LDRT: Primary tumor and all visible metastatic lesions, DT: 2Gy/2fx, d1-2, Q3W × 4 cycles ; CFRT: Primary tumor, DT:40-50Gy/20-25fx, starting from the 5th immunotherapy cycle

DRUGImmunotherapy

PD-1 inhibitor 200mg, Q3W, until disease progression or unacceptable toxicity or treatment reaches 2 years

DRUGChemotherapy

Paclitaxel+ Cisplatin, Q3W × 4cycles or Paclitaxel+ Carboplatin, Q3W × 4 cycles

Locations(2)

Shanghai Ruijin Hospital

Shanghai, China

Shanghai Chest Hospital

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT05978193

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