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

NCT06464614 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-06-18

No results posted yet for this study

Summary

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).

Conditions

  • Esophageal Cancer

Interventions

DRUG

Adebrelimab

Adebrelimab 1200mg，d1，q3w, until disease progression or unacceptable toxicity

DRUG

Apatinib

Apatinib 250mg，d1-21，q3w, until disease progression or unacceptable toxicity

DRUG

Investigator chosen chemotherapy (ICC)

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.

RADIATION

Radiotherapy

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Henan University of Science and Technology

    lead OTHER

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
2024-07-15
Primary Completion
2025-08-01
Completion
2026-08-01

Countries

  • China

Study Locations

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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 NCT06464614 on ClinicalTrials.gov