Clinical trial · Interventional
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
NCT07154108CI-TRIAL-00094487not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Head and Neck Cancer (H&Amp;Amp;Amp;N) | Malignant Head and Neck Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 Inhibitor | Drug | — | UNRESOLVED |
| recombinant human endostatin adenovirus | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endostatin Adenovirus+PD-1 inhibitor
- description
- 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. Immune checkpoint inhibitor: Administered via intravenous infusion once every 3 weeks. (This study includes two parallel cohorts: Cohort A (recurrent/metastatic head and neck cancer) and Cohort B (esophageal squamous cell carcinoma). Both cohorts will receive the same intervention.)
- interventionNames
- Biological: recombinant human endostatin adenovirus
- Drug: PD-1 Inhibitor
Primary outcomes (2)
- measure
- Incidence of treatment-related adverse effects (TRAEs)
- timeFrame
- Through study completion, an average of 1.5 year
- description
- This study will collected any adverse medical events that occurred during the study drug treatment, and the treatment related adverse events as assessed by CTCAE v5.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
* 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
References
Publications (0)
Data not yet available
No reference posted for this study.