NCT07154108Not yet recruitingPhase 1
Endostatin Adenovirus With Checkpoint Inhibitor in Advanced Head and Neck or Esophageal Cancer
A Phase I, Open-label, Two-cohort Study of Recombinant Human Endostatin Adenovirus in Combination With Immune Checkpoint Inhibitors in Patients With Recurrent or Metastatic Head and Neck Cancer or Esophageal Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 4 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 27 Aug 2025
- Start date
- Sept 2025
- Primary completion date
- Aug 2027
- Lead sponsor
- Sichuan University
- NCT number
- NCT07154108
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 40
- From Sept 2025 to the primary completion date, Aug 2027
- 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
- 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
Other illness
- Known allergy or hypersensitivity to study drugs
- Active autoimmune disease or history of autoimmune disease
- Severe coagulopathy, bleeding tendency, or high-risk lesions (Cohort B)
- Interstitial lung disease with symptoms or radiographic evidence (Cohort B)
- Severe uncontrolled systemic disease or recent myocardial infarction (\<3 months)
- Acute infection
- Other malignancy besides ESCC (Cohort B)
- Any condition deemed unsuitable for enrollment by the investigator
Other
- 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)
- Congenital or acquired immunodeficiency
- Poor nutritional status (Cohort B)
- Pregnancy or breastfeeding
- Patients unlikely to comply with follow-up or participation requirements
Who the study is looking for
- Age ≥18 years
- Cohort A (Head and Neck Cancer): ≤70 years
- Cohort B (Esophageal Squamous Cell Carcinoma): ≤75 years
- Histologically or cytologically confirmed recurrent or metastatic:
- Cohort A: Head and Neck Cancer
- Cohort B: ESCC, AJCC 9th edition stage IV
- 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
- 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)
- ECOG performance status
- Cohort A: 0-2
- Cohort B: 0-1
- 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)
- Availability of fresh tumor tissue specimen or pathological slides from the injection target lesion (Cohort B)
- Male/female patients of childbearing potential must use effective contraception during study and for at least 6 months after treatment
- Voluntary participation with signed informed consent
Criteria the registry did not label
- Cohort A (Head and Neck Cancer)
- Cohort B (Esophageal Squamous Cell Carcinoma)
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.