Treatment for patients with 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)

This study is testing if a new combination of a medication called Tislelizumab with chemotherapy and radiation can help people with advanced esophageal cancer that can't be surgically removed live longer and feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, Tislelizumab
• Locations: 1 site (Beijing)
• Trial ID: NCT06430658 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a combination of Tislelizumab, a monoclonal antibody, with chemoradiotherapy in patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) that is considered unresectable. It is a prospective, 3-arm, randomized trial aimed at assessing various conversion therapy modalities. Key objectives include measuring the R0 resection rate, treatment-related adverse events, morbidity and mortality, as well as 1-year progression-free survival and overall survival rates.

Who should consider this trial

Good fit: Ideal candidates are patients with histologically confirmed locally advanced esophageal squamous cell carcinoma who have not received prior anti-cancer treatments.

Not a fit: Patients with synchronous or metachronous primary malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with unresectable esophageal cancer.

How similar studies have performed: Previous studies have shown promising results with similar approaches combining immunotherapy and chemoradiotherapy in treating resectable esophageal cancer.

Eligibility criteria

Inclusion Criteria:

1. Histologically confirmed sorely ESCC without other histology subtypes.
2. Thoracic esophageal cancer.
3. No prior anti-cancer treatment, including but not limited to surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
4. Borderline unresectable locally advanced ESCC deemed by investigators as suspicious of but not confirmed T4b according to the American Joint Committee on Cancer (AJCC) 8th edition staging classification or extracapsular lymph node involvement (ELNI).
5. The Karnofsky Performance Scale (KPS) ≥70.
6. Normal primary organ functions, including but not limited to hemoglobin (Hb) ≥ 100g/L; white blood cell (WBC) ≥ 3.5×10\*9/L; neutrophil count (NEUT) ≥ 1.5×10\*9/L; platelets (PLT) ≥ 100×10\*9/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5×UNL; total bilirubin (TBIL) ≤ 1.5×UNL; creatinine ≤ 1.5UNL; blood urea nitrogen (BUN) ≤ 1.0×UNL.

Exclusion Criteria:

1. Synchronous and metachronous primary malignancies in but not limited to the upper aerodigestive tract, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
2. Patients have undergone any type of anti-cancer treatment.
3. Baseline clinical stage M1 per AJCC 8th edition of staging classification, including supraclavicular lymph node metastases.
4. Investigators assessed major vessel involvement with high-risk hemorrhage.
5. A higher probability of esophageal perforation during conversion therapy.
6. Active infectious diseases, including but not limited to tuberculosis, hepatitis B virus, or hepatitis C virus.
7. Allergic to anti-cancer agents, including but not limited to anti-PD-1 or chemotherapy agents.
8. Given cardiopulmonary dysfunction, patients can not tolerate conversion therapy or surgery.
9. Pregnant or lactating women and women of childbearing potential who lacked effective contraception.
10. Non-compliance with the inclusion criteria judged by investigators.

Where this trial is running

Beijing

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

Study contacts

• Study coordinator: Xin Wang, Doctor

Conditions Esophagus Cancer; Chemoradiotherapy; conversion surgery; immunotherapy