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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is 45 to 50.4Gy in 25 to 28 fractions, concurrently with 2 cycles of capecitabine tablets (825mg/m2) for two weeks.
Sun yat-sen University Cancer center
Guangzhou, Guangdong, China
RECRUITING1-year progression-free survival
The 1-year progression-free survival of each group
Time frame: From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 12 months
1-year overall survival
The 1-year overall survival of the each group
Time frame: From date of randomization until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 12 months
ORR
Overall response rate
Time frame: 3 months after chemoradiotherapy (plus or minus 14 days)
Treatment-related adverse events
Toxicity of treatment was evaluated according to CTCAE 4.0
Time frame: From the start of treatment to 2 year after the completion of treatment
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