AK104 Plus Concurrent Chemoradiation Therapy in Esophageal Squamous Cell Carcinoma

Sponsor
The First Affiliated Hospital of University of South China (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05594914
Collaborator
(none)
47
1
38

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
47 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Preliminary Efficacy and Safety of AK104 Plus Concurrent Chemoradiation Therapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. ORR [24 months]

    objective response rate

  2. DCR [24 months]

    disease control rate

  3. DoR [24 months]

    duration of overall response

  4. TTR [24 months]

    time to resolve

  5. AE [24 months]

    adverse event

Secondary Outcome Measures

  1. PFS [24 months]

    progression-free survival

  2. OS [24 months]

    overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The First Affiliated Hospital of University of South China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The First Affiliated Hospital of University of South China
ClinicalTrials.gov Identifier:
NCT05594914
Other Study ID Numbers:
  • 2022KS-FL-13-02
First Posted:
Oct 26, 2022
Last Update Posted:
Oct 26, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2022