Optimizing treatment 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 enhance neoadjuvant treatment regimens for patients with locally advanced esophageal squamous cell carcinoma by evaluating the efficacy and safety of a combination of chemotherapy, immunotherapy (Pembrolizumab), and radiotherapy. Building on previous findings that showed a significant pathological complete response rate, the study will explore the optimal number of immunotherapy cycles to maximize patient outcomes. Participants will undergo thorough evaluations to confirm their eligibility based on specific clinical criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* male or female
* Age ≥ 18 years old
* Pathological confirmation of esophageal squamous cell carcinoma
* Endoscopic ultrasound, enhanced CT scan of the neck, chest, and abdomen, and esophageal magnetic resonance imaging evaluate as T3 or resectable T4 PET/CT、 Cervical, thoracic, and abdominal enhanced CT evaluation of N0 or N+
* No clear distant metastasis (M0) and only cervical or supraclavicular lymph node metastasis (M1a)
* Tumor longitudinal diameter ≤ 10cm
* The tumor did not involve the dentate line
* ECOG score 0 or 1
* No hematological diseases, no liver or kidney dysfunction
* Absolute neutrophil count ≥ 1.5 × 109/L
* Platelets ≥ 100 × 109/L
* Hemoglobin ≥ 11g/L
* ALT ≤ 2 times the upper limit of normal value
* TBil ≤ 1.5 times the upper limit of normal value
* Creatinine clearance rate (Cockroft) ≥ 50ml/min
* Obtain informed consent

Exclusion Criteria:

* T staging evaluation is T1/T2
* PET/CT and other evaluations show distant metastasis (M1)
* Planned pregnancy or patients during pregnancy or lactation
* History of previous chemotherapy, radiation therapy, or immunotherapy
* Previous severe coronary heart disease and heart failure (NYHA grade III/IV)
* Previous pulmonary interstitial fibrosis or severe pulmonary dysfunction that cannot tolerate surgery
* Previous autoimmune disease requiring systemic treatment within 2 years
* Previous immunodeficiency diseases or the need for systemic steroid replacement therapy
* Previous motor or sensory neurotoxic diseases
* Previous mental illness
* Potential diseases that may affect patients' ability to receive planned treatment, such as drug allergies
* Acute infectious diseases requiring systemic treatment
* Previous HIV, HBV, or HCV infections
* Previously received stem cell or solid organ transplantation

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Li Li
• Email: Lili4037@pumch.cn
• Phone: +86-10-69152630

Similar studies

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

• Interferon-gamma plus camrelizumab with chemotherapy before surgery for locally advanced esophageal squamous cell carcinoma

  This trial tests whether giving interferon-gamma with camrelizumab and chemotherapy before surgery helps patients with locally advanced esophageal squamous cell carcinoma.

  Recruiting at 2 sites Phase 2 Hefei Cancer Hospital of the Chinese Academy of Sciences · Hefei, Anhui and 1 other locations · NCT07787273

• Tislelizumab plus chemotherapy to convert unresectable locally advanced esophageal squamous cell carcinoma to surgery

  This study will try whether adding the immune drug tislelizumab to chemotherapy can shrink tumors so people with initially unresectable locally advanced esophageal squamous cell carcinoma can become eligible for surgery.

  Recruiting Shandong Provincial Hospital · Jinan, Shandong · NCT07549100

• Combining Toripalimab with Chemoradiotherapy for Esophageal Cancer

  This study is testing if adding a new drug called Toripalimab to standard chemotherapy and radiation can help people with locally advanced esophageal cancer respond better to treatment before surgery.

  Recruiting Phase 2 Nanfang Hospital, Southern Medical University · Guangzhou, Baiyun District · NCT06843889

• Cadonilimab with paclitaxel micelles and cisplatin before surgery for locally advanced esophageal squamous cancer

  This trial will test whether giving cadonilimab together with paclitaxel polymeric micelles and cisplatin before surgery helps people with locally advanced esophageal squamous cell carcinoma.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT06356688

• Immunotherapy with radiotherapy and nutrition support for advanced esophageal cancer in patients who can’t tolerate standard chemoradiation

  This trial tests whether adding a PD-1 inhibitor (sintilimab) to radiotherapy plus specialized nutrition helps patients with locally advanced esophageal squamous cell carcinoma who can’t tolerate standard chemoradiation.

  Recruiting at 10 sites Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality and 9 other locations · NCT06342167

• Using Toripalimab after Chemoradiotherapy for Elderly Esophageal Cancer

  This study is testing if the drug toripalimab can help older patients with advanced esophageal cancer feel better and lower their chances of the cancer coming back after they’ve had chemoradiotherapy.

  Recruiting Phase 2 Sun Yat-sen University · Guangzhou, Guangdong · NCT06187597

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.