Nimotuzumab with toripalimab plus gemcitabine/cisplatin for first-line recurrent or metastatic nasopharyngeal carcinoma

Nimotuzumab Combined With Toripalimab/Gemcitabine/Cisplatin as First-line Therapy in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma: a Prospective, Single-arm, Phase II Clinical Study

This trial tests whether adding nimotuzumab to toripalimab with gemcitabine and cisplatin helps people with first-line recurrent or metastatic nasopharyngeal carcinoma.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, nimotuzumab, toripalimab
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06509009 on ClinicalTrials.gov

What this trial studies

This is a single-center, prospective, single-arm phase II trial enrolling patients with first-line recurrent or distant‑metastatic nasopharyngeal carcinoma. Participants receive three‑week cycles of gemcitabine and cisplatin for up to six cycles while nimotuzumab and toripalimab are continued until disease progression. Tumor responses will be measured using RECIST 1.1 and irRECIST, and adverse events will be graded with CTCAE v5.0. Efficacy and safety data will be collected at regular follow-up visits at the Cancer Hospital, Chinese Academy of Medical Sciences in Beijing.

Who should consider this trial

Good fit: Ideal candidates are adults (18–75) with EGFR‑positive, histologically confirmed first‑line recurrent or distant‑metastatic nasopharyngeal carcinoma, at least one measurable lesion, ECOG 0–2, and adequate organ and marrow function.

Not a fit: Patients who are EGFR‑negative, have poor performance status or significant organ dysfunction, or who cannot tolerate platinum‑based chemotherapy are unlikely to benefit from this regimen.

Why it matters

Potential benefit: If effective, this combination could increase tumor response rates and delay disease progression for patients with recurrent or metastatic nasopharyngeal carcinoma.

How similar studies have performed: PD‑1 inhibitors combined with gemcitabine/cisplatin have shown benefit in recurrent/metastatic nasopharyngeal carcinoma, but adding an anti‑EGFR antibody like nimotuzumab to this regimen is relatively novel with limited prior data.

Eligibility criteria

Inclusion Criteria:

Signed written informed consent form.

Age between 18 and 75 years, inclusive, without gender restriction.

Histologically confirmed diagnosis of recurrent/distant metastasis nasopharyngeal carcinoma, first line patients and unsuitable for local operation treatment.

EGFR expression positive.

Presence of at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and patients who have not undergone definitive treatment.

ECOG Performance Status (PS) score of 0 or 2.

Expected survival duration of at least 3 months.

White blood cell count ≥ 3 × 10\^9/L; absolute neutrophil count ≥ 1.5 × 10\^9/L; platelet count ≥ 100 × 10\^9/L; hemoglobin level ≥ 90 g/L.

Serum creatinine level ≤ 1.2 mmol/L or creatinine clearance ≥ 60 ml/min.

Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) (in case of liver metastasis, ≤ 3.0 × ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (in case of liver metastasis, ≤ 5.0 × ULN).

Female patients must have a negative urine pregnancy test prior to study enrollment (this criterion does not apply to patients with bilateral ovarian resection and/or hysterectomy or postmenopausal patients).

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Exclusion Criteria:

Subjects who have received radiotherapy, chemotherapy, immunosuppressive agents, monoclonal antibodies, oral epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), or anti-angiogenic drugs within the past six months.

Subjects who have participated in another interventional clinical trial, undergone major surgical procedures, or scheduled for surgery within 30 days prior to screening.

Patients with severe underlying diseases that preclude tolerance to the treatment.

History of other malignancies, except for cured cervical carcinoma in situ, skin basal cell carcinoma, or malignancies cured for more than 5 years without recurrence.

Presence of uncontrolled comorbidities such as heart failure, diabetes mellitus, hypertension, thyroid disorders, psychiatric illnesses, etc.

Subjects with contraindications to immunotherapy, including those with immune dysfunction diseases (such as rheumatoid arthritis, psoriasis, systemic lupus erythematosus, HIV infection, hepatitis B, hepatitis C, chronic use of steroids for autoimmune diseases), recipients of allogeneic transplants, patients with interstitial lung disease, or those with meningeal metastasis or progressive brain metastasis.

Allergy to any of the drugs or their components used in the study protocol. Grade 2 or higher peripheral neuropathy or hearing loss according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

Pregnant women (confirmed by blood or urine human chorionic gonadotropin \[HCG\] test) or lactating mothers, or subjects of reproductive age who are unwilling or unable to adopt effective contraceptive measures until at least 6 months after the last treatment in the study.

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Where this trial is running

Beijing, Beijing Municipality

• 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 (Recruiting)

Study contacts

• Principal investigator: He Xiaohui — Department of Medical Oncology
• Study coordinator: Yang Sheng

Conditions Nasopharyngeal Carcinoma by AJCC V8 Stage; nasopharyngeal carcinoma