Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, 100021, China
Location status: Recruiting
NCT Number: NCT06430658
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
Beijing, 100021, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Different sequences and methods of treatment to convert surgery
Time frame: 4 months
Minimal distance tumor/circumferential resection margin (CRM) > 1 mm.
Time frame: 1 year after all treatment
Defined as the proportion of patients still alive within one year from treatment initiation.
Time frame: 1 year after all treatment
Defined as the proportion of patients without disease progression or death within one year from treatment initiation.
Time frame: 6 month
To investigate whether ctDNA variation can be used for MRD predicting incidence of pathological incidence and monitoring tumor progression after surgery
Time frame: 4 month
Adverse event during chemoRT or immunotherapy
Time frame: 4 month
Time frame: 4 month
Contact information is provided by the study sponsor or research team.
Xin Wang, Doctor
CONTACT
Ziyu Zheng, B.M
CONTACT
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Other
NEoadjuvant Total RX for Borderline Unresectable Esophageal Squamous Cell Carcinoma: a Prospective Randomized, Three-Arm, Open-Label Phase II Trial (NEXUS-2)
Acronym: NEXUS-2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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