AK104 Plus Concurrent Chemoradiation Therapy in Esophageal Squamous Cell Carcinoma
Study Details
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
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).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: AK104 plus concurrent chemoradiation therapy 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. |
Drug: AK104
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.
|
Outcome Measures
Primary Outcome Measures
- ORR [24 months]
objective response rate
- DCR [24 months]
disease control rate
- DoR [24 months]
duration of overall response
- TTR [24 months]
time to resolve
- AE [24 months]
adverse event
Secondary Outcome Measures
- PFS [24 months]
progression-free survival
- OS [24 months]
overall survival
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- The First Affiliated Hospital of University of South China
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022KS-FL-13-02