RecruitingPhase 2NCT06869213

A Single-arm, Open, Single-center Exploratory Study of Adebrelimab (SHR-1316) in Combination With Chemotherapy for the Perioperative Treatment of Locally Advanced Resectable Esophageal Squamous Carcinoma


Sponsor

Peking University Cancer Hospital & Institute

Enrollment

30 participants

Start Date

Mar 31, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective, observational clinical study. In this study, 30 patients with resectable locally advanced esophageal squamous carcinoma will be prospectively enrolled and treated with adebrelimab (SHR-1316) combined with nab-paclitaxel and cisplatin preoperatively and adebrelimab (SHR-1316) single-agent adjuvant therapy postoperatively, to observe the efficacy and safety of this treatment modality, and to provide clinical evidence for the use of PD-L1 monoclonal antibody in perioperative treatment of esophageal cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug (adebrelimab) to chemotherapy before and after surgery improves outcomes for people with locally advanced esophageal squamous cell cancer — a cancer of the food pipe that has not yet spread to distant organs. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with squamous cell cancer of the esophagus that is locally advanced but can still be removed by surgery - You have not previously received any cancer treatment (chemotherapy, radiation, immunotherapy, or surgery) for your esophageal cancer - You are in good general health (ECOG performance status 0 or 1) - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - Your esophageal cancer has spread to distant organs (metastatic) - You have already received cancer treatment for this diagnosis - You have significant heart, lung, or organ problems that would make surgery unsafe - You have active autoimmune disease or are on immunosuppressive medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdebrelimab (SHR-1316) + Nab-paclitaxel + Cisplatin

All subjects were given 3 cycles of neoadjuvant therapy with adebrelimab (1200 mg D1, IV, Q3W)+Nab-paclitaxel(250 mg/m2 D1,IV,Q3W)+Cisplatin(75 mg/m2 D1,IV,Q3W) preoperatively. Within 4-8 weeks of completion of neoadjuvant therapy, all subjects who were suitable for surgery underwent radical surgery, and patients who underwent radical esophageal cancer with R0 resection were given adebrelimab monotherapy postoperatively until disease recurrence or metastasis, toxicity intolerance, initiation of a new antitumor therapy, subject-initiated request to withdraw from the study, and subject's judgement that the subject needed to be withdrawn from the study. The maximum duration of adebrelimab in the adjuvant phase is 16 cycles.


Locations(1)

Peking University Cancer Hospital

Beijing, China

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NCT06869213


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