Head and Neck Squamous Cell CarcinomaPhase 1/2NCT07105592
A Study of Nimotuzumab Plus Adebrelimab With Chemotherapy in Cisplatin-Ineligible Patients With Head And Neck Squamous Cell Carcinoma
A Phase 1/2 study testing Nimotuzumab+Adebrelimab+Chemotherapy in people with Head and Neck Squamous Cell Carcinoma, run by Fudan University at 1 site in China.
Trial summary
This is a prospective, single-arm, Phase Ib/II clinical study to evaluate the safety and efficacy of nimotuzumab combined with adebrelimab and chemotherapy in patients with recurrent and metastatic head and neck squamous cell carcinoma who are ineligible to high-dose cisplatin treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Nimotuzumab+Adebrelimab+Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2025to 31 May 2029
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥18 years.
- Diagnosis: Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma, meeting the following conditions:Local treatment methods cannot achieve a cure (including cases where the patient refuses local treatment or is deemed unsuitable for local treatment by the physician, e.g., inability to tolerate anesthesia or other factors precluding local radiotherapy).No prior systemic treatment (targeted therapy, immunotherapy, and/or chemotherapy) after recurrence or metastasis.Primary nasopharyngeal carcinoma is not permitted.
- Cisplatin Intolerance: Patients must have at least one of the following reasons for being unsuitable for cisplatin-based chemotherapy:Age >70 years.Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 2.Renal function impairment (creatinine clearance <50 mL/min). If this criterion is met, the creatinine clearance standard in criterion 7 is not applicable.Severe tinnitus or hearing loss (requiring a hearing aid or showing a ≥25 dB shift at two consecutive frequencies on audiometry).Inability to receive intravenous hydration due to cardiac dysfunction or other comorbidities (left ventricular ejection fraction [LVEF] <50%).Patient refusal of cisplatin-based chemotherapy.
- Oropharyngeal Cancer: Availability of tumor tissue for P16/HPV testing (if previously tested, retesting is not required).
- Performance Status: ECOG PS score of 0-2.
- Measurable Disease: At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
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- Adequate organ function：Hematology:Absolute Neutrophil Count (ANC): ≥1500/μL (1.5 × 10⁹/L),Platelets: ≥100,000/μL (100 × 10⁹/L),Hemoglobin: ≥9 g/dL (90 g/L) or ≥5.6 mmol/L.Renal:Serum Creatinine or Creatinine Clearance: Creatinine ≤1.5 × Upper Limit of Normal (ULN); if creatinine >1.5 × ULN, then creatinine clearance must be ≥60 mL/min.Hepatic:Total Bilirubin: ≤1.5 × ULN,Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT): ≤2.5 × ULN; if liver metastases are present, then ≤5 × ULN.Coagulation:International Normalized Ratio (INR) or Prothrombin Time (PT): ≤1.5 × ULN; if the patient is receiving anticoagulant therapy, PT or Partial Thromboplastin Time (PTT) must be within the therapeutic range for the anticoagulant used.
- PD-L1 Testing: Availability of tumor tissue (from the tumor core or resected tumor) for PD-L1 testing (if previously tested, additional testing is not required).
- Reproductive Status:Female subjects must have a negative pregnancy test within two weeks before starting study treatment and must not be breastfeeding.Female subjects must agree to use effective contraception during the study and for 6 months after the last dose of study drug.Male subjects must agree to use effective contraception during the study and for 6 months after the last dose of study drug.
- Informed Consent: Subjects must voluntarily participate in the study, provide written informed consent, and be able to comply with the protocol-specified visits and procedures.
Who cannot join
- Curable by Local Treatment: Patients whose disease can be cured by local treatment methods. Exceptions include cases where the patient refuses local treatment or is deemed unsuitable for local treatment by the investigator (specific reasons must be documented at enrollment).
- Recent Local Treatment or Unresolved Adverse Events: Patients who have undergone radiotherapy or other local treatments (e.g., surgery) within 2 weeks prior to enrollment, or who have not recovered from adverse events (AEs) from prior treatments (i.e., AEs ≤ Grade 1 or returned to baseline). Exceptions include:Peripheral neuropathy ≤ Grade 2. Alopecia ≤ Grade 2.Laboratory abnormalities meeting inclusion criterion 7 (adequate organ function).
- Recent Clinical Trial Participation: Patients who participated in another clinical trial within 4 weeks prior to enrollment (except those in the follow-up period who did not receive treatment).
