HNSCCPhase 2NCT07491783
Nano-Carbon Iron Suspension Injection Combined With Radiotherapy for Solid Tumors Phase II Clinical Trial
A Phase 2 study testing Carbon Nanoparticle Iron Suspension for Injection in people with HNSCC and Soft Tissue Cancer, run by Sichuan Enray Pharmaceutical Sciences Company at 1 site in China.
Trial summary
Study Primary Objective: To evaluate the efficacy of CNSI-Fe intra-tumoral injection combined with radiotherapy in patients with solid tumors. Study Secondary Objectives: 1. To evaluate the efficacy of CNSI-Fe intra-tumoral injection combined with radiotherapy at both injected and non-injected lesions; 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HNSCC, Soft Tissue Cancer
- What is being tested?
- Carbon Nanoparticle Iron Suspension for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2026to 30 Dec 2028
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants voluntarily sign a written Informed Consent Form (ICF), can communicate effectively with the investigator, and are able to comply with study requirements.
- Age ≥ 18 years and ≤ 80 years, regardless of gender.
- Histologically or cytologically confirmed solid tumors, including soft tissue sarcoma, head and neck squamous cell carcinoma, etc., assessed by the investigator as suitable for standard radiotherapy, including preoperative neoadjuvant radiotherapy (Cohort A1) or definitive radiotherapy for patients unsuitable for surgery (Cohort A2).
- ECOG score of 0-1.
- Estimated survival ≥ 12 weeks.
- Limited oligometastasis (≤ 5 lesions).
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- According to RECIST 1.1 criteria, participants have at least one radiologically measurable lesion that has not previously received radiotherapy (unless the lesion progressed clearly after radiotherapy).
- At least one injectable lesion (e.g., directly injectable or via medical imaging guidance), determined by the investigator to be suitable for repeated intratumoral injection.
- Drug-related adverse reactions from prior treatments have recovered to Grade 1 or lower per NCI CTCAE v6.0 at screening (excluding alopecia, Grade 2 or lower peripheral neurotoxicity, or other toxicities judged by the investigator to pose low safety risk).
- Left ventricular ejection fraction (LVEF) ≥ 50% assessed by cardiac evaluation.
- Within 7 days prior to first dosing, adequate hematologic and end organ function per laboratory tests meeting the following criteria:
- Hematology No use of granulocyte colony-stimulating factor (G-CSF) or similar treatments within 14 days prior to hematology lab testing, and absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; No platelet transfusion or use of interleukin-11 (IL-11), recombinant human thrombopoietin injection, or similar treatments within 7 days prior to hematology lab testing, and platelet count (PLT) ≥ 90×10⁹/L; No blood transfusion or use of erythropoietin within 14 days prior to hematology lab testing, and hemoglobin (Hb) ≥ 90 g/L;
- Coagulation function International normalized ratio (INR) ≤ 1.5×upper limit of normal (ULN), activated partial thromboplastin time (APTT) ≤ 1.5×ULN; Note: Participants receiving anticoagulant therapy with injectable lesions in the skin and/or subcutaneous tissue may have prolonged INR and APTT as direct pressure can control excessive bleeding, determined by the investigator; for participants receiving anticoagulant therapy and undergoing deep lesion injection, discontinuation of anticoagulant therapy for at least 1 week prior to injection is recommended, determined by the investigator.
- Renal function Serum creatinine (Cr) ≤ 1.5×ULN, or calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault formula (creatinine clearance calculation is performed only when baseline Cr > 1.5×ULN);
- Hepatic function total bilirubin (TBIL) ≤ 1.5×ULN, or ≤ 3×ULN for participants with Gilbert's syndrome or hepatic metastases; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) concentrations ≤ 3×ULN, or ≤ 5×ULN if elevated due to hepatic metastases as determined by the investigator; Serum albumin ≥ 2.8 g/dL.
- Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dosing of study drug, commit to practicing effective contraception or abstinence during the study drug treatment period and for 6 months after completion of study drug treatment, and must not be lactating.
- Male participants must commit to practicing effective contraception or abstinence during the study drug treatment period and for 6 months after completion of study drug treatment. Additionally, male participants must agree not to donate sperm during this period.
