Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT07071103
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years, ≤80 years, regardless of gender.
* ECOG level 0-2.
* Expected life span\>3 months.
* At least one accessible and measurable lesion should be selected as the target lesion for observation according to RECIST criteria.
* Patients with metastatic solid tumors (of any histology) without standard therapy options, who have previously received immunotherapy, immunotherapy combined with chemotherapy, or immunotherapy combined with anti-angiogenesis treatment and have shown disease progression.
* Patients should not be considered eligible for surgical treatment.
* Patients with brain metastases that are assessed as clinically stable after treatment through repeated CT and/or MRI scans are eligible.
* Patients have complete clinical and pathological information.
* Patients should not be borthered by any psychological, family, social or geographical conditions that may hinder compliance with the research protocol.
* Patients should be able to understand the informed consent form, voluntarily participate, and sign the informed consent form.
* Other indicators accord with the general inclusion criteria for clinical trials.
Exclusion Criteria:
* Patients with contraindications to radiation therapy and immunotherapy.
* Previous occurrence of unacceptable immune related toxic side effects (immune myocarditis, pneumonia, etc.).
* Patients who were assessed as hyperprogressive disease (HPD).
* Patients who have received pelvic and abdominal radiation therapy within 6 months prior to enrollment.
* The adverse reactions from prior treatment have not yet recovered to a CTCAE5.0 rating of ≤ 1 (excluding toxicity that has been determined to be risk-free, such as fatigue or hair loss).
* Patients with active uncontrolled systemic bacterial, viral, or fungal infections despite optimal treatment.
* Significant liver or kidney dysfunction (i.e., laboratory values \>3 times the upper limit of normal).
* Active hepatitis B, hepatitis C, HIV, or syphilis.
* Brain disorders, symptomatic central nervous system (CNS) or meningeal metastases, or impaired cognitive function.
* Hypersensitivity to any drug included in the trial.
* Drug and/or alcohol abuse.
* Pregnant or breastfeeding women.
* Concurrent participation in another therapeutic clinical trial.
* Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within ≤14 days after intervention).
* Major surgery within 30 days.
* Use of antibiotics, antifungals, antivirals, antiparasitics, or probiotics within 4 weeks before enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07071103
Study Brief:
Protocol Section:
NCT07071103