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NOT YET RECRUITING
NCT06464614
PHASE2

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

View on ClinicalTrials.gov

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).

Official title: A Double-arm, Non-randomized Controlled, Open-label Clinical Study of Adebrelimab in Combination With Apatinib and Chemotherapy/Chemoradiotherapy in Immuno-experienced Second-line Esophageal Squamous Cell Carcinoma.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2024-07-15

Completion Date

2026-08-01

Last Updated

2024-06-18

Healthy Volunteers

No

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.

Locations (1)

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China