Ignite Creation Date:
2024-07-17 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464614
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-13
Brief Title:
Adebrelimab in Combination With Apatinib and ChemotherapyChemoradiotherapy in Immuno-experienced Second-line ESCC
Sponsor:
The First Affiliated Hospital of Henan University of Science and Technology
Organization:
The First Affiliated Hospital of Henan University of Science and Technology
Study Overview
Official Title:
A Double-arm Non-randomized Controlled Open-label Clinical Study of Adebrelimab in Combination With Apatinib and ChemotherapyChemoradiotherapy in Immuno-experienced Second-line Esophageal Squamous Cell Carcinoma
Status:
NOT_YET_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:
None
Brief Summary:
To assess the efficacy and safety of adebrelimab in combination with apatinib mesylate and chemoradiotherapy in immuno-experienced second-line esophageal squamous cell carcinoma with symptomatic dysphagia or oligometastatic diseaseand to evaluate the efficacy and safety of adebrelimab in combination with apatinib mesylate and chemoradiotherapy in immuno-experienced second-line esophageal squamous cell carcinoma without symptomatic dysphagia or oligometastatic disease
Detailed Description:
The treatment of advanced second-line esophageal squamous cell carcinoma has always been mainly chemotherapy Since 2019 a number of phase III clinical trials ESCORT KEYNOTE-181 RATIONALE 302 ATRACTION-3 etc have confirmed that there is a significant difference in OS between the immune monotherapy group and the chemotherapy group and immunotherapy can bring better survival benefits Although the above studies have brought new possibilities for second-line patients with advanced esophageal cancer the results of the study show that the response rate of immune monotherapy is limited with a single-agent ORR of about 13-20 mPFS of about 2 months and mOS about 8 months Therefore finding a suitable combination therapy model to further improve the efficacy of advanced second-line esophageal cancer has gradually become a research hotspot in recent years In recent years many experts have also made a lot of explorations The combination of anti-angiogenic drugs and immunotherapy drugs can be synergistic
Dysphagia is a major symptom in patients with esophageal cancer leading to significant nutritional deficiencies pain and subsequent deterioration in quality of life Management of dysphagia is a key goal of esophageal cancer treatment along with the need to improve nutritional status and quality of life which may have a positive impact on the overall prognosis of patients Current treatment methods for dysphagia include esophageal dilation endoluminal stenting systemic chemotherapy external beam radiotherapy EBRT brachytherapy and concurrent chemoradiotherapy CTRT At present there is no consensus on how to better manage this symptom with these treatment regimens and more research is needed to continue to explore
To assess the efficacy and safety of adebrelimab in combination with apatinib mesylate and chemoradiotherapy in immuno-experienced second-line esophageal squamous cell carcinoma with symptomatic dysphagia or oligometastatic disease and to evaluate the efficacy and safety of adebrelimab in combination with apatinib mesylate and chemoradiotherapy in immuno-experienced second-line esophageal squamous cell carcinoma without symptomatic dysphagia or oligometastatic disease
Dysphagia is a major symptom in patients with esophageal cancer leading to significant nutritional deficiencies pain and subsequent deterioration in quality of life Management of dysphagia is a key goal of esophageal cancer treatment along with the need to improve nutritional status and quality of life which may have a positive impact on the overall prognosis of patients Current treatment methods for dysphagia include esophageal dilation endoluminal stenting systemic chemotherapy external beam radiotherapy EBRT brachytherapy and concurrent chemoradiotherapy CTRT At present there is no consensus on how to better manage this symptom with these treatment regimens and more research is needed to continue to explore
To assess the efficacy and safety of adebrelimab in combination with apatinib mesylate and chemoradiotherapy in immuno-experienced second-line esophageal squamous cell carcinoma with symptomatic dysphagia or oligometastatic disease and to evaluate the efficacy and safety of adebrelimab in combination with apatinib mesylate and chemoradiotherapy in immuno-experienced second-line esophageal squamous cell carcinoma without symptomatic dysphagia or oligometastatic disease
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