Radiotherapy followed by immunotherapy for advanced esophageal cancer

Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized Phase III Trial

This study is testing if a new type of radiation therapy followed by an immune-boosting treatment can help adults with advanced esophageal cancer feel better and improve their health.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 452 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT06964568 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of tumor draining lymph nodes-sparing radiotherapy (TDLN-sparing RT) followed by maintenance therapy with a PD-1 inhibitor in treating locally advanced esophageal squamous cell carcinoma (ESCC) in adults. Participants will receive TDLN-sparing RT, which is designed to minimize damage to surrounding lymph nodes, followed by immunotherapy to enhance the body's immune response against cancer. The study will assess the safety and efficacy of this combined approach in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed locally advanced esophageal squamous cell carcinoma.

Not a fit: Patients with esophageal perforation, active autoimmune diseases, or those who do not meet the specified organ function criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and less harmful option for patients with locally advanced esophageal cancer.

How similar studies have performed: Other studies have shown promising results with similar approaches combining radiotherapy and immunotherapy, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Written informed consent
2. Aged 18 years or above
3. Histologically confirmed esophageal squamous cell carcinoma
4. Clinical stages T3-4N0M0 or TxN+M0 or TxNxM1 (Only for supraclavicular lymph nodes) based on the 8th UICC-TNM classification

7\. Eastern Cooperative Oncology Group(ECOG) performance status: 0-1 8. Life expectancy ≥3 months 9. Adequate organ functions Absolute neutrophil counts (ANC) ≥1.5×109⁄L; Hemoglobin (Hb) ≥9g⁄dl; Platelet (Plt) ≥100×109⁄L; Total bilirubin ≤1.5 upper limit of normal (ULN); Aspartate transaminase (AST) ≤2.5 ULN; Alanine aminotransferase (ALT) ≤2.5 ULN; Creatinine ≤1.5 ULN

Exclusion Criteria:

1. Esophageal perforation or hematemesis
2. Any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism and hypothyroidism (effective hormone replacement therapy excepted)) and immunosuppressive agents or systemic hormonal therapy indicated within 28 days (for adverse events of chemoradiotherapy excepted).
3. Previously received or receiving PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1.
4. Allergic to any of the ingredients in PD-1 inhibitors for injection.
5. Uncontrolled heart diseases or clinical symptoms, such as: (1) New York Heart Association(NYHA) class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4)clinically significant arrhythmia requiring clinical intervention.
6. Congenital or acquired immunodeficiency (such as HIV infection); active hepatitis B (HBV-DNA≥104 copy number/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method); active tuberculosis.
7. Active infection or unexplained fever \>38.5 °C within 2 weeks before randomization (fever due to tumor excepted, according to investigator).

   Patients with fertility reluctant to take contraceptive measures during the trial, or female patients pregnant or breastfeeding.
8. According to the investigator, other factors that may cause termination of the study. ie, other serious diseases (including mental illness) require combined treatment, family or social factors, which may affect the safety or the collection of trial data.

Where this trial is running

Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Kuaile Zhao, MD

Conditions Esophageal Carcinoma; Radiotherapy; Immunotherapy