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

NCT07154108 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-04

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Sichuan University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-08-01
Completion
2027-08-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07154108 on ClinicalTrials.gov