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NCT06084897RecruitingPhase 2

Radiotherapy in Patients With Metastatic Esophageal Cancer Responding to PD-1 Inhibitor Plus Chemotherapy

Radiotherapy in Patients With Metastatic Esophageal Cancer Responding to PD-1 Inhibitor Plus Chemotherapy: a Patient Preference Multicenter Randomized Phase II Trial

Source: ClinicalTrials.gov · Last updated 14 Jun 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 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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
120 (estimated)
First submitted
19 Sept 2023
Start date
16 Oct 2023
Primary completion date
26 Apr 2026
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
NCT number
NCT06084897

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 120
  • From 16 Oct 2023 to the primary completion date, 26 Apr 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 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cancer hospital, CAMS
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.