A Phase 1 interventional study of EDS01 1.0×10^11 VP + Toripalimab and EDS01 5.0×10^11 VP + Toripalimab in Head & Neck Cancer and Nasopharyngeal Cancinoma (NPC), sponsored by West China Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by West China Hospital · Phase 1, Interventional, and Treatment
Among 19 studies in Head and Neck Neoplasms by West China Hospital — 10 open to participants now, 11 under way, 2 of them phase 3. Head and Neck Neoplasms · West China Hospital.
Among the 19 studies in Head and Neck Neoplasms by West China Hospital, this one is the 13th largest by planned enrollment of the 17 interventional ones that give a count, is one of 7 that started in 2026, is one of 5 in phase 1, reaches primary completion later than 10 of the 10 other live ones, and was the 14th registered.
2,713 studies on the registry are indexed under Head and Neck Neoplasms; 596 are open to participants now.
Browse Head and Neck Neoplasms studies →10 of the 19 studies in Head and Neck Neoplasms by West China Hospital are open now, in 1 country. Recruiting first, the newest first:
West China Hospital · Sites in China
Ages 18–80
West China Hospital · Sites in China
Ages 18–80
West China Hospital · Sites in China
Ages 18–75
West China Hospital · Sites in China
Ages 18–80
West China Hospital · Sites in China
Ages 18–80
By country, each count listing its studies:
Of the 453 Head and Neck Neoplasms studies recruiting now, 345 (76%) set no upper age limit and 51 (11%) stop at 75 or younger; 21 take children under 18; 27 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
19 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 8 · Phase 3 2
First in 2020; this study’s year is marked. 7 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 9 is below the median of 46 across 2,033 interventional studies indexed under Head and Neck Neoplasms.
Median enrollment 40 across the 17 interventional studies, 12 across the 2 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
West China Hospital is the lead sponsor of 501 studies on the registry; 246 are open to participants now.
7 of the studies in Head and Neck Neoplasms by West China Hospital that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07353671Phase 3West China HospitalTopical Periplaneta Americana-Derived Meilian Fuxin Liquid for Radiation Dermatitis | 2026-12-31 |
| NCT07467083Phase 3West China HospitalDevelopment and Application of a Nurse-Led Preemptive Symptom Management Protocol for Head and Neck Cancer Patients Undergoing Radiation Therapy | 2027-03-01 |
| NCT07635277West China HospitalAkkermansia Muciniphila (AKK) for Radiation-Induced Skin Injury | 2026-11-30 |
| NCT07704372West China HospitalSuperoxide Dismutase Skin Spray for the Prevention of Acute Radiation Dermatitis in Head and Neck Cancer | 2027-01-31 |
| NCT07583914West China HospitalSafety, Tolerability, and Preliminary Antitumor Activity of Non-Cationic Peptide-CD47 siRNA in Advanced Solid Tumors | 2027-06-30 |
Add all 7 to your calendar (.ics) → With an account.
Among the 19 studies in Head and Neck Neoplasms by West China Hospital, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This single-center, Phase 1 study is evaluating the safety, tolerability, and preliminary antitumor activity of recombinant human endostatin adenovirus injection (EDS01) given by intratumoral injection in combination with toripalimab in adults with recurrent or metastatic head and neck tumors, including nasopharyngeal carcinoma, whose disease has progressed after platinum-based systemic therapy or who are not suitable for further platinum treatment.
A total of 9 participants will be enrolled in 3 planned dose groups of EDS01. EDS01 will be injected directly into an accessible tumor lesion on Days 0 and 7, and toripalimab 240 mg will be administered intravenously on Day 1 of each treatment cycle for up to 4 cycles, unless disease progression or unacceptable toxicity occurs. The study will evaluate treatment-related adverse events as well as preliminary efficacy outcomes, including tumor response, disease control, and time to progression, using clinical assessments, laboratory tests, imaging, and follow-up after treatment.
Patients with recurrent or metastatic head and neck tumors, including nasopharyngeal carcinoma, have limited treatment options after failure of platinum-based therapy. Anti-programmed cell death protein 1 (PD-1) therapy is an established later-line treatment option in this setting. EDS01 is a recombinant human endostatin adenovirus injection designed for intratumoral administration. By delivering the human endostatin gene into tumor cells, EDS01 is intended to support sustained local expression of endostatin and inhibit tumor angiogenesis. Head and neck lesions are often accessible for direct intratumoral injection and serial local assessment, which makes this disease setting suitable for evaluation of this approach. Prior early-phase clinical experience with EDS01 in advanced head and neck tumors showed that the main observed toxicities were fever, injection-site pain, and flu-like symptoms, without dose-limiting toxicity or serious adverse events at the studied dose levels, and preliminary antitumor activity was observed. These findings support further evaluation of EDS01 in combination with PD-1 blockade.
This single-center Phase 1 study is designed to evaluate the safety, tolerability, and preliminary antitumor activity of EDS01 in combination with toripalimab in adults with recurrent or metastatic head and neck tumors who have previously received platinum-based treatment or demonstrated platinum insensitivity or intolerance, and who have an injectable tumor lesion. The study will explore planned EDS01 dose levels in combination with fixed-dose toripalimab in order to characterize the safety profile of the regimen and identify whether the combination is feasible for further clinical development.
