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RECRUITING
NCT06385730
PHASE2

Neoadjuvant PD-1 Blockade for Elderly Esophageal Squamous Cell Carcinoma (BLESS)

Sponsor: Shanghai Chest Hospital

View on ClinicalTrials.gov

Summary

The investigators will conduct a prospective phase 2 study to evaluate the efficacy and safety of neoadjuvant PD-1 blockade monotherapy with toripalimab in elderly patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC).

Official title: Neoadjuvant PD-1 Blockade (Toripalimab) Monotherapy for Elderly Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: a Phase II Trial

Key Details

Gender

All

Age Range

76 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-06-17

Completion Date

2027-05

Last Updated

2024-07-01

Healthy Volunteers

No

Interventions

DRUG

neoadjuvant anti-PD-1

PD-1 inhibitor (toripalimab) 240mg, day 1,every 3 weeks, 2 cycles. Postoperative adjuvant treatment: according to the recommendations of the guidelines and the investigators

DRUG

neoadjuvant anti-PD-1 with LDRT

Radiotherapy: low-dose radiotherapy (LDRT), gross target volume (GTV), DT: 1Gy (day1), 1Gy (day2), every 3 weeks, 2 cycles. PD-1 inhibitor (toripalimab) 240mg, day 3,every 3 weeks, 2 cycles. Postoperative adjuvant treatment: according to the recommendations of the guidelines and the investigators

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China