Adebrelimab plus Chemotherapy for Nasopharyngeal Cancer
GP Plus Adebrelimab Versus GP Neoadjuvant Chemotherapy for Nasopharyngeal Carcinoma
Recruiting
Phase 2Interventional Study
Nasopharyngeal Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
216 (estimated)
Sponsor
Sun Yat-sen University · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 65 with a specific type of nasopharyngeal cancer. Participants will receive a combination treatment of chemotherapy and adebrelimab to see how well it works compared to chemotherapy alone.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 65 years old.
I have been diagnosed with nonkeratinizing nasopharyngeal carcinoma.
My cancer stage is T4N0-1M0 or T1-4N2-3M0.
I have not received any previous cancer treatments.
I have a good performance status with an ECOG score of 0 or 1.
My blood tests show normal levels of white blood cells, hemoglobin, and platelets.
My liver function tests are within normal limits.
I have adequate kidney function.
You may not be able to join if
I have recurrent or metastatic nasopharyngeal carcinoma.
I have keratinizing squamous cell carcinoma of the nasopharynx.
I have previously received radiation or chemotherapy.
I am pregnant, breastfeeding, or not using effective birth control.
I am HIV positive.
I have a history of other cancers, except for some specific conditions.
I have taken immune checkpoint inhibitors before.
I have severe issues with my heart, liver, lungs, kidneys, or bone marrow.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The purpose of this study is to explore the efficacy and safety of neoadjuvant GP chemotherapy plus adebrelimab versus neoadjuvant GP chemotherapy in treating high-risk locoregionally advanced nasopharyngeal carcinoma patients.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Patients must be informed of the investigational nature of this study and give written informed consent.
2. Age ≥ 18 years and ≤65 years, men or non-pregnant women.
3. Patients with histologically confirmed Nonkeratinizing carcinoma of the nasopharynx (differentiated or undif…
Inclusion Criteria:
1. Patients must be informed of the investigational nature of this study and give written informed consent.
2. Age ≥ 18 years and ≤65 years, men or non-pregnant women.
3. Patients with histologically confirmed Nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, WHO II or III).
4. Tumor staged as T4N0-1M0 or T1-4N2-3M0 (AJCC 8th).
5. No previous anti-tumor treatment.
6. Eastern Cooperative Oncology Group (ECOG) score 0 or 1.
7. Adequate marrow function: White blood cell count (WBC)≥4.0×109 /L, Hemoglobin ≥ 90g/L, Platelet count ≥100×109/L.
8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin (TBIL) ≤2×upper limit of normal (ULN).
9. Adequate renal function: creatinine clearance rate ≥ 60 ml/min or Creatinine ≤ 1.5× upper limit of normal value.
Exclusion Criteria:
1. Patients with recurrent or metastatic nasopharyngeal carcinoma.
2. Histologically confirmed with keratinizing squamous cell carcinoma of the nasopharynx.
3. Prior therapy with radiation or systemic chemotherapy.
4. Women in the period of pregnancy, lactation, or reproductive without effective contraceptive measures.
5. Seropositivity for human immunodeficiency virus (HIV).
6. Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix).
7. Prior exposure to immune checkpoint inhibitors,including anti-PD-1, anti- PD-L1, anti-CTLA-4 antibodies.
8. Patients with immunodeficiency disease or a history of organ transplantation.
9. Received large doses of glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressants within 4 weeks.
10. Patients with severe dysfunction of heart, liver, lung, kidney or marrow.
11. Patients with severe, uncontrolled disease or infections.
12. Received other research drugs or in other clinical trials at the same time.
13. Refuse or fail to sign the informed consent .
14. Patients with other treatment contraindications.
15. Patients with personality or mental disorders, incapacity or limited capacity for civil conduct.
16. Hepatitis B surface antigen (HBsAg) positive and peripheral blood HBV deoxyribonucleic acid (HBV DNA) ≥1000cps/ml or 200 IU/ml.
17. Patients with positive HCV antibody test will only be enrolled in this study if the PCR test for HCV RNA is negative.
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