Radiotherapy followed by immunotherapy for advanced esophageal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Kuaile Zhao, MD
• Email: kuaile_z@sina.com
• Phone: +86-21-64175590

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining immunotherapy with targeted radiotherapy and chemotherapy for advanced esophageal cancer

  This study is testing if adding immunotherapy to a combination of targeted radiotherapy and chemotherapy can help people with advanced esophageal cancer feel better and improve their treatment results.

  Recruiting Phase 3 Fudan University · Shanghai, Shanghai Municipality · NCT06676449

• Short-Course Radiotherapy Followed by CAPOX With or Without Iparomlimab and Tuvonralimab in Localized Rectal Cancer

  In people with locally advanced, treatment-naive rectal cancer, this study tests whether adding two immunotherapy drugs to a standard chemotherapy after short-course radiotherapy can improve tumor response.

  Recruiting Phase 3 Shandong Cancer Hospital and Institute · Jinan, Shandong · NCT07686640

• Prospective cohort of SCLC patients receiving radiotherapy-based comprehensive treatment

  This project will collect detailed clinical, imaging, pathology, and molecular data from adults with limited-stage SCLC who receive radiotherapy with or without chemotherapy and immunotherapy to try to identify which radiotherapy timing, dose, and combinations work best.

  Recruiting Shanghai Chest Hospital · Shanghai, Shanghai Municipality · NCT07565532

• β-hydroxybutyrate with short-course radiotherapy, immunotherapy and CAPEOX before surgery for locally advanced rectal cancer

  This phase II trial will test whether adding β-hydroxybutyrate supplements to short-course radiotherapy followed by immunotherapy plus CAPEOX chemotherapy improves outcomes for people with locally advanced rectal cancer before surgery.

  Recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07239466

• Neoadjuvant radiotherapy plus SOX chemotherapy with Iparomlimab and Tuvonralimab for resectable gastric and gastroesophageal junction adenocarcinoma

  This trial will test whether adding radiotherapy to pre-surgery SOX chemotherapy plus two immunotherapy drugs (Iparomlimab and Tuvonralimab) helps people with resectable, HER2‑negative gastric or gastroesophageal junction cancer.

  Recruiting Phase 2 Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Chongqing, Other (Non U.s.) · NCT07165847

• Long-course versus short-course radiotherapy before immunotherapy and total neoadjuvant therapy for locally advanced rectal cancer

  This trial tests whether adding immunotherapy to total neoadjuvant therapy and using short-course versus long-course radiotherapy improves outcomes for adults with locally advanced rectal cancer.

  Recruiting Phase 3 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07113275

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.