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AK104 Alone or in Combination With Chemotherapy in the First-line Treatment of ESCC

NCT05522894 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-08-31

No results posted yet for this study

Summary

This is a two-arm, open, multicenter clinical study to evaluate the efficacy and safety of AK104 alone or in combination with cisplatin and paclitaxel in the treatment of advanced esophageal squamous carcinoma without systemic therapy.

Conditions

  • Unresectable Esophageal Squamous Cell Carcinoma
  • Locally Advanced Esophageal Squamous Cell Carcinoma
  • Metastatic Esophageal Squamous Cell Carcinoma

Interventions

DRUG

AK104

10mg/kg IV every 3 weeks (Q3W)

DRUG

Cisplatin

75mg/m2 IV every 3 weeks (Q3W)

DRUG

Paclitaxel

175mg/m2 IV every 3 weeks (Q3W)

Sponsors & Collaborators

  • Akeso Pharmaceuticals, Inc.

    collaborator OTHER

  • Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Jing Huang, M.D. · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2024-04-01
Completion
2024-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05522894 on ClinicalTrials.gov