Actively Recruiting
A Study of Nimotuzumab Plus Adebrelimab With Chemotherapy in Cisplatin-Ineligible Patients With Head And Neck Squamous Cell Carcinoma
Led by Fudan University · Updated on 2025-08-06
68
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Nimotuzumab Plus Adebrelimab With Chemotherapy in Cisplatin-Ineligible Patients With Head And Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma
- Cancer not curable by local treatments or patient unsuitable/refuses local treatment
- No prior systemic treatment after recurrence or metastasis
- Intolerance to cisplatin-based chemotherapy due to age over 70, ECOG PS score of 2, renal impairment, severe hearing loss, cardiac dysfunction, or patient refusal
- Tumor tissue available for P16/HPV testing if oropharyngeal cancer
- ECOG Performance Status score of 0 to 2
- At least one measurable lesion according to RECIST version 1.1
- Adequate organ function including blood counts, kidney, liver, and coagulation parameters
- Tumor tissue available for PD-L1 testing
- Negative pregnancy test for females before treatment and agreement to use effective contraception during the study and for 6 months after
- Ability to provide written informed consent and comply with study visits and procedures
You will not qualify if you...
- Disease curable by local treatment unless patient refuses or is unsuitable
- Radiotherapy or local treatment within 2 weeks prior to enrollment or unresolved adverse events from prior treatments (except mild neuropathy or alopecia)
- Participation in another clinical trial within 4 weeks before enrollment (except follow-up without treatment)
- Life expectancy less than 3 months or rapidly progressing disease with complications
- Immunodeficiency or use of systemic immunosuppressive treatment within 7 days prior to enrollment (with some exceptions)
- Other malignancies within 5 years except certain cured skin and cervical cancers
- Active central nervous system metastases unless stable for at least 4 weeks
- Active autoimmune disease requiring systemic treatment within 2 years prior to enrollment (with exceptions)
- History of organ or tissue transplantation
- History or current non-infectious pneumonitis requiring corticosteroids
- Active infection requiring systemic treatment
- Medical conditions that may affect safety or study assessments as judged by investigator
- Psychiatric disorders or substance abuse affecting study compliance
- Pregnancy, breastfeeding, or plans to conceive during screening and up to 180 days after last study drug dose
- Positive HIV infection or history
- Active hepatitis B or C infection
- Receipt of live vaccine within 30 days prior to study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
D
Dongmei Ji, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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