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Trial Title:
AK104 Plus Concurrent Chemoradiation Therapy in Esophageal Squamous Cell Carcinoma
NCT ID:
NCT05594914
Condition:
Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AK104
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.
Arm group label:
AK104 plus concurrent chemoradiation therapy
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).
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
October 2022
Completion date:
December 2025
Lead sponsor:
Agency:
The First Affiliated Hospital of University of South China
Agency class:
Other
Source:
The First Affiliated Hospital of University of South China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05594914
