Actively Recruiting
Nimotuzumab Combined With TGP as First-line Therapy in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-09-19
30
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to learn the efficacy and safety of nimotuzumab combined with toripalimab and gemcitabine/cisplatin regimen treatment recurrent/distant-metastasis nasopharyngeal carcinoma.
CONDITIONS
Official Title
Nimotuzumab Combined With TGP as First-line Therapy in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent form.
- Age between 18 and 75 years, inclusive.
- Histologically confirmed recurrent or distant metastatic nasopharyngeal carcinoma.
- First-line treatment patients unsuitable for local surgery.
- Positive EGFR expression.
- At least one measurable lesion by RECIST 1.1 and no prior definitive treatment.
- ECOG Performance Status score of 0 to 2.
- Expected survival of at least 3 months.
- Adequate blood counts: WBC ≥ 3 x 10^9/L; neutrophils ≥ 1.5 x 10^9/L; platelets ≥ 100 x 10^9/L; hemoglobin ≥ 90 g/L.
- Serum creatinine ≤ 1.2 mmol/L or creatinine clearance ≥ 60 ml/min.
- Liver function within specified limits: bilirubin ≤ 1.5 x ULN (up to 3.0 x ULN if liver metastasis); AST and ALT ≤ 2.5 x ULN (up to 5.0 x ULN if liver metastasis).
- Negative urine pregnancy test for women unless postmenopausal or having had bilateral oophorectomy/hysterectomy.
You will not qualify if you...
- Received radiotherapy, chemotherapy, immunosuppressants, monoclonal antibodies, oral EGFR-TKIs, or anti-angiogenic drugs within 6 months.
- Participated in another interventional clinical trial, had major surgery, or scheduled surgery within 30 days before screening.
- Severe underlying diseases preventing treatment tolerance.
- History of other malignancies except cured cervical carcinoma in situ, skin basal cell carcinoma, or cancers cured over 5 years without recurrence.
- Uncontrolled comorbidities like heart failure, diabetes, hypertension, thyroid disorders, psychiatric illnesses.
- Contraindications to immunotherapy including immune dysfunction diseases, allogeneic transplant recipients, interstitial lung disease, meningeal or progressive brain metastasis.
- Allergy to study drugs or components.
- Grade 2 or higher peripheral neuropathy or hearing loss per NCI CTCAE 5.0.
- Pregnant or breastfeeding women, or reproductive-age subjects unwilling or unable to use effective contraception for at least 6 months after last treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medcial Science and Peking Union Medical College
Beijing, Beijing Municipality, China, 1000000
Actively Recruiting
Research Team
Y
Yang Sheng
CONTACT
H
He Xiaohui
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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