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

NCT07154108 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: AdEndo-PD1-P1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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)

Keywords

Esophageal cancer; Esophageal squamous cell carcinoma; Head and neck cancer; Endostatin Adenovirus; safety; Clinical efficacy

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment-related adverse effects (TRAEs)

  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.

  Through study completion, an average of 1.5 year

• Incidence of Dose-Limiting Toxicities (DLTs)

  DLTs are defined as treatment-related adverse events occurring during the DLT evaluation period that meet protocol-specified criteria for severity and duration, as assessed by NCI CTCAE v5.0.

  During the first cycle of treatment （21 days）

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  up to 12 months

• Disease Control Rate (DCR)

  up to 12 months

• Progression-Free Survival (PFS)

  up to 12 months

• Overall Survival (OS)

  up to 24 months

Study Arms (1)

Endostatin Adenovirus+PD-1 inhibitor

EXPERIMENTAL

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.)

Biological: recombinant human endostatin adenovirus; Drug: PD-1 Inhibitor

Interventions

recombinant human endostatin adenovirus BIOLOGICAL

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.

Endostatin Adenovirus+PD-1 inhibitor

PD-1 Inhibitor DRUG

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

Endostatin Adenovirus+PD-1 inhibitor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Head and Neck Neoplasms; Esophageal Squamous Cell Carcinoma

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Zhenyu Ding, MD

CONTACT

+862885422562; dingzhenyu@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: * Cohort A (Head and Neck Cancer): Patients with recurrent or metastatic head and neck cancer; single-arm, open-label; N ≈ 20 * Cohort B (Esophageal Squamous Cell Carcinoma): Patients with superficial lymph node metastasis of ESCC; single-arm, open-label; N ≈ 20

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 4, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)