Combination Immunotherapy of Adebrelimab With Apatinib and Tegafur, Gimeracil and Oteracil Potassium Capsules for Immune Rechallenge Therapy in Esophageal Squamous Cell Carcinoma

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study ID
NCT06339619
Phase
PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Adebrelimab — DRUG
    20mg/kg ivgtt D1 Q3W
  • Apatinib — DRUG
    250mg PO QD
  • Tegafur — DRUG
    dosing based on body surface area：BSA\<1.25m2,40mg; BSA=1.25～1.5m2,50mg; BSA\>1.5m2, 60mg，PO QD D1-21 Q3W

Study Details

The goal of this single-arm study is to explore the efficacy and safety of Adebrelimab in combination with Apatinib and Tegafur for the treatment of locally advanced or metastatic esophageal squamous cell carcinoma that has failed first-line standard treatment with PD-1 inhibitors in combination with chemotherapy.

Key Dates

Start date
Mar 11, 2024
Status verified
May 2026
Primary completion
Mar 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adebrelimab+Apatinib+Tegafur

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: 6 months ]

Central Contacts