NCT05424432

Short Course Neoadjuvant Chemo-radiotherapy Plus Toripalimab for Locally Advanced Resectble Squamous Cell Carcinoma of Esophagus

Short Course Neoadjuvant Chemo-radiotherapy Plus Anti-PD-1 Antibody (Toripalimab) for Locally Advanced Resectble Squamous Cell Carcinoma of Esophagus (SCALE-2）

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Jiangsu Cancer Institute & Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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 ESCC.

Detailed description

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.

Conditions

• Locally Advanced Esophageal Carcinoma

Interventions

Type	Name	Description
DRUG	Neoadjuvant Chemotherapy	Paclitaxel (135 mg /m2) and carboplatin (AUC=5) every 3 weeks for two cycles (D1,D22)
DRUG	Neoadjuvant Toripalimab	Toripalimab 240mg every 3 weeks for two cycles (D2,D23)
RADIATION	Short Course Neoadjuvant Radiotherapy	30 Gy in 12 fractions, 1 fraction per day, 5 days per week, D3-D18

Timeline

• Start date: 2022-04-29
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2022-06-21
• Last updated: 2022-06-27

Locations

1 site across 1 country: China