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Spots Global Cancer Trial Database for Concurrent Chemoradiotherapy for Stage IVB Esophageal Squamous Cell Carcinoma(EC-CRT-003)

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Trial Identification

Brief Title: Concurrent Chemoradiotherapy for Stage IVB Esophageal Squamous Cell Carcinoma(EC-CRT-003)

Official Title: Systemic Therapy Combined With Thoracic Concurrent Chemoradiotherapy Versus Systemic Therapy Alone in Stage IVB Esophageal Squamous Cell Carcinoma: A Prospective Randomized Phase II Study

Study ID: NCT05512520

Study Description

Brief Summary: Retrospective studies suggested that the addition of thoracic concurrent chemoradiotherapy to systemic chemotherapy improved the survival and quality of life (QOL) of patients with metastatic esophageal squamous cell carcinoma (ESCC). However, no prospective study had been conducted to confirm these findings. Recently, immunotherapy targeting the PD-1/PD-L1 checkpoints combined with chemotherapy had been proved to significantly prolong the survival of those patients compared with chemotherapy alone. Moreover, anti-PD-1 combined with radiotherapy exerts a synergistic anti-tumor effect, which may further improve the combination efficacy. This randomized, phase II study aimed to evaluate the efficacy and safety of the chemotherapy and anti-PD-1 combined with concurrent chemoradiotherapy to primary tumor versus systemic therapy alone in stage IVB ESCC. Of note, non-regional lymph node metastasis only was the stratification factor in the random assignment.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Sun yat-sen University Cancer center, Guangzhou, Guangdong, China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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