Back to resultsAK104 Plus Concurrent Chemoradiation Therapy in Esophageal Squamous Cell Carcinoma
Primary Purpose
Esophageal Squamous Cell Carcinoma
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AK104
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- unresectable locally advanced esophageal squamous cell carcinoma; ECOG PS 0-1; At least one measurable lesion according to RESIST standard 1.1； not received anti-tumor treatment in the past
Exclusion Criteria:
- received immunotherapy in the past； Active hepatitis B, hepatitis C and other infectious diseases； Severe liver and kidney function, cardiovascular and cerebrovascular abnormalities
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AK104 plus concurrent chemoradiation therapy
Arm Description
AK104 10mg/kg plus TC regimen(paclitaxel liposome 135mg/m2, carboplatin AUC=5), once every 3 weeks (Q3W), induction treatment for 2 cycles; Subsequently, AK104 10 mg/kg plus TC regimen(paclitaxel liposome 135mg/m2, carboplatin AUC=5) is combined with radiotherapy(50Gy/25F) for 2 cycles.
Outcomes
Primary Outcome Measures
ORR
objective response rate
DCR
disease control rate
DoR
duration of overall response
TTR
time to resolve
AE
adverse event
Secondary Outcome Measures
PFS
progression-free survival
OS
overall survival
Full Information
NCT ID
NCT05594914
First Posted
October 15, 2022
Last Updated
October 25, 2022
Sponsor
The First Affiliated Hospital of University of South China
1. Study Identification
Unique Protocol Identification Number
NCT05594914
Brief Title
AK104 Plus Concurrent Chemoradiation Therapy in Esophageal Squamous Cell Carcinoma
Official Title
The Preliminary Efficacy and Safety of AK104 Plus Concurrent Chemoradiation Therapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of University of South China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to assess the safety and efficacy of AK104 plus concurrent chemoradiation therapy in unresectable locally advanced esophageal squamous cell carcinoma
Detailed Description
AK104 10mg/kg plus TC regimen(paclitaxel liposome 135mg/m2, carboplatin AUC=5), once every 3 weeks (Q3W), induction treatment for 2 cycles; Subsequently, AK104 10 mg/kg plus TC regimen(paclitaxel liposome 135mg/m2, carboplatin AUC=5) is combined with radiotherapy(50Gy/25F) for 2 cycles. Assess disease efficiency( objective response rate; disease control rate; duration of overall response; time to resolve) and safety( adverse event).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AK104 plus concurrent chemoradiation therapy
Arm Type
Experimental
Arm Description
AK104 10mg/kg plus TC regimen(paclitaxel liposome 135mg/m2, carboplatin AUC=5), once every 3 weeks (Q3W), induction treatment for 2 cycles; Subsequently, AK104 10 mg/kg plus TC regimen(paclitaxel liposome 135mg/m2, carboplatin AUC=5) is combined with radiotherapy(50Gy/25F) for 2 cycles.
Intervention Type
Drug
Intervention Name(s)
AK104
Intervention Description
AK104 plus TC regimen(paclitaxel liposome , carboplatin), once every 3 weeks (Q3W), induction treatment for 2 cycles; Subsequently, AK104 plus TC regimen is combined with radiotherapy for 2 cycles.
Primary Outcome Measure Information:
Title
ORR
Description
objective response rate
Time Frame
24 months
Title
DCR
Description
disease control rate
Time Frame
24 months
Title
DoR
Description
duration of overall response
Time Frame
24 months
Title
TTR
Description
time to resolve
Time Frame
24 months
Title
AE
Description
adverse event
Time Frame
24 months
Secondary Outcome Measure Information:
Title
PFS
Description
progression-free survival
Time Frame
24 months
Title
OS
Description
overall survival
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
unresectable locally advanced esophageal squamous cell carcinoma; ECOG PS 0-1; At least one measurable lesion according to RESIST standard 1.1； not received anti-tumor treatment in the past
Exclusion Criteria:
received immunotherapy in the past； Active hepatitis B, hepatitis C and other infectious diseases； Severe liver and kidney function, cardiovascular and cerebrovascular abnormalities
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
AK104 Plus Concurrent Chemoradiation Therapy in Esophageal Squamous Cell Carcinoma
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