Combining PD-1 inhibitors with chemotherapy and radiotherapy for metastatic esophageal cancer

PD-1 Inhibitor Plus Chemotherapy With or Without Radiotherapy in Patients With Metastatic Esophageal Cancer: A Randomized Multicenter Phase III Trial

This study is testing if adding PD-1 inhibitors to chemotherapy and radiotherapy can help people with advanced esophageal cancer live longer and feel better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 436 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: chemotherapy, radiation, immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06086457 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed squamous cell carcinoma of esophageal cancer at stage IVb with limited distant metastasis.

Not a fit: Patients with other active cancers or significant prior thoracic radiation history may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could significantly enhance survival and quality of life for patients with metastatic esophageal cancer.

How similar studies have performed: Previous studies have shown promising results with similar combinations of immunotherapy and chemotherapy, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• 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

Conditions Esophageal Neoplasms; Radiotherapy; PD-1 inhibitor