Actively Recruiting
A Phase I Clinical Trial of Intratumoral Injection of Recombinant Human Endostatin Adenovirus Combined With Toripalimab for Recurrent or Metastatic Head and Neck Tumors
Led by West China Hospital · Updated on 2026-06-04
9
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and early antitumor effects of a new treatment combining recombinant human endostatin adenovirus injection (EDS01) with toripalimab in adults who have recurrent or metastatic head and neck tumors, including nasopharyngeal carcinoma. These patients have previously been treated with platinum-based chemotherapy or cannot undergo further platinum treatment. This study is a Phase 1 trial conducted at a single center to explore this combination in patients with limited treatment options. Participants will be divided into three groups receiving different doses of EDS01 injected directly into an accessible tumor lesion on Days 0 and 7. In addition, toripalimab will be given intravenously at a fixed dose of 240 mg on Day 1 of each 21-day treatment cycle. Treatment may continue for up to four cycles unless the disease worsens or side effects become unacceptable. The study will assess different dose levels of EDS01 combined with toripalimab to determine safety and feasibility. During the study, participants will undergo clinical assessments, physical exams, laboratory tests, and imaging scans to monitor tumor response and detect any adverse events. Tumor response will be measured using standard criteria (RECIST 1.1), focusing on objective response, disease control, and time to progression. Participants will be followed up every three months after treatment until disease progression or death. Additional tests include antibody monitoring and blood measurements related to the treatment. The total duration of follow-up may last up to three years.
CONDITIONS
Brief Title
Intratumoral Injection of Recombinant Human Endostatin Adenovirus (EDS01) for the Treatment of Recurrent or Metastatic Head and Neck Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Histologically or cytologically confirmed recurrent or metastatic head and neck tumor
- Previously received at least 1 standard platinum-based chemotherapy regimen for recurrent/metastatic disease or had platinum-insensitive or platinum-intolerant disease
- Not suitable for surgery or radiotherapy
- At least 1 accessible tumor lesion suitable for intratumoral injection
- At least 1 measurable lesion with diameter 2 cm on imaging according to RECIST 1.1
- No chemotherapy, radiotherapy, biologic antitumor therapy, or antiviral therapy within 4 weeks before enrollment
- Estimated life expectancy of at least 12 weeks
- ECOG performance status 0 to 1
- Male or female participants of childbearing potential must agree to use reliable contraception during treatment and for at least 6 months after treatment
- Recovery of prior treatment-related toxicities to NCI CTCAE grade 1 or baseline
- Screening laboratory results meeting protocol requirements within 1 week before enrollment
- Willing and able to provide written informed consent
You will not qualify if you...
- Known allergy to the study drugs
- Lesions involving major blood vessels or nerves unsuitable for local injection
- Receiving radiotherapy to the study lesion at the same time
- Prior anti-angiogenic therapy
- Receiving immunosuppressive therapy or systemic corticosteroids greater than prednisone 10 mg/day within 2 weeks before enrollment
- Active or history of autoimmune disease
- Congenital or acquired immunodeficiency
- Risk of major nasopharyngeal hemorrhage or deep nasopharyngeal ulceration
- Severe coagulation disorder or bleeding tendency
- Severe uncontrolled medical disease or myocardial infarction within 3 months before enrollment
- Acute infection
- Pregnant or breastfeeding women
- Any condition making the participant unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 weeks (4 cycles)
Participants receive intratumoral injections of recombinant human endostatin adenovirus (EDS01) on Days 0 and 7 plus intravenous toripalimab on Day 1 of each 21-day cycle. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.
2 visits per cycle (Days 0 and 7 for injections) plus 1 infusion visit per cycle (Day 1)
Duration - Up to 3 years
Participants are assessed every 3 months after treatment until disease progression or death to monitor safety and tumor response.
Visits every 3 months
Trial Site Locations
Total: 1 location
1
West China Hospital
Chengdu, China, China, 610041
Actively Recruiting
Research Team
N
nan lin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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