NCT06086457RecruitingPhase 3
PD-1 Inhibitor Plus Chemotherapy With or Without Radiotherapy in Patients With Metastatic Esophageal Cancer
PD-1 Inhibitor Plus Chemotherapy With or Without Radiotherapy in Patients With Metastatic Esophageal Cancer: A Randomized Multicenter Phase III Trial
Source: ClinicalTrials.gov · Last updated 16 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 III clinical trial to assess whether radiotherapy with concurrent chemotherapy and immunotherapy could further improve the survival of patients with metastatic esophageal cancer. 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 436 (estimated)
- First submitted
- 21 Sept 2023
- Start date
- 4 Feb 2024
- Primary completion date
- 28 Jun 2026
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06086457
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 436
- From 4 Feb 2024 to the primary completion date, 28 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- 5\. Participate in other clinical trials at present or within 4 weeks before enrollment;
Other illness
- 1.Patients with other cancer history except hypopharyngeal carcinoma in situ, non-malignant skin cancer and cervical carcinoma in situ.
- 4\. History of allergy to chemotherapy drugs or autoimmune disease;
- 6.There are factors such as high risk of fistula that radiotherapy cannot be safely carried out as assessed by the radiation oncologist.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer hospital, CAMS Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.