Combining PD-1 inhibitors with chemotherapy and radiotherapy for metastatic 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 phase III clinical trial aims to evaluate the effectiveness of combining PD-1 inhibitors with chemotherapy and radiotherapy in patients with stage IVb metastatic esophageal cancer. The study will involve a multicenter approach, where participants will receive either chemotherapy alone or in combination with radiotherapy and immunotherapy. Researchers will analyze tissue, blood, and urine samples to identify potential biomarkers that could predict treatment outcomes and side effects. The goal is to determine if this combination therapy can improve survival rates and quality of life for patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. ≥18 years, any gender
* 2\. Histologically or cytologically confirmed squamous cell carcinoma of esophageal cancer. The initial clinical stage is IVb (2018 American Joint Committee on Cancer (AJCC) Cancer Staging Manual, 8th Edition) , with distant metastasis involving no more than 2 organs (lymph node metastasis is counted);
* 3\. ECOG (Eastern Cooperative Oncology Groupper) formance status \<= 1. Patients aged 65 years and over need to complete G8 screening or Comprehensive Geriatric Assessment, and the final evaluation is good;
* 4.There was no significant abnormality in laboratory routine indicators such as blood routine and liver and kidney function;
* 5.No prior history of thoracic radiation;
* 6.Expected survival is more than 12 weeks;
* 7.Informed consent provided.

Exclusion Criteria:

* 1.Patients with other cancer history except hypopharyngeal carcinoma in situ, non-malignant skin cancer and cervical carcinoma in situ.
* 2.Received surgery (except ostomy), chemotherapy or other anti-tumor treatment before enrollment；
* 3\. Active infection currently exists . The following conditions occurred within 6 months before randomization: myocardial infarction, cerebrovascular accident, or received gastrointestinal, neurological, cardiopulmonary surgery;
* 4\. History of allergy to chemotherapy drugs or autoimmune disease;
* 5\. Participate in other clinical trials at present or within 4 weeks before enrollment;
* 6.There are factors such as high risk of fistula that radiotherapy cannot be safely carried out as assessed by the radiation oncologist.

Where it's running

• Cancer hospital, CAMS
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Lin Shen, MD — Peking University Cancer Hospital & Institute
• Study coordinator: Wen-Yang Liu, MD
• Email: liuwenyang@cicams.ac.cn
• Phone: 8601087787625

Similar studies

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

• Proximal versus total gastrectomy for locally advanced Siewert type II–III gastroesophageal junction cancer

  This will see if keeping part of the stomach (proximal gastrectomy) or removing the whole stomach (total gastrectomy) leads to better 3-year disease-free survival for adults with locally advanced Siewert type II–III gastroesophageal junction cancer.

  Recruiting Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Istanbul, Istanbul · NCT07482566

• Omega-3 supplements with PD-1 therapy for advanced esophageal cancer

  This trial will test whether taking omega-3 fish oil (EPA+DHA) together with PD-1 immunotherapy helps adults with recurrent or metastatic esophageal cancer maintain muscle and have better clinical and patient-reported outcomes than a placebo.

  Recruiting Fudan University · Shanghai, Shanghai Municipality · NCT07272382

• LY4337713 for people with FAP-positive ovarian, breast, pancreatic, colorectal, or esophageal cancers

  This trial tests LY4337713, a FAP-targeted lutetium-177 therapy, in people with advanced cancers that show high levels of fibroblast activation protein (FAP).

  Recruiting at 17 sites Phase 1 Eli Lilly and Company · Newport Beach, California and 29 other locations · NCT07213791

• LY4257496 for GRPR-positive advanced breast, colorectal, prostate, and endometrial cancer (OMNIRAY)

  This Phase 1 test tries LY4257496, with GRPR imaging using LY4257529 and sometimes standard treatments, to see if it is safe and helps people with GRPR-positive advanced breast, colorectal, prostate, or endometrial cancer.

  Recruiting at 15 sites Phase 1 Eli Lilly and Company · Duarte, California and 32 other locations · NCT07114601

• High-sensitivity blood test to detect and monitor multiple cancers

  This study will test a high-sensitivity blood test that looks for tumor DNA to detect and follow several common cancers in adults with those cancers or people having routine health screenings.

  Recruiting Yonsei University · Seoul · NCT07035587

• Combining Fruquintinib and Tislelizumab with Radiotherapy for Esophageal Cancer

  This study is testing if combining two new cancer treatments, Fruquintinib and Tislelizumab, with radiation can help people with advanced esophageal cancer feel better and improve their outcomes.

  Recruiting Phase 2 Hebei Medical University Fourth Hospital · Shijiazhuang, Hebei · NCT06646588

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.