Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06385730
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-04-23
Brief Title:
Neoadjuvant PD-1 Blockade for Elderly Esophageal Squamous Cell Carcinoma BLESS
Sponsor:
Shanghai Chest Hospital
Organization:
Shanghai Chest Hospital
Study Overview
Official Title:
Neoadjuvant PD-1 Blockade Toripalimab Monotherapy for Elderly Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma a Phase II Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BLESS
Brief 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
Detailed Description:
The incidence and mortality rates of esophageal cancer both rapidly increase after the age of 40 to 50 and peak after the age of 70 to 80 Clinical studies have shown that over 50 of esophageal cancer patients are diagnosed at an advanced local stage Currently the standard treatment recommended by guidelines for locally advanced esophageal cance is neoadjuvant chemoradiotherapy or chemotherapy However the phase III randomized controlled trials upon which these recommendations are based did not include patients over 75 years old Therefore for elderly patients aged over 75 with locally advanced esophageal cancer there remains a lack of high-level evidence-based optimal neoadjuvant treatment strategies in clinical practice
In Japan neoadjuvant chemotherapy combined with surgery is the standard treatment for locally advanced esophageal cancer A retrospective analysis PMID 35837977 conducted at 85 esophageal cancer centers certified by the Japan Esophageal Society examined patients with esophageal squamous cell carcinoma who received neoadjuvant CF cisplatin 5-fluorouracil or intensified neoadjuvant DCF docetaxel cisplatin 5-fluorouracil regimens The study results showed that the survival benefit of intensified neoadjuvant DCF was limited to patients aged 75 years In patients older than 75 years no survival advantage of intensified neoadjuvant DCF was observed and the incidence of postoperative pneumonia was higher The study suggested that elderly patients may not tolerate the toxic side effects of intensified neoadjuvant DCF triplet therapy The high-intensity neoadjuvant triplet chemotherapy increased the incidence of postoperative complications in esophageal cancer possibly offsetting the survival benefit in terms of tumor eradication
A phase 1 trial conducted in 2023 PMID 37488287 demonstrated that neoadjuvant single-agent immunotherapy atezolizumab for locally advanced resectable esophageal squamous cell carcinoma is safe with no Grade 3 or higher adverse reactions The primary pathological response rate was 24 with a complete pathological response rate of 8 The 2-year overall survival rate was 92 and the 2-year recurrence-free survival rate reached 100 When compared with a historical control study CMISG1701 study the 2-year recurrence-free survival rate and 2-year overall survival rate with neoadjuvant single-agent immunotherapy were significantly higher showing a statistically significant improvement compared to both standard neoadjuvant chemoradiotherapy 61 vs 69 and standard neoadjuvant chemotherapy 63 vs 67
Based on 1 clinical evidence indicating higher adverse reactions and limited benefits of high-intensity neoadjuvant treatment regimens in elderly esophageal squamous cell carcinoma patients and 2 the potential advantages of neoadjuvant single-agent immunotherapy over standard neoadjuvant chemoradiotherapy or chemotherapy in terms of safety and survival benefits this trial reasonably proposes a scientific research proposal-to explore the efficacy and safety of neoadjuvant immunotherapy monotherapy in elderly aged over 75 patients with locally advanced thoracic esophageal squamous cell carcinoma under conditions of reduced combination therapy and decreased adverse reactions
In Japan neoadjuvant chemotherapy combined with surgery is the standard treatment for locally advanced esophageal cancer A retrospective analysis PMID 35837977 conducted at 85 esophageal cancer centers certified by the Japan Esophageal Society examined patients with esophageal squamous cell carcinoma who received neoadjuvant CF cisplatin 5-fluorouracil or intensified neoadjuvant DCF docetaxel cisplatin 5-fluorouracil regimens The study results showed that the survival benefit of intensified neoadjuvant DCF was limited to patients aged 75 years In patients older than 75 years no survival advantage of intensified neoadjuvant DCF was observed and the incidence of postoperative pneumonia was higher The study suggested that elderly patients may not tolerate the toxic side effects of intensified neoadjuvant DCF triplet therapy The high-intensity neoadjuvant triplet chemotherapy increased the incidence of postoperative complications in esophageal cancer possibly offsetting the survival benefit in terms of tumor eradication
A phase 1 trial conducted in 2023 PMID 37488287 demonstrated that neoadjuvant single-agent immunotherapy atezolizumab for locally advanced resectable esophageal squamous cell carcinoma is safe with no Grade 3 or higher adverse reactions The primary pathological response rate was 24 with a complete pathological response rate of 8 The 2-year overall survival rate was 92 and the 2-year recurrence-free survival rate reached 100 When compared with a historical control study CMISG1701 study the 2-year recurrence-free survival rate and 2-year overall survival rate with neoadjuvant single-agent immunotherapy were significantly higher showing a statistically significant improvement compared to both standard neoadjuvant chemoradiotherapy 61 vs 69 and standard neoadjuvant chemotherapy 63 vs 67
Based on 1 clinical evidence indicating higher adverse reactions and limited benefits of high-intensity neoadjuvant treatment regimens in elderly esophageal squamous cell carcinoma patients and 2 the potential advantages of neoadjuvant single-agent immunotherapy over standard neoadjuvant chemoradiotherapy or chemotherapy in terms of safety and survival benefits this trial reasonably proposes a scientific research proposal-to explore the efficacy and safety of neoadjuvant immunotherapy monotherapy in elderly aged over 75 patients with locally advanced thoracic esophageal squamous cell carcinoma under conditions of reduced combination therapy and decreased adverse reactions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None