AK104 Plus Concurrent Chemoradiation Therapy in Esophageal Squamous Cell Carcinoma

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05594914

Enrollment

Registered

2022-10-26

Start date

2022-10-31

Completion date

2025-12-31

Last updated

2022-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Squamous Cell Carcinoma

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).

Interventions

DRUGAK104

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
OS	24 months	overall survival
PFS	24 months	progression-free survival

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026