RecruitingPhase 2NCT06430658

Neoadjuvant Comprehensive Treatment for Unresectable Esophageal Cancer

NEoadjuvant Total RX for Borderline Unresectable Esophageal Squamous Cell Carcinoma: a Prospective Randomized, Three-Arm, Open-Label Phase II Trial (NEXUS-2)


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

90 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) that is deemed unresectable face a bleak prognosis. Recent phase 1/2 studies have demonstrated the efficacy and safety of augmenting neoadjuvant concurrent chemoradiotherapy with immunotherapy in treating resectable ESCC. The present study is a prospective, 3-arm, randomized trial that seeks to evaluate the efficacy of diverse conversion therapy modalities in patients with unresectable ESCC. The study objectives include R0 resection rate, treatment-related adverse events, morbidity and mortality, 1-year progression-free survival (PFS), and 1-year overall survival (OS) rates. Tislelizumab is a humanized IgG4 monoclonal antibody with high affinity/specificity for programmed cell death protein 1 (PD-1). Tislelizumab was specifically engineered to minimize binding to FcɤR on macrophages, thereby abrogating antibody-dependent phagocytosis, a potential mechanism of T-cell clearance and resistance to anti-PD-1 therapy. This trial will provide valuable insights into the effectiveness of the three conversion therapy modalities and help to inform clinical decision-making for patients with unresectable locally advanced ESCC.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of treatments — immunotherapy, chemotherapy, radiation, and targeted therapy — given before surgery for people with locally advanced esophageal squamous cell cancer (ESCC) that is borderline resectable (not clearly operable at first). The goal is to shrink the tumor enough to allow curative surgery. **You may be eligible if...** - You have confirmed squamous cell carcinoma of the thoracic (chest) esophagus - Your tumor is locally advanced and borderline resectable — suspected but not confirmed to be stuck to nearby structures or with spread to nearby lymph nodes - You have not received any prior cancer treatment - You are in generally good health (KPS score 70 or higher) - Your blood counts, liver, kidney, and other organ functions are within acceptable ranges **You may NOT be eligible if...** - You have another type of cancer at the same time or have had one previously (with limited exceptions) - You have already received any prior cancer treatment - Your cancer has spread to distant sites such as supraclavicular lymph nodes or other organs (metastatic disease) - Your doctor has determined that the tumor is at risk of bleeding from major blood vessels or esophageal perforation - You have active infections, including active hepatitis B, C, or tuberculosis - You are pregnant or breastfeeding 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

COMBINATION_PRODUCTTislelizumab (BGB-A317) with chemoradiotherapy

Different sequences and methods of treatment to convert surgery


Locations(1)

Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

Beijing, China

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NCT06430658


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