Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05743504
Status:
RECRUITING
Last Update Posted:
2024-02-02
First Post:
2023-01-30
Brief Title:
Immunotherapy With CCRT Followed by Surgery for Locally Advanced ESCC Patients
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
A Phase IbII Trial of Neoadjuvant Tiragolumab Atezolizumab Paclitaxel Cisplatin and Radiotherapy Followed by Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2023-09
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:
None
Brief Summary:
The prognosis of ESCC is poor with a five-year overall survival rate of 10 to 30 Randomized clinical trials have demonstrated that TMT consisted of neoadjuvant concurrent CCRT and radical esophagectomy improves the overall survival for patients with resectable locally advanced disease As a consequence it is mandatory to develop new pharmacotherapeutic regimen for TMT In our previous prospective studies we found higher levels of serum immune-related biomarkers VEGF-A TGF-β1 and soluble PD-L1 before neoadjuvant CCRT were independent associated with inferior overall survival and disease-free survival for locally advanced ESCC treated with neoadjuvant CCRT plus radical esophagectomy In the present clinical trial we plan to investigate whether incorporation of tiragolumab Anti-TIGIT and atezolizumab Anti-PD-L1 into standard TMT will be safe while improve the pathological complete response rate By the present research we expect to develop a new TMT regimen for this poor prognostic disease
Detailed Description:
Esophageal squamous cell carcinoma ESCC is one of the most lethal malignancy worldwide The prognosis is poor with a five-year overall survival rate of 10 to 30 Randomized clinical trials have demonstrated that trimodality therapy TMT consisted of neoadjuvant concurrent chemoradiation CCRT and radical esophagectomy improves the overall survival for patients with resectable locally advanced disease Despite of the advancement the outcome remained unsatisfactory with the median recurrence-free survival around 20 to 25 months and median overall survival around 30 months It is known that the most important prognostic factor is whether a pathological complete response can be achieved after neoadjuvant CCRT However the use of new generation chemotherapeutic agent and epidermal growth factor inhibitors failed to significantly improve prognosis comparing to the standard platinum-based regimen As a consequence it is mandatory to develop new pharmacotherapeutic regimen for TMT
In our previous prospective studies we found higher levels of serum immune-related biomarkers VEGF-A TGF-β1 and soluble PD-L1 before neoadjuvant CCRT were independent associated with inferior overall survival and disease-free survival for locally advanced ESCC treated with neoadjuvant CCRT plus radical esophagectomy Recent clinical trials have shown the efficacy of anti-PD-1 in recurrentmetastatic ESCC Besides preclinical and clinical studies suggested radiotherapy might induce local inflammatory stimulus for the immune modulating drug to boost the integrated response In addition preclinical study showed promising anti-cancer efficacy by combination of fractionated radiotherapy anti-PD-L1 andor anti-TIGIT immunotherapy Though several prospective clinical trials have shown the feasibility safety and activity of adding anti-TIGIT therapy to anti-PD-L1 drug and adding anti-PD-L1 therapy to chemotherapy in lung cancer the safety and activity of combing anti-PD-1PD-L1 to CCRT or TMT remained largely undetermined In the present clinical trial we plan to investigate whether incorporation of tiragolumab Anti-TIGIT and atezolizumab Anti-PD-L1 into standard TMT will be safe while improve the pathological complete response rate By the present research we expect to develop a new TMT regimen for this poor prognostic disease
This study is a single arm open labeled trial to evaluate the safety and pathological response of ESCC patients receiving neoadjuvant PaclitaxelCisplatinTP-CCRT plus TiragolumabAtezolizumab followed by radical esophagectomy We design to enroll 32 patients to develop the preliminary evidence for incorporating tiragolumabatezolizumab in locally advanced ESCC
In our previous prospective studies we found higher levels of serum immune-related biomarkers VEGF-A TGF-β1 and soluble PD-L1 before neoadjuvant CCRT were independent associated with inferior overall survival and disease-free survival for locally advanced ESCC treated with neoadjuvant CCRT plus radical esophagectomy Recent clinical trials have shown the efficacy of anti-PD-1 in recurrentmetastatic ESCC Besides preclinical and clinical studies suggested radiotherapy might induce local inflammatory stimulus for the immune modulating drug to boost the integrated response In addition preclinical study showed promising anti-cancer efficacy by combination of fractionated radiotherapy anti-PD-L1 andor anti-TIGIT immunotherapy Though several prospective clinical trials have shown the feasibility safety and activity of adding anti-TIGIT therapy to anti-PD-L1 drug and adding anti-PD-L1 therapy to chemotherapy in lung cancer the safety and activity of combing anti-PD-1PD-L1 to CCRT or TMT remained largely undetermined In the present clinical trial we plan to investigate whether incorporation of tiragolumab Anti-TIGIT and atezolizumab Anti-PD-L1 into standard TMT will be safe while improve the pathological complete response rate By the present research we expect to develop a new TMT regimen for this poor prognostic disease
This study is a single arm open labeled trial to evaluate the safety and pathological response of ESCC patients receiving neoadjuvant PaclitaxelCisplatinTP-CCRT plus TiragolumabAtezolizumab followed by radical esophagectomy We design to enroll 32 patients to develop the preliminary evidence for incorporating tiragolumabatezolizumab in locally advanced ESCC
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ML43431 | OTHER_GRANT | F Hoffmann-La Roche Ltd | None |