Study evaluations include clinical assessments, physical examinations, laboratory testing, and monitoring of adverse events and serious adverse events. Tumor response will be assessed radiographically according to RECIST version 1.1, including evaluation of objective response, disease control, and time to progression. Additional translational and exploratory assessments include anti-adenovirus antibody testing, serum endostatin measurement, and selected monitoring related to environmental shedding after intratumoral administration. After treatment, participants will enter follow-up and be assessed every 3 months until disease progression or death.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adults aged 18 to 65 years. or cytologically confirmed recurrent or head and neck tumor.
Previously received at least 1 standard platinum-based systemic chemotherapy regimen for recurrent/metastatic disease, or had platinum-insensitive or platinum-intolerant disease after prior curative-intent treatment.
Not suitable for surgery or radiotherapy. At least 1 target lesion suitable for intratumoral injection of recombinant human endostatin adenovirus injection.
At least 1 with diameter ≥2 cm on imaging, according to version 1.1.
No chemotherapy, radiotherapy, biologic antitumor therapy, or antiviral therapy within 4 weeks before enrollment.
Estimated of at least 12 weeks. performance status 0 to 1. Male or female participants of must agree to use reliable during treatment and for at least 6 months after treatment.
Recovery of prior treatment-related toxicities to grade 1 or baseline, with screening laboratory results within 1 week before enrollment meeting protocol requirements: ≥1.5×10\^9/L, count ≥80×10\^9/L, total ≤1.5 × , and AST ≤2 × ULN, and coagulation parameters ≤1.25 × ULN.
Willing and able to provide written .
Exclusion Criteria:
Known allergy to the study drugs. Lesions involving major blood vessels or nerves and therefore unsuitable for local injection.
Receiving radiotherapy to the study lesion at the same time. Prior anti-angiogenic therapy. Receiving therapy or systemic for immunosuppressive purposes at a dose greater than prednisone 10 mg/day (or equivalent) within 2 weeks before enrollment.
Active disease 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 that, in the investigator's judgment, makes the participant unsuitable for enrollment.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive intratumoral EDS01 1.0×10\^11 viral particles (VP) on Days 0 and 7 plus toripalimab 240 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.
Drug: EDS01 1.0×10^11 VP + Toripalimab
Participants receive intratumoral EDS01 5.0×10\^11 viral particles (VP) on Days 0 and 7 plus toripalimab 240 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.
Drug: EDS01 5.0×10^11 VP + Toripalimab
Participants receive intratumoral EDS01 1.0×10\^12 viral particles (VP) on Days 0 and 7 plus toripalimab 240 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.
Drug: EDS01 1.0×10^12 VP + Toripalimab
Drug page: Toripalimab
Recombinant human endostatin adenovirus injection (EDS01) is administered by intratumoral injection into an accessible tumor lesion on Days 0 and 7 of each 21-day cycle. Three planned dose levels are evaluated across study cohorts: 1.0×10\^11 VP. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.
Drug page: Toripalimab
Recombinant human endostatin adenovirus injection (EDS01) is administered by intratumoral injection into an accessible tumor lesion on Days 0 and 7 of each 21-day cycle. Three planned dose levels are evaluated across study cohorts: 5.0×10\^11 VP. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.
Drug page: Toripalimab
Recombinant human endostatin adenovirus injection (EDS01) is administered by intratumoral injection into an accessible tumor lesion on Days 0 and 7 of each 21-day cycle. Three planned dose levels are evaluated across study cohorts: 1.0×10\^12 VP. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Number and percentage of participants with adverse events (AEs), serious adverse events (SAEs), treatment-related adverse events, and clinically significant abnormal laboratory findings. Adverse events will be graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC), version 4.0. Safety evaluation will also include physical examination findings and environmental shedding monitoring related to intratumoral administration of EDS01.
Time frame: From signing informed consent through 1 month after the end of treatment (up to 16 weeks).
Objective response rate of target lesions
Proportion of participants with complete response (CR) or partial response (PR) in target lesions. Tumor response will be assessed according to RECIST version 1.1.
Time frame: From baseline until disease progression or end of treatment, whichever occurs first (up to 3 years).
Disease control rate of target lesions
Proportion of participants with complete response (CR), partial response (PR), or stable disease (SD) in target lesions, assessed according to RECIST version 1.1.
Time frame: From baseline until disease progression or end of treatment, whichever occurs first (up to 3 years).
Overall objective response rate of all lesions
Proportion of participants with complete response (CR) or partial response (PR) in overall lesions, assessed according to RECIST version 1.1.
Time frame: From baseline until disease progression or end of treatment, whichever occurs first (up to 3 years).
Time to progression (TTP)
Time from enrollment to the first documented disease progression. Deaths before progression will be censored.
Time frame: From enrollment until first documented disease progression; participants will be followed every 3 months after treatment until progression or death. Up to 3 years from enrollment.
Change in serum anti-adenovirus IgG
Change in serum anti-adenovirus (ADV) IgG from baseline to post-baseline assessments, measured by ELISA.
Time frame: From signing informed consent through 1 month after the end of treatment (up to approximately 16 weeks).
Plan to share: Yes
Supporting information: Study protocol
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Mar 2028, 24 months after the start.
Of 90 non-industry phase 1 interventional studies under Head and Neck Neoplasms, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 63. This study's planned 24 months is below that.
Counting every sponsor, half of 176 studies reached it within 45 months; a quarter within 31 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Toripalimab