NCT04006041

Combination of Toripalimab and Neoadjuvant Chemoradiotherapy in Esophageal Cancer

A Phase II Trial of Combination of Toripalimab and Neoadjuvant Chemoradiotherapy in Esophageal Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Jianhua Fu · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Neoadjuvant chemoradiotherapy (CRT) followed by surgery has become the standard treatment option for locally advanced esophageal cancer (EC). However, only 20% to 40% of EC patients can achieve pathologic complete response (pCR) after neoadjuvant CRT with favorable prognosis. Immunotherapy targeting the PD-1/PD-L1 checkpoints has demonstrated promising activity in advanced EC. The aim of this study was to evaluate the efficacy and safety of the combination of toripalimab (an anti-PD-1 antibody) combined with neoadjuvant CRT in locally advanced esophageal squamous cell carcinoma (ESCC).

Conditions

• Esophageal Squamous Cell Carcinoma by AJCC V8 Stage
• Resectable Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Toripalimab	Patients received toripalimab 240 mg IVDRIP on days 1 and 22 during neoadjuvant radiotherapy.
DRUG	Paclitaxel/cisplatin	Patients received 4 cycles of paclitaxel/cisplatin (paclitaxel 50mg/m2 and cisplatin 25 mg/m2) on days 1, 8, 15, 22 during neoadjuvant radiotherapy.
RADIATION	Intensity-modulated radiotherapy	All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is 44 Gy in 20 fractions over 4 weeks.
PROCEDURE	Esophagectomy	A transthoracic (Ivor-Lewis) esophagectomy is performed 6-8 weeks after CRT completion.

Timeline

• Start date: 2019-06-25
• Primary completion: 2020-06-30
• Completion: 2020-12-31
• First posted: 2019-07-02
• Last updated: 2019-12-26

Locations

1 site across 1 country: China