AK104 Plus Concurrent Chemoradiation Therapy in Esophageal Squamous Cell Carcinoma

The First Affiliated Hospital of University of South China

Status and phase: Not yet enrolling; Phase 2

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Drug: AK104

Study type: Interventional

Funder types: Other

Identifiers

NCT05594914

2022KS-FL-13-02

Details and patient eligibility

About

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

Full 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).

Enrollment: 47 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

AK104 plus concurrent chemoradiation therapy

Experimental group

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.

Treatment:

Drug: AK104