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New treatment option for Nasopharyngeal Carcinoma
Official title Anti-PD1 Monoclonal Antibody Combined With Nimotuzumab and Capecitabine in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT06259721
What this study is testing
What is Anti-PD1 antibody, nimotuzumab and capecitabine?
Anti-PD1 antibody, nimotuzumab and capecitabine is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for nasopharyngeal carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to explore the efficacy and safety of a combination regimen of Anti-PD1 monoclonal antibody, nimotuzumab, and capecitabin in treating recurrent or metastatic nasopharyngeal carcinoma patients who have failed first-line platinum-based chemotherapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Histologically or cytologically confirmed with recurrent or metastatic nasopharyngeal carcinoma which is not amenable to curative treatment with...
- Have failed for first-line platinum-based chemotherapy. Previously received first-line platinum-based chemotherapy for recurrent or metastatic...
- Age ≥ 18 years and ≤ 75 years, both genders.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- The life expectancy of at least 3 months.
You likely can't join if
- 1\. Those with a history of severe immediate allergy to any drugs used in this study; 2. Patients who have previously received anti-EGFR monoclonal...
- Controlled type 1 diabetes
- Hypothyroidism (if it can be controlled with hormone replacement therapy alone)
- Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia)
- Any other disease that is not expected to recur in the absence of external triggers 7. Active infections, including tuberculosis, hepatitis B...
See the full eligibility criteria
- Histologically or cytologically confirmed with recurrent or metastatic nasopharyngeal carcinoma which is not amenable to curative treatment with surgery and/or radiation therapy. If the patient refuses biopsy of...
- Have failed for first-line platinum-based chemotherapy. Previously received first-line platinum-based chemotherapy for recurrent or metastatic disease and had disease progression during or after treatment; or recurrence...
- Age ≥ 18 years and ≤ 75 years, both genders.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- The life expectancy of at least 3 months.
- Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria.
- Patients must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment) as determined by: Absolute neutrophil count (ANC) ≥1.5×109/L...
- All women with fertility potential must undergo a urine or serum pregnancy test during screening and the results are negative.
- Written informed consent.
- 1\. Those with a history of severe immediate allergy to any drugs used in this study; 2. Patients who have previously received anti-EGFR monoclonal antibodies (nitolizumab, cetuximab) and anti-PD-1 monoclonal...
- Controlled type 1 diabetes
- Hypothyroidism (if it can be controlled with hormone replacement therapy alone)
- Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia)
- Any other disease that is not expected to recur in the absence of external triggers 7. Active infections, including tuberculosis, hepatitis B, hepatitis C and human immunodeficiency virus. Patients with positive HBV...
The study team makes the final eligibility decision.
Where it's taking place
- Nanchang, Jiangxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanchang, Jiangxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.