Status:
NOT_YET_RECRUITING
Endostatin Adenovirus With Checkpoint Inhibitor in Advanced Head and Neck or Esophageal Cancer
Lead Sponsor:
Sichuan University
Conditions:
Esophageal Cancer
Head and Neck Cancer (H&Amp;Amp;Amp;N)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 i...
Detailed Description
Cohort A will enroll patients with recurrent or metastatic head and neck cancer. Cohort B will enroll patients with ESCC with superficial lymph node metastasis. Both cohorts will receive intratumoral ...
Eligibility Criteria
Inclusion
- Cohort A (Head and Neck Cancer)
- Cohort B (Esophageal Squamous Cell Carcinoma)
- 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
Exclusion
- 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
- Active autoimmune disease or history of autoimmune disease
- Congenital or acquired immunodeficiency
- Severe coagulopathy, bleeding tendency, or high-risk lesions (Cohort B)
- Poor nutritional status (Cohort B)
- Interstitial lung disease with symptoms or radiographic evidence (Cohort B)
- Severe uncontrolled systemic disease or recent myocardial infarction (\<3 months)
- Acute infection
- Pregnancy or breastfeeding
- Other malignancy besides ESCC (Cohort B)
- Patients unlikely to comply with follow-up or participation requirements
- Any condition deemed unsuitable for enrollment by the investigator
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07154108
Start Date
September 1 2025
End Date
August 1 2027
Last Update
September 4 2025
Active Locations (1)
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1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041