- Poor Prognosis: Patients with an estimated life expectancy of less than 3 months as assessed by the investigator, or those with rapidly progressing disease (e.g., tumor bleeding or uncontrolled tumor pain).
- Immunosuppression: Patients diagnosed with an immunodeficiency disease within 7 days prior to enrollment, or those receiving systemic corticosteroid therapy or other immunosuppressive treatments. Exceptions include:Use of contrast agents.Corticosteroid use for managing AEs.Physiological doses of corticosteroids as determined by the investigator.
- Other Malignancies: Patients diagnosed with another malignant tumor within 5 years prior to enrollment. Exceptions include:Cured basal cell carcinoma of the skin.Cured squamous cell carcinoma of the skin.Cervical carcinoma in situ.Breast carcinoma in situ.Other cured tumors deemed acceptable by the investigator.
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- Active CNS Metastases: Patients with known active central nervous system (CNS) metastases. Exceptions include patients with stable CNS metastases for at least 4 weeks prior to enrollment (confirmed by stable CT or MRI, no new lesions, no progression of existing lesions, resolution of neurological symptoms to baseline, and no corticosteroid use for at least 7 days). Patients with carcinomatous meningitis, regardless of stability, are excluded.
- Active Autoimmune Disease: Patients with an active autoimmune disease requiring systemic treatment within 2 years prior to enrollment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants). Exceptions include replacement therapies (e.g., thyroxine, insulin, or physiological doses of corticosteroids for adrenal or pituitary insufficiency).
- Organ or Tissue Transplantation: Patients who have received allogeneic tissue or solid organ transplantation.
- Non-Infectious Pneumonitis: Patients with a history of non-infectious pneumonitis requiring corticosteroid treatment or current pneumonitis.
- Active Infection: Patients with an active infection requiring systemic treatment.
- Other Safety Concerns: Patients with medical conditions or histories that, in the investigator's judgment, may compromise safety or interfere with study assessments.
- Mental Health or Substance Abuse: Patients with psychiatric disorders or substance abuse issues that may affect study compliance or cooperation.
- Pregnancy or Reproductive Plans: Pregnant or breastfeeding women, or individuals planning to conceive from the start of the screening period until 180 days after the last dose of study drug.
- HIV Infection: Patients with positive HIV serology or a history of HIV infection.
- Active Hepatitis: Patients with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Recent Live Vaccine: Patients who received a live vaccine within 30 days prior to the start of the study.
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, 1 recruiting
- Recruiting
Fudan University
Shanghai, Shanghai Municipality
Dongmei Ji, doctor, 13564183928, jidongmei2000@126.com
Dongmei Ji, doctor
About this study
Official title: A Prospective, Phase Ib/II Study of Nimotuzumab Combined With Adebrelimab and Chemotherapy for the Treatment of Patients With Recurrent/Metastatic Head And Neck Squamous Cell Carcinoma Who Are Ineligible to High-Dose Cisplatin
This is a prospective, single-arm, Phase Ib/II clinical study to evaluate the safety and efficacy of nimotuzumab combined with adebrelimab and chemotherapy in patients with recurrent and metastatic head and neck squamous cell carcinoma who are ineligible to high-dose cisplatin treatment.
Read the detailed description
This study is a prospective, single-arm, Phase Ib/II clinical trial. Phase Ib uses a 3+3 dose escalation design, and Phase II uses a Simon two-stage design. Phase Ib explores the proper dosage of nimotuzumab to combine with adebrelimab and chemotherapy in patients with recurrent and metastatic head and neck squamous cell carcinoma who are ineligible to high-dose cisplatin treatment. Phase II explores the efficacy and safety of nimotuzumab combined with adebrelimab and chemotherapy in the same patient population. It is expected to enroll approximately 68 subjects with recurrent and metastatic head and neck squamous cell carcinoma who are ineligible to high-dose cisplatin treatment.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Nimotuzumab+Adebrelimab+Chemotherapy
- Keywords
- PD-L1 inhibitor, Nimotuzumab, Adebrelimab, Cisplatin intolerance, EGFR inhibitor
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nimotuzumab+Adebrelimab+ChemotherapyDrug
Phase Ib Treatment Regimen:
Nimotuzumab: Three dose groups (200 mg, 400 mg, 600 mg), administered via intravenous infusion over at least 60 minutes, once every 3 weeks, until disease progression, intolerable toxicity, or subject withdrawal from the trial.
