Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05737563
Status:
RECRUITING
Last Update Posted:
2024-01-23
First Post:
2023-02-12
Brief Title:
PD-1 Antibody Combined With mXELIRI Versus mXELIRI in the Second-line Setting for ESCC
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Phase III Randomized Multicenter Study of PD-1 Antibody Combined With mXELIRI Versus mXELIRI in the Second-line Treatment of Metastatic Esophageal Squamous Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-01
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:
Escape
Brief Summary:
This trial is a prospective multicenter randomized controlled trial The sample size was 380 Patients with advanced or metastatic esophageal squamous cell carcinoma will be randomized to receive PD1 antibody combined with mXELIRI or mXELIRI regimens in a 11 ratio The stratification factors include PS status 0 vs 1 PFS of first-line treatment PFS 3 months versus PFS 3 months Six cycles of chemotherapy are planned every 3 weeks for a total of 18 weeks after which the investigator can decide whether to provide capecitabine with or without PD1 antibody maintenance therapy Efficacy assessments were performed every 6 weeks before disease progression during treatment Survival status was followed every 3 months after disease progression
Detailed Description:
Esophageal cancer is the seventh most common cancer and the sixth most common cause of cancer related death worldwide Globally there were 604000 new cases of esophageal cancer and 544000 deaths in 2020 China is in the high incidence area of esophageal cancer with 253000 new cases of esophageal cancer and 194000 deaths in 2016 Esophageal cancer has become a malignant disease that seriously endangers the health and social development
Squamous cell carcinoma and adenocarcinoma are common pathological types of esophageal cancer The main risk factors for esophageal squamous cell carcinoma are smoking and alcohol consumption Esophageal squamous cell carcinoma is the most important pathological type of esophageal cancer in China accounting for more than 90 of esophageal cancer
The prognosis of esophageal cancer is very poor most patients are in the middle and advanced stages at the time of diagnosis The natural course of the disease is only 6-8 months and the 5-year survival rate is less than 20 In addition 90 of patients undergoing surgery may have recurrent metastasis and even those with very early staging T1 still have the risk of relapse or metastasis within 5 years Therefore in recent years scholars from various countries have continued to explore effective treatment methods in order to improve the quality of life and prolong the survival of esophageal cancer patients
Palliative chemotherapy is the mainstay of treatment for advanced metastatic esophageal cancer including paclitaxel platinum fluorouracil or irinotecan Multiple phase III clinical studies have shown that PD-1 antibodies in addition to PF fluorouracil plus cisplatin or TP paclitaxel plus cisplatin regimens can improve the effective rate and prolong PFS and OS Therefore PD-1 antibody combined with chemotherapy has become the new standard first-line treatment for patients with advanced esophageal cancer
Prior to the advent of PD-1 antibodies the second-line regimen for advanced esophageal cancer was to select drugs that were not used in first-line chemotherapy such as taxans or irinotecans Keynote181 Attraction-03 and ESCORT studies have suggested that PD-1 antibody monotherapy is superior to standard chemotherapy in the second-line treatment of advanced esophageal cancer In ESCORT studies PD-1 antibodies and conventional chemotherapy docetaxel or irinotecan were 202 percent and 64 percent effective median PFS at 19 months and median OS at 83 months and 62 months respectively Based on the above research results Chinas Food and Drug Administration has approved PD-1 antibody for the second-line treatment of advanced esophageal cancer
Therefore we intend to design a prospective multicenter randomized controlled clinical study based on the characteristics of esophageal cancer in China explore the efficacy and safety of PD-1 antibody combined with mXELIRI compared with mXELIRI in the second-line treatment of metastatic esophageal squamous cell carcinoma We will further analyze the significance of cross-line use of PD-1 antibody and analyze the possible benefit population
Squamous cell carcinoma and adenocarcinoma are common pathological types of esophageal cancer The main risk factors for esophageal squamous cell carcinoma are smoking and alcohol consumption Esophageal squamous cell carcinoma is the most important pathological type of esophageal cancer in China accounting for more than 90 of esophageal cancer
The prognosis of esophageal cancer is very poor most patients are in the middle and advanced stages at the time of diagnosis The natural course of the disease is only 6-8 months and the 5-year survival rate is less than 20 In addition 90 of patients undergoing surgery may have recurrent metastasis and even those with very early staging T1 still have the risk of relapse or metastasis within 5 years Therefore in recent years scholars from various countries have continued to explore effective treatment methods in order to improve the quality of life and prolong the survival of esophageal cancer patients
Palliative chemotherapy is the mainstay of treatment for advanced metastatic esophageal cancer including paclitaxel platinum fluorouracil or irinotecan Multiple phase III clinical studies have shown that PD-1 antibodies in addition to PF fluorouracil plus cisplatin or TP paclitaxel plus cisplatin regimens can improve the effective rate and prolong PFS and OS Therefore PD-1 antibody combined with chemotherapy has become the new standard first-line treatment for patients with advanced esophageal cancer
Prior to the advent of PD-1 antibodies the second-line regimen for advanced esophageal cancer was to select drugs that were not used in first-line chemotherapy such as taxans or irinotecans Keynote181 Attraction-03 and ESCORT studies have suggested that PD-1 antibody monotherapy is superior to standard chemotherapy in the second-line treatment of advanced esophageal cancer In ESCORT studies PD-1 antibodies and conventional chemotherapy docetaxel or irinotecan were 202 percent and 64 percent effective median PFS at 19 months and median OS at 83 months and 62 months respectively Based on the above research results Chinas Food and Drug Administration has approved PD-1 antibody for the second-line treatment of advanced esophageal cancer
Therefore we intend to design a prospective multicenter randomized controlled clinical study based on the characteristics of esophageal cancer in China explore the efficacy and safety of PD-1 antibody combined with mXELIRI compared with mXELIRI in the second-line treatment of metastatic esophageal squamous cell carcinoma We will further analyze the significance of cross-line use of PD-1 antibody and analyze the possible benefit population
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