Adding PD-1 inhibitors to neoadjuvant chemoradiotherapy has shown promising results in
locally advanced resectable esophageal squamous cell carcinoma (ESCC). However, there is a
need to explore safer and more effective treatment doses and schedules. This is an open
labeled, prospective, single-arm phase II trial to evaluate the safety and efficacy of the
short course neoadjuvant chemo-radiotherapy plus Toripalimab for locally advanced resectble
Although neoadjuvant chemoradiotherapy (CRT) followed by surgery has become the standard
treatment option for locally advanced ESCC, prognosis of these patients is still poor. Adding
PD-1/PD-L1 checkpoints inhibitor to neoadjuvant chemoradiotherapy (CRT) have shown potential
benefit in locally advanced resectble ESCC. However, the conventional radiation dose may lead
to irreversible toxicity. There is need to explore more effective and safer treatment doses
and schedules for this combination.
The investigators proposed a novel strategy (short course neoadjuvant radiotherapy plus
preoperative chemotherapy and toripalimab, the SCALE strategy) for the treatment of locally
advanced resectble ESCC. In the phase Ib SCALE-1 (ChCTR2100045104) study, 23 patients were
enrolled and 20 patients had undergone surgery after the preoperative treatment. The
preliminary results showed that the SCALE strategy was safe and induced a pCR and MPR in 55%
and 80% of resected tumors, respectively. In this prospective, phase II study, the
investigators will further evaluate the safety and efficacy of the SCALE strategy in locally
advanced resectble ESCC. This study will provide valuable information for further clinical
use of SCALE strategy in locally advanced resectble ESCC.
Locally Advanced Esophageal Carcinoma
Short Course Neoadjuvant Radiotherapy
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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