Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339619
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-25
Brief Title:
Combination Immunotherapy of Adebrelimab With Apatinib and Tegafur for Immune Rechallenge Therapy in Esophageal Squamous Cell Carcinoma
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
Phase II Clinical Study of Adebrelimab Combined With Apatinib and Tegafur in the Treatment of Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma That Failed First-line Immunotherapy Combined With Chemotherapy
Status:
RECRUITING
Status Verified Date:
2024-03
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 single-arm study is to explore the efficacy and safety of Adebrelimab in combination with Apatinib and Tegafur for the treatment of locally advanced or metastatic esophageal squamous cell carcinoma that has failed first-line standard treatment with PD-1 inhibitors in combination with chemotherapy
Detailed Description:
Background Although immune combined chemotherapy has established its position as the first-line standard treatment for locally advanced unresectable or metastatic esophageal cancer resistance and disease progression inevitably occur in most patients While earlier studies have shown some therapeutic advantages of the combination of PD-1PDL1 inhibitors with anti-angiogenic drugs the efficacy as a second-line treatment remains unsatisfactory necessitating further exploration of combination therapies such as chemotherapyWe conduct this single-arm study is to explore the efficacy and safety of Adebrelimab in combination with Apatinib and Tegafur in treating the patients with locally advanced or metastatic esophageal squamous cell carcinoma who has failed first-line standard treatment with PD-1 inhibitors in combination with chemotherapy
Method This is a prospective single arm two-stage phase II study with an intended enrollment of 32 patients Eligible patients with esophageal squamous cell carcinoma will receive Adebrelimab at a dose of 20mgkg on day 1 via intravenous drip every 21 days in combination with Apatinib at a dose of 250mg orally once daily on days 1-21 every 21 days and Tegafur orally once daily on days 1-21 every 21 daysBSA125m240mg BSA12515m250mgBSA15m2 60mg Each treatment cycle lasts for 21 days Treatment will continue until disease progression intolerable toxicity withdrawal of informed consent or death Imaging evaluation for efficacy will be conducted every 6 to 8 weeks 7 days after the start of the initial treatment until disease progression death initiation of new anticancer therapy withdrawal of informed consent loss to follow-up or study termination The primary endpoint is objective response rate ORR and secondary endpoints include progression-free survival PFS overall survival OS disease control rate DCR and safety
Method This is a prospective single arm two-stage phase II study with an intended enrollment of 32 patients Eligible patients with esophageal squamous cell carcinoma will receive Adebrelimab at a dose of 20mgkg on day 1 via intravenous drip every 21 days in combination with Apatinib at a dose of 250mg orally once daily on days 1-21 every 21 days and Tegafur orally once daily on days 1-21 every 21 daysBSA125m240mg BSA12515m250mgBSA15m2 60mg Each treatment cycle lasts for 21 days Treatment will continue until disease progression intolerable toxicity withdrawal of informed consent or death Imaging evaluation for efficacy will be conducted every 6 to 8 weeks 7 days after the start of the initial treatment until disease progression death initiation of new anticancer therapy withdrawal of informed consent loss to follow-up or study termination The primary endpoint is objective response rate ORR and secondary endpoints include progression-free survival PFS overall survival OS disease control rate DCR and safety
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