Adebrelimab: Fixed dose of 1200 mg, administered via intravenous infusion, once every 3 weeks, until disease progression, intolerable toxicity, or subject withdrawal from the trial.
Albumin-bound Paclitaxel: 100 mg/m², administered intravenously on Days 1 and 8, once every 3 weeks, for 6 cycles.
Carboplatin: AUC=2 (calculated using the Calvert formula), administered intravenously on Days 1 and 8, once every 3 weeks, for 6 cycles.
Phase II Treatment Regimen:
Nimotuzumab: Recommended Phase II dose (RP2D) as determined from Phase Ib, administered via intravenous infusion on Day 1, once every 3 weeks, until disease progression, intolerable toxicity, or subject withdrawal from the trial.
Adebrelimab: Fixed dose of 1200 mg, administered via
| Study group | Role | What they receive |
|---|---|---|
| Nimotuzumab+Adebrelimab+Chemotherapy | Experimental | Phase Ib Treatment Regimen:
Nimotuzumab: Three dose groups (200 mg, 400 mg, 600 mg), administered via intravenous infusion over at least 60 minutes, once every 3 weeks, until disease progression, intolerable toxicity, or subject withdrawal from the trial.
Adebrelimab: Fixed dose of 1200 mg, administered via intravenous infusion, once every 3 weeks, until disease progression, intolerable toxicity, or subject withdrawal from the trial.
Albumin-bound Paclitaxel: 100 mg/m², administered intravenously on Days 1 and 8, once every 3 weeks, for 6 cycles.
Carboplatin: AUC=2 (calculated using the Calvert formula), administered intravenously on Days 1 and 8, once every 3 weeks, for 6 cycles.
Phase II Treatment Regimen:
Nimotuzumab: Recommended Phase II dose (RP2D) as determined from Phase Ib, administered via intravenous infusion on Day 1, once every 3 weeks, until disease progression, intolerable toxicity, or subject withdrawal from the trial.
Adebrelimab: Fixed dose of 1200 mg, administered vi Receives: Drug: Nimotuzumab+Adebrelimab+Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib:Dose-limiting toxicity (DLT)
Occurrence of specific severe toxicities (grade 3 or 4) related to the treatment during the first cycle.
Measured: 3 weeks after treatment initiation
Phase II:Objective response rate (ORR)
Objective response rate measured as number of complete and partial response divided by the number of patients included.
Measured: 2 years after enrollment of final patient
Secondary outcomes (8)
Phase Ib:Objective response rate (ORR)
Objective response rate measured as number of complete and partial response divided by the number of patients included.
Measured: 2 years after enrollment of final patient
Phase Ib/Phase II::Disease control rate (DCR)
Disease control rate measured as number of complete and partial response or stable disease divided by the number of patients included.
Measured: 2 years after enrollment of final patient
Phase Ib/Phase II:Progression-free Survival (PFS)
Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: up to 2 years
Phase Ib/Phase II:Overall Survival (OS)
Overall Survival (OS) (median) was determined using the number of months measured from the initial date of treatment to the recorded date of death of participants.
Measured: up to 2 years
Phase II:Safety
Incidence of Treatment-Emergent Adverse Events (CTCAE 5.0）
Measured: Since the signing of informed consent forms to 30 days after the last cycle
Phase II:Quality of life
Assessed using EORTC QLQ-C30 (V3) questionnaires.The EORTC QLQ-C30 is a 30-item validated questionnaire designed to assess the quality of life in cancer patients. It includes five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea/vomiting), a global health status/quality of life scale, and six single items assessing additional symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All scales and single items are scored on a range from 0 to 100. For the functional scales and global health status scale, higher scores indicate better quality of life or functioning. For the symptom scales and single items, higher scores indicate worse symptoms or greater severity.
Measured: up to 2 years
Phase II:Quality of life
Assessed using EORTC QLQ-H\&N35 questionnaires.The EORTC QLQ-H\&N35 is a 35-item validated questionnaire specifically designed to assess quality of life in head and neck cancer patients. It includes seven symptom scales (pain, swallowing, senses, speech, social eating, social contact, and sexuality) and eleven single items addressing additional head and neck-specific symptoms (e.g., teeth problems, mouth opening, dry mouth, sticky saliva, coughing, feeling ill, use of painkillers, nutritional supplements, feeding tube, weight loss, and weight gain). All scales and single items are scored on a range from 0 to 100, with higher scores indicating worse symptoms or greater severity.
