Combining immunotherapy with chemoradiotherapy 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 investigates the safety and efficacy of a treatment regimen that includes induction immunochemotherapy followed by concurrent chemoradiotherapy using an anti-PD-1 therapy for patients with unresectable locally advanced esophageal cancer. The study aims to determine how well this combination can improve progression-free survival and treatment completion rates. By integrating immunotherapy into the treatment plan, the trial seeks to enhance tumor regression and optimize the effectiveness of subsequent radiotherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age between 18 and 75 years.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
3. Clinical stage meeting the criteria of T1N+M0 or T2-4aN0-3M0 based on the 8th UICC-TNM classification.
4. Ineligibility for surgical resections due to patients' unwillingness for surgery, technically unresectable disease, or being medically unfit for surgery.
5. No prior anti-tumor treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy.
6. Adequate hematological, pulmonary, cardiac, hepatic, renal, and thyroid function.
7. Willingness to use contraception with an adequate method throughout the study.
8. Documented informed consent.

Exclusion Criteria:

1. History of malignant disease within the 5 years preceding enrollment or presence of other malignant tumors or non-squamous cell carcinoma components.
2. High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation as determined by the investigators.
3. Weight loss exceeding 20% within the 90 days prior to the first day of drug administration.
4. Presence of long-standing unhealed wounds or fractures or undergoing major surgical resections within 60 days preceding the first day of drug administration.
5. Presence of any severe or uncontrolled coexisting diseases, including but not limited to:

   * Uncontrolled hypertension
   * History of interstitial lung disease or non-infectious pneumonia
   * Active hepatitis B or C, syphilis, or other active and uncontrolled infections
   * Cardiac insufficiency (NYHA≥2)
   * Renal dysfunction requiring dialysis
   * Active autoimmune disease
   * History of acquired or congenital immunodeficiency diseases
6. Occurrence of serious arterial/venous thrombotic events within 6 months prior to the first day of drug administration.
7. History of psychotropic substance abuse or inability to quit, or patients with psychotic disorders.
8. Allergy to study drugs.
9. Patients deemed unsuitable for participation due to severe comorbidities or other reasons determined by the investigators.

Where it's running

• Shanghai Chest Hospital
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Wen Yu, M.D — Shanghai Chest Hospital
• Study coordinator: Wen Yu, M.D
• Email: yuzhiwen0827@163.com
• Phone: 021-22200000-3203

Similar studies

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

• Radiotherapy target-volume choices in locally advanced esophageal cancer during immunotherapy

  This observational study looks at how doctors outline the radiation area for locally advanced esophageal squamous cell cancer patients treated with radiotherapy and immunotherapy to see which approaches correlate with better outcomes.

  Recruiting Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07858630

• Sacituzumab Govitecan plus Tislelizumab for advanced esophageal cancer

  This phase II study tests whether the cancer-fighting drug sacituzumab tirumotecan (SKB264) combined with tislelizumab can help adults with advanced esophageal squamous cell carcinoma that progressed after initial immunotherapy.

  Recruiting at 2 sites Phase 2 Shanghai Chest Hospital · Shanghai and 1 other locations · NCT07811752

• Neoadjuvant therapy with adebrelimab, famitinib, and chemotherapy for resectable ESCC

  This study tests a combination of adebrelimab, famitinib, and chemotherapy before surgery in people with resectable locally advanced esophageal squamous cell carcinoma to see if it can lead to a complete tumor disappearance at the time of surgery.

  Recruiting Phase 2 First Affiliated Hospital Xi'an Jiaotong University · Xi'an, Shannxi · NCT07796113

• SKB500 combinations for esophageal squamous cell carcinoma

  This study tests SKB500 combined with other drugs to see if it is safe and shows early signs of activity in adults with unresectable or metastatic esophageal squamous cell carcinoma who have limited prior treatment.

  Recruiting at 24 sites Phase 2 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Changchun and 23 other locations · NCT07700667

• Neoadjuvant Cardonilizumab With Chemotherapy Before Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma

  This study tests whether adding cardonilizumab to preoperative chemotherapy (versus chemoradiotherapy) helps patients with locally advanced ESCC have a better chance at complete tumor removal and longer survival.

  Recruiting Phase 2 Tongji Hospital · Wuhan, Hubei · NCT07699185

• Surgery or chemoradiotherapy after neoadjuvant immunochemotherapy for esophageal squamous cell carcinoma

  In people with locally advanced ESCC who respond to neoadjuvant immunochemotherapy, this study tests whether organ preservation with treatment other than surgery can be as effective as radical esophagectomy.

  Recruiting Phase 3 Henan Cancer Hospital · Zhengzhou, Henan · NCT07629817

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.