Actively Recruiting
GAPP Induction and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance for Nasopharyngeal Carcinoma.
Led by Sun Yat-sen University · Updated on 2025-02-28
47
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GAPP Induction and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance for Nasopharyngeal Carcinoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily participate and provide informed consent
- Age between 18 and 65 years, male or non-pregnant female
- Pathological diagnosis of nasopharyngeal non-keratotic carcinoma (WHO type II or III)
- First treatment patients with no prior antitumor therapy and no history of other malignant tumors
- Stage IVa nasopharyngeal carcinoma: TanyN3M0 or T4N0-2M0 (8th AJCC/UICC staging)
- ECOG performance status 0-1
- No serious dysfunction of heart, lung, liver, kidney, or other vital organs
- Hemoglobin ≥ 90 g/L, white blood cells ≥ 4.0 x 10^9/L, platelets ≥ 100 x 10^9/L
- Liver function: ALT and AST less than 2.5 times upper limit of normal, total bilirubin less than 2.0 times upper limit
- Renal function: serum creatinine less than 1.5 times upper limit of normal
You will not qualify if you...
- Recurrent or distant metastatic nasopharyngeal carcinoma
- Keratinized squamous cell carcinoma pathology (WHO type I)
- Systemic or local glucocorticoid therapy within 4 weeks before enrollment
- Participation in other drug clinical trials within 3 months before treatment
- History of allogeneic organ or hematopoietic stem cell transplantation
- Idiopathic pulmonary fibrosis, drug-induced pneumonia, institutional pneumonia, radiation pneumonia with symptoms or requiring steroid treatment, active pneumonia, or other moderate to severe lung diseases affecting lung function
- Comorbidities requiring long-term immunosuppressive drugs or immunosuppressive corticosteroid doses
- Prior use of anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies or similar checkpoint inhibitors with progressive disease at enrollment
- Active or history of autoimmune disease (except vitiligo or childhood asthma in complete remission without intervention)
- Positive HBV DNA ≥ 1000 cps/ml in HIV-positive or HBsAg positive patients; positive HCV antibody with positive HCV RNA
- Anti-infection vaccines received within 4 weeks before enrollment
- Positive pregnancy test or breastfeeding women
- Inability to cooperate with regular follow-up due to psychological, social, family, or geographic reasons
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yi-Jun Hua, Phd.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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