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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT07154108
Eligibility Criteria:
* Cohort A (Head and Neck Cancer)
* Cohort B (Esophageal Squamous Cell Carcinoma)
Inclusion Criteria:
1. Age ≥18 years
* Cohort A (Head and Neck Cancer): ≤70 years
* Cohort B (Esophageal Squamous Cell Carcinoma): ≤75 years
2. Histologically or cytologically confirmed recurrent or metastatic:
* Cohort A: Head and Neck Cancer
* Cohort B: ESCC, AJCC 9th edition stage IV
3. Prior treatment:
* Cohort A: ≥1 prior platinum-based chemotherapy regimen or platinum-refractory/intolerant
* Cohort B: Prior immune checkpoint inhibitor (ICI) therapy with documented acquired resistance after prior PR or SD
4. At least one lesion accessible for intratumoral injection
* Cohort A: measurable lesion ≥2 cm by RECIST 1.1
* Cohort B: superficial metastatic lymph nodes (cervical or supraclavicular)
5. ECOG performance status
* Cohort A: 0-2
* Cohort B: 0-1
6. Adequate organ function
7. Life expectancy ≥12 weeks (Cohort A)
8. No anti-tumor therapy (chemotherapy, radiotherapy, biotherapy, antiviral) within 4 weeks prior to enrollment (Cohort A)
9. Availability of fresh tumor tissue specimen or pathological slides from the injection target lesion (Cohort B)
10. Male/female patients of childbearing potential must use effective contraception during study and for at least 6 months after treatment
11. Voluntary participation with signed informed consent
Exclusion Criteria:
1. Known allergy or hypersensitivity to study drugs
2. Lesions unsuitable for injection due to proximity to major blood vessels, nerves, or hollow organs, or with extensive necrosis
3. Deeply located lesions with high procedural difficulty (Cohort B)
4. Concurrent radiotherapy to target lesion(s) (Cohort A)
5. Prior anti-angiogenic therapy (Cohort A)
6. Immunosuppressive therapy or systemic corticosteroids \>10 mg/day prednisone (or equivalent) within 2 weeks prior to enrollment
7. Active autoimmune disease or history of autoimmune disease
8. Congenital or acquired immunodeficiency
9. Severe coagulopathy, bleeding tendency, or high-risk lesions (Cohort B)
10. Poor nutritional status (Cohort B)
11. Interstitial lung disease with symptoms or radiographic evidence (Cohort B)
12. Severe uncontrolled systemic disease or recent myocardial infarction (\<3 months)
13. Acute infection
14. Pregnancy or breastfeeding
15. Other malignancy besides ESCC (Cohort B)
16. Patients unlikely to comply with follow-up or participation requirements
17. Any condition deemed unsuitable for enrollment by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07154108
Study Brief:
Protocol Section:
NCT07154108