NCT04644250

Combination of Toripalimab and Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

Phase II of Toripalimab Chemoradiotherapy in Neoadjuvant Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma: A Single-center、Open Lable、Single-arm Exploratory Clinical Research

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Wei Ren · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Radical resection is thought to be the mainstay of esophageal cancer treatment. Neoadjuvant chemoradiotherapy (CRT) followed by surgery has become the standard treatment option for locally advanced esophageal squamous cell cancer (ESCC). However, only 20% to 40% of patients can achieve pathologic complete response (pCR) after neoadjuvant CRT with favorable prognosis and about 10% of patients have disease progression after chemoradiotherapy. How to improve the the efficacy of neoadjuvant therapy is an important clinical problem to be solved. Immunotherapy targeting the programmed cell death receptor-1（PD-1） /programmed cell death-Ligand 1(PD-L1) checkpoints has demonstrated promising activity in ESCC. In Keynote181 study, for patients with metastatic esophageal squamous cell carcinoma, regardless of PD-L1 expression, pembrolizumab significantly improved overall survival compared with chemotherapy. However, the efficacy and safety of immunotherapy therapy in surgery-based multidisciplinary treatment of local advanced esophageal cancer still need a lot of clinical studies to further confirm. This study aims to investigate the safety and efficacy of Toripalimab combined with radiotherapy and chemotherapy in neoadjuvant treatment of locally advanced esophageal squamous cell carcinoma

Detailed description

This study was designed as an open-lable, single-arm, single-center,exploratory clinical study. Toripalimab combination of chemoradiotherapy as neoadjuvant therapy. Participants will receive carboplatin (AUC=2) and paclitaxel liposome (50mg/m²) on day 3,10,17,24,31. And radiotherapy Intensity-modulated radiation therapy（IMRT）will start from day 1 to 31 of chemotherapy. A total of 41.4 Gy, 23 fractions of 1.8 Gy. Participants will also receive Toripalimab (240mg) on days 3, 24and 45. After the neoadjuvant treatment is over, the short-term efficacy evaluation will be performed first, and then a radical resection will be scheduled on Day 59 to 73. This study include 2 phases: 14 cases were enrolled in the first stage and 18 cases were enrolled in the second stage.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Toripalimab	Participants will also receive Toripalimab(240mg) VD 30 min on days 3, 24 and 45，3 cycles in total.
DRUG	Paclitaxel liposome/Carboplatin	Participants will receive carboplatin (AUC=2) VD 30min and paclitaxel liposome (50mg/m²) CIV 24h on day 3,10,17,24,31, 5cycles in total.
RADIATION	Intensity-modulated radiotherapy	A total of 41.4 Gy, 23 fractions of 1.8 Gy on Day 1 to 31.

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-03-01
• Completion: 2024-03-01
• First posted: 2020-11-25
• Last updated: 2020-11-25

Locations

1 site across 1 country: China