Endostatin Adenovirus With Checkpoint Inhibitor in Advanced Head and Neck or Esophageal Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan University
About this trial
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.
Eligibility criteria
Qualifiers
Cohort A (Head and Neck Cancer)
Cohort B (Esophageal Squamous Cell Carcinoma)
Age ≥18 years
Cohort A (Head and Neck Cancer): ≤70 years
Disqualifiers
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)
Trial design
Treatments tested in this trial
- recombinant human endostatin adenovirus
- PD-1 Inhibitor
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov