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New treatment option for Nasopharyngeal Cancinoma (NPC)
Official title Toripalimab Combined With Different Platinum-Based Induction Chemotherapy Regimens for Locally Advanced Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT07362979
What this study is testing
What is GP plus Toripalimab Induction chemotherapy+CCRT?
GP plus Toripalimab Induction chemotherapy+CCRT is an investigational medicine, being studied as a potential treatment for nasopharyngeal cancinoma (npc).
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
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Age between 18 and 70 years, male or non-pregnant female.
- Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
- Stage Any T, N2-3 or T4, N1 (AJCC 9th edition staging), with no distant metastasis (M0).
- ECOG performance status score of 0 or 1.
- Adequate hematological function: Hemoglobin (HGB)≥90g/L, Absolute Neutrophil Count (ANC) ≥ 1.5\ 10\^9/L, and Platele (PLT) ≥100\ 10\^9/L.
You likely can't join if
- Patients with nasopharyngeal carcinoma presenting with recurrence or distant metastasis.
- Pathologically confirmed diagnosis of keratinizing squamous cell carcinoma (WHO Type I).
- Prior history of radiotherapy or systemic chemotherapy.
- Women who are pregnant, lactating, or of childbearing potential not employing effective contraception.
- HIV-positive status.
- History of other malignancies (except for cured basal cell carcinoma or carcinoma in situ of the cervix).
See the full eligibility criteria
- Age between 18 and 70 years, male or non-pregnant female.
- Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
- Stage Any T, N2-3 or T4, N1 (AJCC 9th edition staging), with no distant metastasis (M0).
- ECOG performance status score of 0 or 1.
- Adequate hematological function: Hemoglobin (HGB)≥90g/L, Absolute Neutrophil Count (ANC) ≥ 1.5\ 10\^9/L, and Platele (PLT) ≥100\ 10\^9/L.
- Adequate hepatic function: ALT and AST≤2.5\ Upper Limit of Normal (ULN), total bilirubin ≤2.0\ ULN, and serum albumin≥30g/L.
- Adequate renal function: Serum creatinine ≤ 1.5\ ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula).
- 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...
- Patients with nasopharyngeal carcinoma presenting with recurrence or distant metastasis.
- Pathologically confirmed diagnosis of keratinizing squamous cell carcinoma (WHO Type I).
- Prior history of radiotherapy or systemic chemotherapy.
- Women who are pregnant, lactating, or of childbearing potential not employing effective contraception.
- HIV-positive status.
- History of other malignancies (except for cured basal cell carcinoma or carcinoma in situ of the cervix).
- Patients previously treated with immune checkpoint inhibitors (e.g., CTLA-4, PD-1, PD-L1 inhibitors).
- Patients with immunodeficiency diseases or a history of organ transplantation.
- Patients who have received high-dose glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressive therapy within 4 weeks prior.
- Patients with significantly impaired cardiac, hepatic, pulmonary, renal, or bone marrow function.
- Concurrent use of other investigational drugs or current participation in another clinical trial.
- Patients who refuse or are unable to provide signed informed consent for trial participation.
- Patients with personality or psychiatric disorders, or those lacking legal capacity or with limited legal capacity.
- Hepatitis B surface antigen (HBsAg) positive with peripheral blood Hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 1000 copies/ml.
- 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.
- 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...
- Known history of active tuberculosis (TB). people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Dongguan, Guangdong, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Zhanjiang, Guangdong, 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 Dongguan, Guangdong, China; Guangzhou, Guangdong, China; Shenzhen, Guangdong, China; Zhanjiang, Guangdong, 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.