Measured: up to 2 years
Phase II:Impact of tumor-related biomarkers on prognosis
Analysis of how specific biomarkers correlate with patient outcomes.
Measured: 2 years after enrollment of final patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start13 May 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Dongmei, Fudan University
- Investigators
- Dongmei Ji, doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105592
- Sponsor's protocol ID
- FUSCC-HN-002
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 6 Aug 2025
- 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 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Phase Ib/II Study of Nimotuzumab Combined With Adebrelimab and Chemotherapy for the Treatment of Patients With Recurrent/Metastatic Head And Neck Squamous Cell Carcinoma Who Are Ineligible to High-Dose Cisplatin
- ClinicalTrials.gov ID
- NCT07105592
- Acronym / sponsor ID
- FUSCC-HN-002
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- PD-L1 inhibitor, Nimotuzumab, Adebrelimab, Cisplatin intolerance, EGFR inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 6 Aug 2025 (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.
This is a prospective, single-arm, Phase Ib/II clinical study to evaluate the safety and efficacy of nimotuzumab combined with adebrelimab and chemotherapy in patients with recurrent and metastatic head and neck squamous cell carcinoma who are ineligible to high-dose cisplatin treatment.
Detailed description
This study is a prospective, single-arm, Phase Ib/II clinical trial. Phase Ib uses a 3+3 dose escalation design, and Phase II uses a Simon two-stage design. Phase Ib explores the proper dosage of nimotuzumab to combine with adebrelimab and chemotherapy in patients with recurrent and metastatic head and neck squamous cell carcinoma who are ineligible to high-dose cisplatin treatment. Phase II explores the efficacy and safety of nimotuzumab combined with adebrelimab and chemotherapy in the same patient population. It is expected to enroll approximately 68 subjects with recurrent and metastatic head and neck squamous cell carcinoma who are ineligible to high-dose cisplatin treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab+Adebrelimab+Chemotherapy | Experimental | Drug: Nimotuzumab+Adebrelimab+ChemotherapyPhase Ib Treatment Regimen: Nimotuzumab: Three dose groups (200 mg, 400 mg, 600 mg), administered via intravenous infusion over at least 60 minutes, once every 3 weeks, until disease progression, intolerable toxicity, or subject withdrawal from the trial. Adebrelimab: Fixed dose of 1200 mg, administered via intravenous infusion, once every 3 weeks, until disease progression, intolerable toxicity, or subject withdrawal from the trial. Albumin-bound Paclitaxel: 100 mg/m², administered intravenously on Days 1 and 8, once every 3 weeks, for 6 cycles. Carboplatin: AUC=2 (calculated using the Calvert formula), administered intravenously on Days 1 and 8, once every 3 weeks, for 6 cycles. Phase II Treatment Regimen: Nimotuzumab: Recommended Phase II dose (RP2D) as determined from Phase Ib, administered via intravenous infusion on Day 1, once every 3 weeks, until disease progression, intolerable toxicity, or subject withdrawal from the trial. Adebrelimab: Fixed dose of 1200 mg, administered vi |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: ≥18 years.
- Diagnosis: Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma, meeting the following conditions:Local treatment methods cannot achieve a cure (including cases where the patient refuses local treatment or is deemed unsuitable for local treatment by the physician, e.g., inability to tolerate anesthesia or other factors precluding local radiotherapy).No prior systemic treatment (targeted therapy, immunotherapy, and/or chemotherapy) after recurrence or metastasis.Primary nasopharyngeal carcinoma is not permitted.
- Cisplatin Intolerance: Patients must have at least one of the following reasons for being unsuitable for cisplatin-based chemotherapy:Age >70 years.Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 2.Renal function impairment (creatinine clearance <50 mL/min). If this criterion is met, the creatinine clearance standard in criterion 7 is not applicable.Severe tinnitus or hearing loss (requiring a hearing aid or showing a ≥25 dB shift at two consecutive frequencies on audiometry).Inability to receive intravenous hydration due to cardiac dysfunction or other comorbidities (left ventricular ejection fraction [LVEF] <50%).Patient refusal of cisplatin-based chemotherapy.
