AK104 Plus Concurrent Chemoradiation Therapy in Esophageal Squamous Cell Carcinoma

October 25, 2022 updated by: The First Affiliated Hospital of University of South China

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

47

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 24 months
progression-free survival
24 months
OS
Time Frame: 24 months
overall survival
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of University of South China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

October 15, 2022

First Submitted That Met QC Criteria

October 25, 2022

First Posted (Actual)

October 26, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022KS-FL-13-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Esophageal Squamous Cell Carcinoma

Clinical Trials on AK104

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe