RecruitingPhase 2NCT06385730

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

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

Sponsor

Shanghai Chest Hospital

Enrollment

60 participants

Start Date

Jun 17, 2024

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer

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).

Eligibility

Min Age: 76 Years

Plain Language Summary

Simplified for easier understanding

This study (BLESS) is testing immunotherapy (a PD-1 blocking drug) given before surgery in elderly patients (over 75) with resectable esophageal squamous cell carcinoma, to see if it improves surgical outcomes and survival in this age group. **You may be eligible if...** - You are over 75 years old - You have esophageal squamous cell carcinoma confirmed by biopsy - Your cancer is at a stage that can potentially be surgically removed (T1N1-3M0 or T2-3N0-3M0) - You have not had any prior treatment for your esophageal cancer - You are in good enough health for surgery **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have autoimmune disease or active infections (HIV, hepatitis B, tuberculosis) - You have had recent heart problems (heart failure, unstable angina, heart attack within 1 year) - You are pregnant or breastfeeding - You have received immune-suppressing steroids or live vaccines recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGneoadjuvant 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

DRUGneoadjuvant 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