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

ConditionsEsophageal CancerHead and Neck Cancer (H&Amp;Amp;Amp;N)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cohort A (Head and Neck Cancer)

Cohort B (Esophageal Squamous Cell Carcinoma)

Age ≥18 years

Cohort A (Head and Neck Cancer): ≤70 years

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • recombinant human endostatin adenovirus

    Biological/Vaccine

    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 Inhibitor

    Drug

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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Endostatin Adenovirus+PD-1 inhibitorExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
During the first cycle of treatment （21 days）

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
up to 12 months
4

Overall Survival (OS)

Time from the start of treatment to death from any cause

Time frame
up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: