Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07154108

PHASE1

Endostatin Adenovirus With Checkpoint Inhibitor in Advanced Head and Neck or Esophageal Cancer

Sponsor: Sichuan University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-09-01

Completion Date

2027-08-01

Last Updated

2025-09-04

Healthy Volunteers

Conditions

Esophageal Cancer Head and Neck Cancer (H&Amp;Amp;Amp;N)

Interventions

BIOLOGICAL

recombinant human endostatin adenovirus

Recombinant Human Endostatin Adenovirus: Administered via intratumoral injection twice every 3 weeks for a total of eight doses, or until disease progression, the occurrence of unacceptable toxicity, or death from any cause, whichever occurs first.

DRUG

PD-1 Inhibitor

PD-1 inhibitor: Administered via intravenous infusion once every 3 weeks.

* 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

Locations (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China