Who cannot join
- History or current diagnosis of iron metabolism disorders (excluding participants with iron deficiency anemia), such as thalassemia, favism (red blood cell glucose-6-phosphate dehydrogenase deficiency), etc.
- Evidence of hollow viscus perforation at the injection site either previously or currently.
- Local skin ulceration, erythema, necrosis, hemorrhage or other conditions affecting investigational drug administration at the injection site either previously or currently.
- Known history or current coagulation defects causing increased bleeding risk, or any known hemorrhagic disorders.
- Received systemic chemotherapy, small molecule targeted therapy or hormonal anti-tumor treatment within 2 weeks prior to first administration of investigational medication; received macromolecular biologics anti-tumor treatment within 4 weeks prior to first administration of investigational medication; received prior radiotherapy within 14 days prior to first administration of investigational medication [central nervous system (CNS) radiotherapy excluded, requiring ≥28 days washout period]; received traditional Chinese medicine with anti-tumor indication within 14 days prior to first administration of investigational medication.
- Undergone major surgical procedures (craniotomy, thoracotomy or laparotomy) within 4 weeks prior to first administration of investigational medication, or other surgical conditions deemed unsuitable for enrollment by the investigator (fine needle aspiration at tumor site is allowed).
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- Contraindications for concomitant therapy: infection, active inflammation, severe skin lesions or other conditions deemed unsuitable for radiotherapy at the intended irradiation sites;
- Untreated or active brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence indicating uncontrolled central nervous system metastases (excluding cases with stable symptoms after treatment, radiological evidence of stability for at least 4 weeks prior to first administration, absence of cerebral edema evidence, and no requirement for corticosteroid treatment).
- Uncontrolled or poorly controlled hypertension (e.g., systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg).
- Uncontrolled tumor-related pain.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once/month or more frequently).
- Received live virus vaccination within 4 weeks prior to first administration of investigational medication.
- History of immunodeficiency disease, including human immunodeficiency virus (HIV) positive status or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
- Active hepatitis B virus (HBV) infection [HBV DNA quantitative >500 IU/mL], or hepatitis C virus (HCV) infection [HCV antibody positive with HCV ribonucleic acid (RNA) polymerase chain reaction (PCR) exceeding upper limit of normal].
- Severe chronic or active infection (including tuberculosis infection) requiring systemic antibacterial, antifungal or antiviral treatment prior to first administration of investigational medication, viral hepatitis participants receiving antiviral treatment are allowed.
- Other active malignancies outside the study tumor type occurred within 5 years prior to first administration of investigational medication, excluding non-melanoma skin cancers treated with curative intent, localized prostate cancer, ductal carcinoma in situ, stage I endometrial cancer, cervical carcinoma in situ, differentiated thyroid cancer or breast carcinoma in situ.
- History of severe heart failure, stroke or transient ischemic attack within 6 months prior to first administration of investigational medication. History of ventricular tachycardia or torsade de pointes arrhythmia within 14 days prior to first administration, and any clinically significant abnormalities in rhythm, conduction or morphology on resting ECG. Diagnosed with clinically significant cardiac diseases including acute myocardial infarction, III or IV class congestive heart failure (New York Heart Association classification, see Appendix 3), unstable angina pectoris or arrhythmias requiring treatment within 6 months prior to first administration. Note: Participants with arrhythmia receiving anti-arrhythmic medication with controlled heart rate rhythm as shown on screening ECG may be enrolled.
- Participated in other interventional clinical studies within 3 weeks prior to first administration of investigational medication (calculated from the day after last administration in previous study, excluding cases without exposure to investigational drugs or medical devices).
- Diagnosed with active psychiatric disorders (schizophrenia, major depressive disorder, bipolar disorder, etc.).
- Participants with known allergy or intolerance to active ingredients or excipients in the investigational medication.
- Other conditions 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.
China1 site
West China Hospital, Sichuan University
Chengdu, Sichuan
Na Li, 028-85422654, huaxilunli@163.com
Yongsheng Wang
About this study
Official title: A Multicenter, Open-label Phase II Clinical Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Intratumoral Injection of Carbon Nanoparticle Iron Suspension (CNSI-Fe) in Combination With Radiotherapy in Patients With Solid Tumors
Study Primary Objective: To evaluate the efficacy of CNSI-Fe intra-tumoral injection combined with radiotherapy in patients with solid tumors.
