Ignite Creation Date:
2024-07-17 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489197
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-28
Brief Title:
AK112 Combined With Chemotherapy as the First-line Treatment in Advanced Esophageal Squamous Cell Carcinoma Patients
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
IvonescimabAK112 Combined With Chemotherapy as the First-line Treatment in Patients With Advanced Esophageal Squamous Cell Carcinoma ESCC A Single Arm Phase II Trial
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:
This is a single armphase 2 study evaluating the safety and efficacy of IvonescimabAK112 combined with chemotherapy in the treatment of advanced esophageal squamous cell carcinoma ESCC In this study patients with advanced esophageal squamous cell carcinoma who had not received any systematic treatment in the past will be enrolled
The research will be conducted in two stages In the first part 6 patients were enrolled in the group After the last subject in the group completed at least 21 days of observation after the first medication the researchers will conduct a preliminary safety and effectiveness assessment If the safety and tolerability are good it will enter the second expansion part till the study enrolled 30 patients Patients who met the inclusion criteria were treated with AK112 20mgkg intravenous infusion d1 Q3W in combination with albumin paclitaxel 220mgm2 intravenous infusion d1 Q3W and cisplatin 75mgm2 intravenous infusion d1 Q3W of which the maximum treatment time of chemotherapy was up to six cycles and the maximum treatment time of AK112 was 24 months Patients received regular and periodic reviews with imaging evaluations every 6 weeks
The research will be conducted in two stages In the first part 6 patients were enrolled in the group After the last subject in the group completed at least 21 days of observation after the first medication the researchers will conduct a preliminary safety and effectiveness assessment If the safety and tolerability are good it will enter the second expansion part till the study enrolled 30 patients Patients who met the inclusion criteria were treated with AK112 20mgkg intravenous infusion d1 Q3W in combination with albumin paclitaxel 220mgm2 intravenous infusion d1 Q3W and cisplatin 75mgm2 intravenous infusion d1 Q3W of which the maximum treatment time of chemotherapy was up to six cycles and the maximum treatment time of AK112 was 24 months Patients received regular and periodic reviews with imaging evaluations every 6 weeks
Detailed Description:
Part 1 Safety introduction phase evaluate the safety and tolerability of AK112 combined with chemotherapy albumin paclitaxel and cisplatin Plan to enroll 6 advanced ESCC subjects who have not undergone any systematic anti-tumor treatment in the past After completing at least 21 days of observation after the first medication of the last enrolled subject the researchers will conduct preliminary safety and efficacy evaluations If the safety and tolerability are good and preliminary therapeutic signals are observed it will enter the stage of expansion into the group Researchers may also discuss adjusting the AK112 dose albumin paclitaxel dose or cisplatin dose based on the specific situation during the DLT observation period and then enroll new subjects for the safety introduction phase evaluation of the treatment plan in the study group
DLT definition Within 21 days after the first administration the subject experiences the following drug-related toxic reactions according to NCI CTC AE 50 toxicity evaluation criteria hematological toxicity level 4 or above or non hematological toxicity level 3 or above excluding hair loss
Part 2 Expand the enrollment stage to further evaluate the efficacy and safety of AK112 combined with albumin paclitaxel and cisplatin in first-line treatment of advanced ESCC During the expansion phase 30 subjects will be enrolled and a comprehensive discussion will be conducted based on the safety and efficacy data from the safety introduction phase to determine the dosage
DLT definition Within 21 days after the first administration the subject experiences the following drug-related toxic reactions according to NCI CTC AE 50 toxicity evaluation criteria hematological toxicity level 4 or above or non hematological toxicity level 3 or above excluding hair loss
Part 2 Expand the enrollment stage to further evaluate the efficacy and safety of AK112 combined with albumin paclitaxel and cisplatin in first-line treatment of advanced ESCC During the expansion phase 30 subjects will be enrolled and a comprehensive discussion will be conducted based on the safety and efficacy data from the safety introduction phase to determine the dosage
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