AK104 Plus Concurrent Chemoradiation Therapy in Esophageal Squamous Cell Carcinoma

Phase 2

Not yet recruiting

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Drug: AK104

• Registration Number: NCT05594914
• Lead Sponsor: The First Affiliated Hospital of University of South China

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).

Study Timeline

• Status Verified: 2022-10
• Study Start: 2022-10
• Study First Submitted: 2022-10-15
• Study First Submitted QC: 2022-10-25
• Last Update Submitted: 2022-10-25
• Study First Posted: 2022-10-26
• Last Update Posted: 2022-10-26
• Primary Completion: 2023-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 47

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AK104 plus concurrent chemoradiation therapy	AK104	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.

Primary Outcome Measures

Name	Time	Method
ORR	24 months	objective response rate
DoR	24 months	duration of overall response
AE	24 months	adverse event
DCR	24 months	disease control rate
TTR	24 months	time to resolve

Secondary Outcome Measures

Name	Time	Method
PFS	24 months	progression-free survival
OS	24 months	overall survival