Study Secondary Objectives:
Read more
- To evaluate the efficacy of CNSI-Fe intra-tumoral injection combined with radiotherapy at both injected and non-injected lesions;
- To evaluate the safety and tolerability of CNSI-Fe intra-tumoral injection combined with radiotherapy in patients with solid tumors;
- To evaluate the pharmacokinetic (PK) characteristics of CNSI-Fe intra-tumoral injection combined with radiotherapy in patients with solid tumors.
Study Population: Patients with histologically or cytologically confirmed solid tumors including soft tissue sarcoma, head and neck squamous cell carcinoma, etc., who are assessed by the investigator as suitable for standard radiotherapy including preoperative neoadjuvant radiotherapy (Cohort A1) or definitive radiotherapy for patients not suitable for surgery (Cohort A2)
Study Drug Administration Schedule: Single administration, 2 weeks per administration cycle, total 1-4 cycles
Study Primary Endpoint: Objective Response Rate (ORR) assessed according to RECIST 1.1 criteria
Study Key Secondary Endpoints:
- Patients with unresectable locally advanced or advanced solid tumors: Local Control Rate (LCR), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DOR), Time to Progression (TTP), Time to Response (TTR), and Overall Survival (OS);
- Patients receiving preoperative neoadjuvant therapy: Major Pathological Response (MPR), Disease-Free Survival (DFS), Disease Control Rate (DCR);
- Conditions
- HNSCC, Soft Tissue Cancer
- Being tested
- Carbon Nanoparticle Iron Suspension for Injection
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon Nanoparticle Iron Suspension for InjectionDrug
Dosage Form: Injection Strength: 2 mL: 100 mg Dosage and Administration: Mix 0.5 mL Carbon Nanoparticle Suspension for Injection with 30 mg Iron(II) Sulfate for Injection, administer intratumorally according to the recommended dosage (calculated as Fe²⁺, single dose not exceeding 150 mg) Treatment Schedule: Single administration, 2 weeks per administration cycle, total administration of 1-4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Dosage Form: Injection Strength: 2 mL: 100 mg Dosage and Administration: Mix 0.5 mL of carbon nanoparticle suspension injection with 30 mg of ferrous sulfate for injection, and administer intratumorally according to the recommended dose (calculated as Fe²⁺, single dose not exceeding 150 mg) Duration of Drug Administration: Single dose, with a 2-week cycle, administering a total of 1 to 4 cycles Receives: Drug: Carbon Nanoparticle Iron Suspension for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) assessed according to RECIST 1.1 criteria
the proportion of participants who achieve complete response (CR) and partial response (PR) after treatment.
Measured: From date ofrandomization , assessed up to 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start27 Mar 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HNSCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Enray Pharmaceutical Sciences Company
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital
- Responsible party
- Sponsor
- Investigators
- Yongsheng Wang, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491783
- Sponsor's protocol ID
- YR-2025-01-CNSI-Fe
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Phase II Clinical Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Intratumoral Injection of Carbon Nanoparticle Iron Suspension (CNSI-Fe) in Combination With Radiotherapy in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT07491783
- Acronym / sponsor ID
- YR-2025-01-CNSI-Fe
- Conditions
- HNSCC, Soft Tissue Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Sichuan Enray Pharmaceutical Sciences CompanyUniversity, hospital or other
- Collaborators
- West China Hospital
- Study start
- 27 Mar 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Primary Objective: To evaluate the efficacy of CNSI-Fe intra-tumoral injection combined with radiotherapy in patients with solid tumors.
Study Secondary Objectives:
- To evaluate the efficacy of CNSI-Fe intra-tumoral injection combined with radiotherapy at both injected and non-injected lesions;
- To evaluate the safety and tolerability of CNSI-Fe intra-tumoral injection combined with radiotherapy in patients with solid tumors;
- To evaluate the pharmacokinetic (PK) characteristics of CNSI-Fe intra-tumoral injection combined with radiotherapy in patients with solid tumors.
