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NCT05594914 Clinical Trial

AK104 Plus Concurrent Chemoradiation Therapy in Esophageal Squamous Cell Carcinoma

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:
The Preliminary Efficacy and Safety of AK104 Plus Concurrent Chemoradiation Therapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05594914
Other study ID # 2022KS-FL-13-02
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date October 2022
Est. completion date December 2025

Study information
Verified date October 2022
Source The First Affiliated Hospital of University of South China
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 47
Est. completion date December 2025
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
The First Affiliated Hospital of University of South China

Outcome
Type Measure Description Time frame Safety issue
Primary ORR objective response rate 24 months
Primary DCR disease control rate 24 months
Primary DoR duration of overall response 24 months
Primary TTR time to resolve 24 months
Primary AE adverse event 24 months
Secondary PFS progression-free survival 24 months
Secondary OS overall survival 24 months
See also
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