Toripalimab with Platinum-Based Chemo for Nasopharyngeal Cancer
Toripalimab Combined With Different Platinum-Based Induction Chemotherapy Regimens for Locally Advanced Nasopharyngeal Carcinoma
Recruiting
Phase 2Interventional Study
Nasopharyngeal Cancinoma (NPC)
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 – 70
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
243 (estimated)
Sponsor
Sun Yat-sen University · Other
Who this trial is looking for
This trial is looking for adults with nasopharyngeal cancer who want to explore a new treatment option. Participants will receive Toripalimab along with different chemotherapy regimens followed by standard treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 70 years old
I have been diagnosed with nasopharyngeal carcinoma
My cancer has not spread to other parts of my body
I have a good performance status (ECOG 0 or 1)
My blood tests show adequate hematological, hepatic, and renal function
You may not be able to join if
I have nasopharyngeal cancer that has recurred or spread
I have a history of keratinizing squamous cell carcinoma
I have had prior chemotherapy or radiotherapy
I am pregnant, breastfeeding, or not using effective contraception
I have a history of other cancers (except for basal cell carcinoma)
I have received treatment with immune checkpoint inhibitors before
I have any severe medical condition that affects my health
I have active tuberculosis
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.
This phase II randomized trial compares the efficacy and safety of Toripalimab combined with three different platinum-based induction chemotherapy regimens, sequentially followed by standard concurrent chemoradiotherapy, for the treatment of locally advanced nasopharyngeal carcinoma (NPC). The study is aimed to pick up the most effective platinum-based induction chemotherapy regimen plus Toripalim…
This phase II randomized trial compares the efficacy and safety of Toripalimab combined with three different platinum-based induction chemotherapy regimens, sequentially followed by standard concurrent chemoradiotherapy, for the treatment of locally advanced nasopharyngeal carcinoma (NPC). The study is aimed to pick up the most effective platinum-based induction chemotherapy regimen plus Toripalimab for these patients which provides the most survival benefit.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age between 18 and 70 years, male or non-pregnant female.
2. Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
3. Stage Any T, N2-3 or T4, N1 (AJCC 9th edition staging), with no distant…
Inclusion Criteria:
1. Age between 18 and 70 years, male or non-pregnant female.
2. Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
3. Stage Any T, N2-3 or T4, N1 (AJCC 9th edition staging), with no distant metastasis (M0).
4. ECOG performance status score of 0 or 1.
5. Adequate hematological function: Hemoglobin (HGB)≥90g/L, Absolute Neutrophil Count (ANC) ≥ 1.5\*10\^9/L, and Platele (PLT) ≥100\*10\^9/L.
6. Adequate hepatic function: ALT and AST≤2.5\*Upper Limit of Normal (ULN), total bilirubin ≤2.0\*ULN, and serum albumin≥30g/L.
7. Adequate renal function: Serum creatinine ≤ 1.5\*ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula).
8. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 \*ULN (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected therapeutic range for the anticoagulant at the time of screening).
Exclusion Criteria:
1. Patients with nasopharyngeal carcinoma presenting with recurrence or distant metastasis.
2. Pathologically confirmed diagnosis of keratinizing squamous cell carcinoma (WHO Type I).
3. Prior history of radiotherapy or systemic chemotherapy.
4. Women who are pregnant, lactating, or of childbearing potential not employing effective contraception.
5. HIV-positive status.
6. History of other malignancies (except for cured basal cell carcinoma or carcinoma in situ of the cervix).
7. Patients previously treated with immune checkpoint inhibitors (e.g., CTLA-4, PD-1, PD-L1 inhibitors).
8. Patients with immunodeficiency diseases or a history of organ transplantation.
9. Patients who have received high-dose glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressive therapy within 4 weeks prior.
10. Patients with significantly impaired cardiac, hepatic, pulmonary, renal, or bone marrow function.
11. Concurrent use of other investigational drugs or current participation in another clinical trial.
12. Patients who refuse or are unable to provide signed informed consent for trial participation.
13. Patients with personality or psychiatric disorders, or those lacking legal capacity or with limited legal capacity.
14. Hepatitis B surface antigen (HBsAg) positive with peripheral blood Hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 1000 copies/ml.
15. Patients with positive Hepatitis C virus (HCV) antibody test results are eligible only if the HCV ribonucleic acid (RNA) polymerase chain reaction test result is negative.
16. Arterial or venous thrombotic events within 6 months prior to screening initiation, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.
17. Known history of active tuberculosis (TB). Subjects suspected of having active TB must be evaluated and ruled out via chest X-ray, sputum examination, and clinical signs and symptoms.
21.Any other severe, uncontrolled medical condition, infection, or treatment contraindication, or any other condition that, in the investigator's judgment, may pose a risk for receiving the investigational drug, or may interfere with the assessment of the investigational drug, subject safety, or interpretation of the study results.
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