The goal of this phase II clinical trial is to explore the efficacy and safety of anti-PD1 combined with stereotactic body radiation therapy (SBRT) for patients with oligometastatic esophageal squamous cell carcinoma. Participants will receive anti-PD1 and SBRT to the metastatic lesions which are amenable to the delivery of SBRT after 4\~6 cycles of systemic chemotherapy and anti-PD-1.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Anti-PD1 monoclonal antibody combined with SBRT. The SBRT defined as the radiation prescription with single dose equal or over 4Gy and the fractions less or equal to 10 fractions. BED equal or over 50Gy is required.
Mian Xi
Guangzhou, Guangdong, China
RECRUITING1-year progression-free survival
1-year progression-free survival
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
1-year overall survival
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 SBRT (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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.