Study of Anti-PD-L1 in Combination With Chemo(Radio)Therapy for Resectable Esophageal Squamous Cell Carcinoma

Sponsor
Peking Union Medical College Hospital
Study ID
NCT04568200
Phase
PHASE2
Status
Completed

Conditions

  • Esophageal Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Durvalumab 1500mg i.v. day 1-22-43-64
  • Carboplatin — DRUG
    Chemotherapy
  • Paclitaxel — DRUG
    Chemotherapy
  • Radiotherapy 23 x 1.8 Gy — RADIATION
    Radiotherapy 23 x 1.8 Gy

Study Details

This is a study to evaluate the efficacy and safety of preoperative treatment with durvalumab combined with neoajuvant therapy (carboplatin, paclitaxel with/without radiation) in locally advanced resectable oesophageal squamous carcinoma.

Key Dates

Start date
Jun 19, 2020
Status verified
Jan 2024
Primary completion
Dec 1, 2023
Completion
Jan 1, 2024

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: durvalumab and neoadjuvant therapy
    durvalumab 1500mg i.v. day 1-22-43-64 Carboplatin AUC = 4-5 i.v day 1-22-43-64 Paclitaxel 75 mg/m2 i.v day 1-22-43-64 with/without Radiotherapy 23 x 1.8 Gy
  • Placebo Comparator: normal saline and neoadjuvant therapy
    normal saline 500ml i.v. day 1-22-43-64 Carboplatin AUC = 4-5 i.v day 1-22-43-64 Paclitaxel 75 mg/m2 i.v day 1-22-43-64 with/without Radiotherapy 23 x 1.8 Gy

Primary Outcome Measure

tumor response [ Time Frame: up to 12 months ]

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