Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563869
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Sintilimab With Chemotherapy Plus PEG-rhG-GSF for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Sintilimab in Combination With Platinum-containing Chemotherapy Plus PEG-rhG-GSF for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma a Prospective Open Single-arm Single-center Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective open-label single-arm single-center clinical study aiming to evaluate the efficacy and safety of sintilimab combined with platinum-based chemotherapy pegylated recombinant human granulocyte stimulating factor as neoadjuvant treatment for resectable esophageal squamous cell carcinoma patients In the study all patients who meet the inclusion criteria will receive sintilimab combined with platinum-based chemotherapy for 2 cycles 21 days as one cycle as neoadjuvant treatment according to the study plan Pegylated recombinant human granulocyte stimulating factor will be given 24 hours after the end of chemotherapy and radical surgical treatment will be received within 3-6 weeks after the completion of the last neoadjuvant treatment Whether the subjects need adjuvant treatment after surgery and the adjuvant treatment plan will be determined by the investigators All subjects need to complete the follow-up plan formulated by the study after surgery
Detailed Description:
The patients selected for the study were those who were diagnosed with esophageal cancer for the first time The recruited subjects should be
1 Preoperatively the main part of the tumor was located in the middle and lower part of the esophagus below 18 cm from the incisors as shown by gastroscopy and the pathological type was squamous cell carcinoma as shown by biopsy
2 Preoperatively patients with esophageal cancer assessed by imaging CT MRI or PETCT cervical B-ultrasound and endoscopic ultrasound as potentially resectable Potentially resectable patients were defined as those with T2-4aNxM0 stage II-IVA AJCC staging 8th edition 2017 of esophageal cancer according to the 2022 Guidelines for the Diagnosis and Treatment of Esophageal Cancer of the Chinese Society of Clinical Oncology For T2N0M0 the length of the primary tumor under endoscopic examination was required to be 2 cm located below the neck and 5 cm away from the cricopharyngeal muscle
3 Signed the informed consent form and met all the inclusion and exclusion criteria of this study
1 Preoperatively the main part of the tumor was located in the middle and lower part of the esophagus below 18 cm from the incisors as shown by gastroscopy and the pathological type was squamous cell carcinoma as shown by biopsy
2 Preoperatively patients with esophageal cancer assessed by imaging CT MRI or PETCT cervical B-ultrasound and endoscopic ultrasound as potentially resectable Potentially resectable patients were defined as those with T2-4aNxM0 stage II-IVA AJCC staging 8th edition 2017 of esophageal cancer according to the 2022 Guidelines for the Diagnosis and Treatment of Esophageal Cancer of the Chinese Society of Clinical Oncology For T2N0M0 the length of the primary tumor under endoscopic examination was required to be 2 cm located below the neck and 5 cm away from the cricopharyngeal muscle
3 Signed the informed consent form and met all the inclusion and exclusion criteria of this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None