Radiotherapy for patients with metastatic esophageal cancer responding to immunotherapy and chemotherapy

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 adding radiotherapy to the treatment regimen of patients with stage IVb esophageal cancer who have shown a positive response to a combination of PD-1 inhibitors and chemotherapy. It is a multicenter phase II trial that will analyze tissue, blood, and urine samples to identify potential biomarkers that could predict treatment outcomes and side effects. The study seeks to determine if locoregional radiotherapy can enhance survival rates and improve local control of the disease in these 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 AJCC Cancer Staging Manual, 8th Edition) or recurrent patients with recurrence after radical treatment (radical treatment includes surgery and radiotherapy, but the recurrence site cannot be located in the previous radiotherapy field).
* 3\. ECOG performance 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.For patients after definitive or preoperative radiotherapy, no recurrence was in the prior radiation filed;
* 6.Expected survival is more than 12 weeks;
* 7.Informed consent provided;
* 8.With response to 2-4 cycles of the first-line chemotherapy combined with immunotherapy.

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: Wen-Yang Liu, MD — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• 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.

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• Using radiofrequency ablation to prevent recurrence of esophageal cancer after surgery

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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.