Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426797
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-19
Brief Title:
Neoadjuvant Cadonilimab Combined With Anlotinib in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
Sponsor:
Peking University Peoples Hospital
Organization:
Peking University Peoples Hospital
Study Overview
Official Title:
Safety and Efficacy of Cadonilimab Combined With Anlotinib in Neoadjuvant Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma a Single Arm Phase II Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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 goal of this clinical trial is to learn if cadonilimab combined with anlotinib can be a safe and effective neoadjuvant therapy in patients with locally advanced resectable esophageal squamous cell carcinoma ESCC The main questions it aims to answer are
What level of pathological complete response pCR rate can be achieved with this neoadjuvant regimen Is this neoadjuvant regimen safe enough with acceptable toxicity
Participants will
Receive cadonilimab 10mgKg ivgtt d1 and anlotinib 12mg PO d1-d14 on a 21-day regimen for 3 cycles
Undertake radical resection of ESCC after neoadjuvant therapy if there is no surgical contraindication
Accept an follow-up for 2 years after surgery
What level of pathological complete response pCR rate can be achieved with this neoadjuvant regimen Is this neoadjuvant regimen safe enough with acceptable toxicity
Participants will
Receive cadonilimab 10mgKg ivgtt d1 and anlotinib 12mg PO d1-d14 on a 21-day regimen for 3 cycles
Undertake radical resection of ESCC after neoadjuvant therapy if there is no surgical contraindication
Accept an follow-up for 2 years after surgery
Detailed Description:
Esophageal cancer has a high incidence in China among which esophageal squamous cell carcinoma is the most common Neoadjuvant chemoradiotherapy combined with surgery is currently the recommended treatment modality for locally advanced esophageal cancer but the side effects of chemoradiotherapy are serious which increases the risk of surgery
Immune checkpoint inhibitors have made significant progress in the field of cancer treatment in recent years and have now become an important treatment method for advanced and metastatic esophageal cancer Several trials on neoadjuvant immuno-chemotherapy demonstrated better outcomes with acceptable toxicity compared to traditional chemoradiotherapy Cadonilimab is a dual immune antibody drug comprised of PD-1 antibody and CTLA-4 antibody which has the anti-tumor effect of two immune checkpoint pathways at the same time
On the other hand angiogenesis plays a vital role in the growth and metastasis of tumors and anti-angiogenic drugs have become an important part of cancer treatment Anlotinib is an oral small molecule anti-angiogenic targeted agent that has been approved for use in a variety of cancer treatments
This study plans to conduct a prospective study of cadonilimab combined with anlotinib in the neoadjuvant treatment of resectable esophageal squamous cell carcinoma and aims to explore the efficacy and safety of this neoadjuvant regimen that avoids chemoradiotherapy in locally advanced resectable esophageal squamous cell carcinoma
Immune checkpoint inhibitors have made significant progress in the field of cancer treatment in recent years and have now become an important treatment method for advanced and metastatic esophageal cancer Several trials on neoadjuvant immuno-chemotherapy demonstrated better outcomes with acceptable toxicity compared to traditional chemoradiotherapy Cadonilimab is a dual immune antibody drug comprised of PD-1 antibody and CTLA-4 antibody which has the anti-tumor effect of two immune checkpoint pathways at the same time
On the other hand angiogenesis plays a vital role in the growth and metastasis of tumors and anti-angiogenic drugs have become an important part of cancer treatment Anlotinib is an oral small molecule anti-angiogenic targeted agent that has been approved for use in a variety of cancer treatments
This study plans to conduct a prospective study of cadonilimab combined with anlotinib in the neoadjuvant treatment of resectable esophageal squamous cell carcinoma and aims to explore the efficacy and safety of this neoadjuvant regimen that avoids chemoradiotherapy in locally advanced resectable esophageal squamous cell carcinoma
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