Study Population: Patients with histologically or cytologically confirmed solid tumors including soft tissue sarcoma, head and neck squamous cell carcinoma, etc., who are assessed by the investigator as suitable for standard radiotherapy including preoperative neoadjuvant radiotherapy (Cohort A1) or definitive radiotherapy for patients not suitable for surgery (Cohort A2)
Study Drug Administration Schedule: Single administration, 2 weeks per administration cycle, total 1-4 cycles
Study Primary Endpoint: Objective Response Rate (ORR) assessed according to RECIST 1.1 criteria
Study Key Secondary Endpoints:
- Patients with unresectable locally advanced or advanced solid tumors: Local Control Rate (LCR), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DOR), Time to Progression (TTP), Time to Response (TTR), and Overall Survival (OS);
- Patients receiving preoperative neoadjuvant therapy: Major Pathological Response (MPR), Disease-Free Survival (DFS), Disease Control Rate (DCR);
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Carbon Nanoparticle Iron Suspension for InjectionDosage Form: Injection Strength: 2 mL: 100 mg Dosage and Administration: Mix 0.5 mL of carbon nanoparticle suspension injection with 30 mg of ferrous sulfate for injection, and administer intratumorally according to the recommended dose (calculated as Fe²⁺, single dose not exceeding 150 mg) Duration of Drug Administration: Single dose, with a 2-week cycle, administering a total of 1 to 4 cycles |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Participants voluntarily sign a written Informed Consent Form (ICF), can communicate effectively with the investigator, and are able to comply with study requirements.
- Age ≥ 18 years and ≤ 80 years, regardless of gender.
- Histologically or cytologically confirmed solid tumors, including soft tissue sarcoma, head and neck squamous cell carcinoma, etc., assessed by the investigator as suitable for standard radiotherapy, including preoperative neoadjuvant radiotherapy (Cohort A1) or definitive radiotherapy for patients unsuitable for surgery (Cohort A2).
- ECOG score of 0-1.
- Estimated survival ≥ 12 weeks.
Key exclusion criteria (21 listed)
- History or current diagnosis of iron metabolism disorders (excluding participants with iron deficiency anemia), such as thalassemia, favism (red blood cell glucose-6-phosphate dehydrogenase deficiency), etc.
- Evidence of hollow viscus perforation at the injection site either previously or currently.
- Local skin ulceration, erythema, necrosis, hemorrhage or other conditions affecting investigational drug administration at the injection site either previously or currently.
- Known history or current coagulation defects causing increased bleeding risk, or any known hemorrhagic disorders.
- Received systemic chemotherapy, small molecule targeted therapy or hormonal anti-tumor treatment within 2 weeks prior to first administration of investigational medication; received macromolecular biologics anti-tumor treatment within 4 weeks prior to first administration of investigational medication; received prior radiotherapy within 14 days prior to first administration of investigational medication [central nervous system (CNS) radiotherapy excluded, requiring ≥28 days washout period]; received traditional Chinese medicine with anti-tumor indication within 14 days prior to first administration of investigational medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon Nanoparticle Iron Suspension for InjectionDosage Form: Injection Strength: 2 mL: 100 mg Dosage and Administration: Mix 0.5 mL Carbon Nanoparticle Suspension for Injection with 30 mg Iron(II) Sulfate for Injection, administer intratumorally according to the recommended dosage (calculated as Fe²⁺, single dose not exceeding 150 mg) Treatment Schedule: Single administration, 2 weeks per administration cycle, total administration of 1-4 cycles | Drug | Treatment Group |
Primary outcome
Objective response rate (ORR) assessed according to RECIST 1.1 criteria
Time frame: From date ofrandomization , assessed up to 6months
the proportion of participants who achieve complete response (CR) and partial response (PR) after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yongsheng Wang principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carbon Nanoparticle Iron Suspension for Injection in people with HNSCC and Soft Tissue Cancer, run by Sichuan Enray Pharmaceutical Sciences Company 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 17 inclusion and 21 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 24 Mar 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xiaohai Tang (+8613880881962, pharmmateceo@enraypharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) assessed according to RECIST 1.1 criteria (time frame: From date ofrandomization , assessed up to 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2026.