NCT06084897 Radiotherapy in Patients With Metastatic Esophageal Cancer Responding to PD-1 Inhibitor Plus Chemotherapy
| NCT ID | NCT06084897 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Esophageal Neoplasm Metastatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-10-16 |
| Primary Completion | 2026-04-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2023-10-16 with a primary completion date of 2026-04-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The treatment efficacy for stage IVb esophageal cancer has been improved through chemotherapy combined with immunotherapy recently. On this basis, the investigators intend to conduct a prospective, multicenter phase II clinical trial to assess whether radiotherapy could further improve the survival of patients with metastatic esophageal cancer responding to PD-1 Inhibitor plus chemotherapy. Accompanied tissue samples, blood samples and urine samples will be analyzed by molecular biological detection (Including Whole Exome Sequencing and proteomics) to explore potential biomarkers for predicting outcomes, efficacy and toxicity.
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 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.
Contact & Investigator
Wen-Yang Liu, MD
PRINCIPAL INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Frequently Asked Questions
Who can join the NCT06084897 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Neoplasm Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06084897 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06084897 currently recruiting?
Yes, NCT06084897 is actively recruiting participants. Contact the research team at liuwenyang@cicams.ac.cn for enrollment information.
Where is the NCT06084897 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06084897 clinical trial?
NCT06084897 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The principal investigator is Wen-Yang Liu, MD at Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 120 participants.