- Oropharyngeal Cancer: Availability of tumor tissue for P16/HPV testing (if previously tested, retesting is not required).
- Performance Status: ECOG PS score of 0-2.
Key exclusion criteria (17 listed)
- Curable by Local Treatment: Patients whose disease can be cured by local treatment methods. Exceptions include cases where the patient refuses local treatment or is deemed unsuitable for local treatment by the investigator (specific reasons must be documented at enrollment).
- Recent Local Treatment or Unresolved Adverse Events: Patients who have undergone radiotherapy or other local treatments (e.g., surgery) within 2 weeks prior to enrollment, or who have not recovered from adverse events (AEs) from prior treatments (i.e., AEs ≤ Grade 1 or returned to baseline). Exceptions include:Peripheral neuropathy ≤ Grade 2. Alopecia ≤ Grade 2.Laboratory abnormalities meeting inclusion criterion 7 (adequate organ function).
- Recent Clinical Trial Participation: Patients who participated in another clinical trial within 4 weeks prior to enrollment (except those in the follow-up period who did not receive treatment).
- Poor Prognosis: Patients with an estimated life expectancy of less than 3 months as assessed by the investigator, or those with rapidly progressing disease (e.g., tumor bleeding or uncontrolled tumor pain).
- Immunosuppression: Patients diagnosed with an immunodeficiency disease within 7 days prior to enrollment, or those receiving systemic corticosteroid therapy or other immunosuppressive treatments. Exceptions include:Use of contrast agents.Corticosteroid use for managing AEs.Physiological doses of corticosteroids as determined by the investigator.
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 |
|---|---|---|
| Nimotuzumab+Adebrelimab+ChemotherapyPhase Ib Treatment Regimen: Nimotuzumab: Three dose groups (200 mg, 400 mg, 600 mg), administered via intravenous infusion over at least 60 minutes, once every 3 weeks, until disease progression, intolerable toxicity, or subject withdrawal from the trial. Adebrelimab: Fixed dose of 1200 mg, administered via intravenous infusion, once every 3 weeks, until disease progression, intolerable toxicity, or subject withdrawal from the trial. Albumin-bound Paclitaxel: 100 mg/m², administered intravenously on Days 1 and 8, once every 3 weeks, for 6 cycles. Carboplatin: AUC=2 (calculated using the Calvert formula), administered intravenously on Days 1 and 8, once every 3 weeks, for 6 cycles. Phase II Treatment Regimen: Nimotuzumab: Recommended Phase II dose (RP2D) as determined from Phase Ib, administered via intravenous infusion on Day 1, once every 3 weeks, until disease progression, intolerable toxicity, or subject withdrawal from the trial. Adebrelimab: Fixed dose of 1200 mg, administered via | Drug | Nimotuzumab+Adebrelimab+Chemotherapy |
Primary outcome
Phase Ib:Dose-limiting toxicity (DLT)
Time frame: 3 weeks after treatment initiation
Occurrence of specific severe toxicities (grade 3 or 4) related to the treatment during the first cycle.
Phase II:Objective response rate (ORR)
Time frame: 2 years after enrollment of final patient
Objective response rate measured as number of complete and partial response divided by the number of patients included.
8 secondary outcomes
Phase Ib:Objective response rate (ORR)
Time frame: 2 years after enrollment of final patient
Phase Ib/Phase II::Disease control rate (DCR)
Time frame: 2 years after enrollment of final patient
Phase Ib/Phase II:Progression-free Survival (PFS)
Time frame: up to 2 years
Phase Ib/Phase II:Overall Survival (OS)
Time frame: up to 2 years
Phase II:Safety
Time frame: Since the signing of informed consent forms to 30 days after the last cycle
Phase II:Quality of life
Time frame: up to 2 years
Phase II:Quality of life
Time frame: up to 2 years
Phase II:Impact of tumor-related biomarkers on prognosis
Time frame: 2 years after enrollment of final patient
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 6 Aug 2025.
- 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.
Dongmei Ji, doctor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nimotuzumab+Adebrelimab+Chemotherapy in people with Head and Neck Squamous Cell Carcinoma, run by Fudan 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 10 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: looking for participants now, as of the sponsor's last update on 6 Aug 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 combined 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.
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 Dongmei Ji, doctor (13564183928, jidongmei2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib:Dose-limiting toxicity (DLT) (time frame: 3 weeks after treatment initiation). 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?
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 6 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.