Adebrelimab in Combination With Apatinib and Chemotherapy/Chemoradiotherapy in Immuno-experienced Second-line ESCC.

Sponsor
The First Affiliated Hospital of Henan University of Science and Technology
Study ID
NCT06464614
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Adebrelimab — DRUG
    Adebrelimab 1200mg，d1，q3w, until disease progression or unacceptable toxicity
  • Apatinib — DRUG
    Apatinib 250mg，d1-21，q3w, until disease progression or unacceptable toxicity
  • Investigator chosen chemotherapy (ICC) — DRUG
    Nab-paclitaxel: 125mg/m2 intravenously, D1, D8, q3w, 4-6 cycles;Intravenous infusion of 100 mg, D1, qw is used at the same time as radiotherapy. Ilinotecan: 125mg/m2 intravenously, D1, D8, q3w, 4-6 cycles; Capecitabine, 625 mg/m2 orally, d1-14, q3w; continued until disease progression, intolerable toxicity, or withdrawal due to other reasons; when synchronized with radiotherapy, 625mg/m2, bid, oral, d1-5, qw.
  • Radiotherapy — RADIATION
    Radiotherapy mode: IMRT for the primary lesion and SBRT for the metastasis; If the patient has symptoms of dysphagia, the radiation dose is 1.8 Gy×28 F or 2 Gy×25 F, d1-5 5 times a week; If oligometastatic lesions occur in the body: the radiation dose is 8 Gy×5F, d1-5; If oligometastatic lesions occur in the brain, the radiation dose is 7 Gy×5F, d1-5.

Study Details

To assess the efficacy and safety of adebrelimab in combination with apatinib mesylate and chemoradiotherapy in immuno-experienced second-line esophageal squamous cell carcinoma (with symptomatic dysphagia or oligometastatic disease)，and to evaluate the efficacy and safety of adebrelimab in combination with apatinib mesylate and chemoradiotherapy in immuno-experienced second-line esophageal squamous cell carcinoma (without symptomatic dysphagia or oligometastatic disease).

Key Dates

First listed
Jun 18, 2024
Start date
Jul 15, 2024
Status verified
Jun 2024
Primary completion
Aug 1, 2025
Completion
Aug 1, 2026

Study Design

Enrollment
54 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Adebrelimab＋Apatinib＋Radiotherapy＋Investigator chosen chemotherapy (ICC)
    Adebrelimab（1200mg，d1 q3w, continuous medication until disease progression, intolerable toxicity, or withdrawal due to other reasons），Apatinib (250mg，d1-21，q3w), Radiotherapy， Investigator chosen chemotherapy (ICC)
  • Experimental: Adebrelimab＋Apatinib＋Investigator chosen chemotherapy (ICC)
    Adebrelimab（1200mg，d1 q3w, continuous medication until disease progression, intolerable toxicity, or withdrawal due to other reasons），Apatinib (250mg，d1-21，q3w), Investigator chosen chemotherapy (ICC)

Primary Outcome Measure

Progression-free survival，PFS [ Time Frame: 9 months ]

Central Contacts

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