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New treatment option for Nasopharyngeal Carcinoma
Official title GAPP Induction and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance for Nasopharyngeal Carcinoma.
ClinicalTrials.gov ID: NCT06851247
What this study is testing
What is Toripalimab?
Toripalimab is an investigational medicine, given as an 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
- In order to explore the efficacy and safety of targeted therapy and immunotherapy combined with GP chemotherapy in the treatment of high risk advanced nasopharyngeal carcinoma, the investigators design a single-arm, Phase II clinical trial targeted high-risk patients with local stage nasopharyngeal carcinoma (stage IVa: TanyN3M0/T4N0-2M0,8th AJCC/UICC staging) for Toripalimab Plus Anlotinib Combined With GP Induction Chemotherapy and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance Therapy.
- 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 65
You may be able to join if
- Voluntarily participate in and sign informed consent in person.
- Age 18-65, male or non-pregnant female.
- Pathological diagnosis of nasopharyngeal non-keratonic carcinoma (differentiated or undifferentiated, i.e., WHO type II or III).
- First treatment patients who did not receive antitumor therapy had no history of other malignant tumors;
- Stage IVa: TanyN3M0/T4N0-2M0 (8th AJCC/UICC stage)
You likely can't join if
- Patients with recurrent and distant metastasis of nasopharyngeal carcinoma.
- The pathology was keratinized squamous cell carcinoma (WHO type I).
- Received systemic or local glucocorticoid therapy within 4 weeks prior to enrollment.
- Participants who had participated in other drug clinical trials within 3 months before treatment.
- Patients with a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Patients with idiopathic pulmonary fibrosis, drug-induced pneumonia, institutional pneumonia (i.e., bronchiolitis obliterans), radiation pneumonia...
See the full eligibility criteria
- Voluntarily participate in and sign informed consent in person.
- Age 18-65, male or non-pregnant female.
- Pathological diagnosis of nasopharyngeal non-keratonic carcinoma (differentiated or undifferentiated, i.e., WHO type II or III).
- First treatment patients who did not receive antitumor therapy had no history of other malignant tumors;
- Stage IVa: TanyN3M0/T4N0-2M0 (8th AJCC/UICC stage)
- ECOG score 0-1, no serious dysfunction of heart, lung, liver, kidney and other vital organs.
- Hemoglobin (HGB) ≥90 g/L, white blood cells (WBC) ≥4.0×109 /L, platelets (PLT) ≥100×109 /L.
- Liver function: ALT and AST\< 2.5 times the upper limit of normal (ULN), total bilirubin \<2.0×ULN.
- Renal function: serum creatinine \<1.5×ULN.
- Patients with recurrent and distant metastasis of nasopharyngeal carcinoma.
- The pathology was keratinized squamous cell carcinoma (WHO type I).
- Received systemic or local glucocorticoid therapy within 4 weeks prior to enrollment.
- Participants who had participated in other drug clinical trials within 3 months before treatment.
- Patients with a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Patients with idiopathic pulmonary fibrosis, drug-induced pneumonia, institutional pneumonia (i.e., bronchiolitis obliterans), radiation pneumonia with clinical symptoms or requiring steroid treatment, active pneumonia...
- Have a comorbiditis that requires long-term treatment with immunosuppressive drugs or systemic or local use of immunosuppressive doses of corticosteroids.
- Prior use of anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4 antibodies (or any other antibody that acts on the T-cell co-stimulation or checkpoint pathway), and how well it works was...
- The subject has any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism...
- Positive HBV DNA copy number was detected in HIV-positive patients and HBsAg positive patients (quantitative detection ≥ 1000cps/ml); Chronic hepatitis C blood screening positive (HCV antibody positive) with HCV RNA...
- Received any anti-infection vaccine (such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment.
- Pregnancy test positive women of childbearing age and breastfeeding women.
- Patients who are unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, 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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, 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.