Endostatin Adenovirus With Checkpoint Inhibitor in Advanced Head and Neck or Esophageal Cancer (NCT07154108) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Endostatin Adenovirus With Checkpoint Inhibitor in Advanced Head and Neck or Esophageal Cancer
China40 participantsStarted 2025-09-01
Plain-language summary
This is a Phase I, open-label, dual-cohort clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of intratumoral injection of recombinant human endostatin adenovirus in combination with a PD-1 inhibitor in patients with recurrent or metastatic head and neck cancer, or in patients with esophageal squamous cell carcinoma (ESCC) with superficial lymph node metastasis.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years
✓. Histologically or cytologically confirmed recurrent or metastatic:
✓. Prior treatment:
✓. At least one lesion accessible for intratumoral injection
✓. ECOG performance status
✓. Adequate organ function
✓. Life expectancy ≥12 weeks (Cohort A)
✓. No anti-tumor therapy (chemotherapy, radiotherapy, biotherapy, antiviral) within 4 weeks prior to enrollment (Cohort A)
Exclusion criteria
✕. Known allergy or hypersensitivity to study drugs
✕. Lesions unsuitable for injection due to proximity to major blood vessels, nerves, or hollow organs, or with extensive necrosis
✕. Deeply located lesions with high procedural difficulty (Cohort B)
✕. Concurrent radiotherapy to target lesion(s) (Cohort A)
✕. Prior anti-angiogenic therapy (Cohort A)
✕. Immunosuppressive therapy or systemic corticosteroids \>10 mg/day prednisone (or equivalent) within 2 weeks prior to enrollment
What they're measuring
1
Incidence of treatment-related adverse effects (TRAEs)
Timeframe: Through study completion, an average of 1.5 year
2
Incidence of Dose-Limiting Toxicities (DLTs)
Timeframe: During the first cycle of treatment （21 days）