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AzTrials

Esophageal CancerPhase 1NCT07154108

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

A Phase 1 study testing recombinant human endostatin adenovirus and PD-1 Inhibitor in people with Esophageal Cancer and Head and Neck Cancer (H&Amp;Amp;Amp;N), run by Sichuan University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
recombinant human endostatin adenovirus and PD-1 Inhibitor
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
1 Sep 2025to 1 Aug 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhenyu Ding, MD contact

+862885422562

dingzhenyu@scu.edu.cn

China1 site

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Zhenyu Ding, MD, +862885422562, dingzhenyu@scu.edu.cn

Other trials in China

About this study

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

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.

Read the 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 injection of recombinant human endostatin adenovirus combined with intravenous an immune checkpoint inhibitor.

The primary objectives are to assess the safety profile, incidence of dose-limiting toxicities (DLTs), and treatment-related adverse events (TRAEs) of the combination therapy. The secondary objectives include evaluation of objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). Each cohort plans to enroll approximately 20 patients, with a total of 40 participants.

Being tested
recombinant human endostatin adenovirus, PD-1 Inhibitor
Keywords
Esophageal cancer, Esophageal squamous cell carcinoma, Head and neck cancer, Endostatin Adenovirus, safety, Clinical efficacy
Medical subject headings
Esophageal Neoplasms, Head and Neck Neoplasms, Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • recombinant human endostatin adenovirusBiological

    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.

  • PD-1 InhibitorDrug

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

Study groups in NCT07154108
Study groupRoleWhat they receive
Endostatin Adenovirus+PD-1 inhibitorExperimentalRecombinant 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.)
Receives: Biological: recombinant human endostatin adenovirus; Drug: PD-1 Inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through study completion, an average of 1.5 year

  2. 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.

    Measured: During the first cycle of treatment （21 days）

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    It is defined as the proportion of patients with complete response (CR) or partial response (PR), as assessed by RECIST 1.1.

    Measured: up to 12 months

  2. Disease Control Rate (DCR)

    DCR refers to the proportion of patients who achieve complete response (CR), partial response (PR), or stable disease (SD) for a specified minimum duration after treatment, based on RECIST 1.1.

    Measured: up to 12 months

  3. Progression-Free Survival (PFS)

    Time from the start of treatment to the first documentation of disease progression based on RECIST 1.1.

    Measured: up to 12 months

  4. Overall Survival (OS)

    Time from the start of treatment to death from any cause

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
* 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
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07154108
Sponsor's protocol ID
AdEndo-PD1-P1
Status last verified
Aug 2025
First submitted
27 Aug 2025
Last updated
4 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing recombinant human endostatin adenovirus and PD-1 Inhibitor in people with Esophageal Cancer and Head and Neck Cancer (H&Amp;Amp;Amp;N), run by Sichuan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhenyu Ding, MD (+862885422562, dingzhenyu@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-related adverse effects (TRAEs) (time frame: Through study completion, an average of 1.5 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07154108.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.

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