Radiotherapy for patients with metastatic esophageal cancer responding to immunotherapy and chemotherapy
Radiotherapy in Patients With Metastatic Esophageal Cancer Responding to PD-1 Inhibitor Plus Chemotherapy: a Patient Preference Multicenter Randomized Phase II Trial
This study is testing if adding radiation treatment can help people with advanced esophageal cancer who are responding well to immunotherapy and chemotherapy live longer and better manage their disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06084897 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed stage IVb esophageal squamous cell carcinoma who have responded to initial chemotherapy and immunotherapy.
Not a fit: Patients with esophageal cancer not responding to prior chemotherapy and immunotherapy or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with metastatic esophageal cancer.
How similar studies have performed: Previous studies have indicated that combining locoregional radiotherapy with systemic therapy can improve outcomes in similar patient populations, suggesting a promising avenue for further investigation.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.