Status:
NOT_YET_RECRUITING
Toripalimab, Endostar Combined With Radiotherapy and Chemotherapy for Nasopharyngeal Carcinoma
Lead Sponsor:
First Affiliated Hospital of Guangxi Medical University
Collaborating Sponsors:
Shandong Cancer Hospital and Institute
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study is to investigate the efficacy and safety of the induction chemotherapy + concurrent chemoradiotherapy（CCRT）combined with toripalimab and endostar treatment, in comparison with the inductio...
Detailed Description
GP-induced chemotherapy combined with concurrent chemoradiotherapy is the standard treatment for the locally advanced nasopharyngeal carcinoma recommended by the guidelines. However, the prognosis for...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- With ECOG score 0-1.
- Subjective aged 18-65 years, male or non-pregnant female.
- Pathologically diagnosed as nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, i.e., the WHO type II or III).
- Stage IVa (8th AJCC/UICC stage) T4 and/or N3, untreated patients with nasopharyngeal carcinoma.
- Agreeing to provide previously stored tumor tissue samples or perform biopsy to collect tumor tissues, which were sent to the central laboratory for the PD-L1 IHC test.
- Hematology: white blood cells ≥ 4000 /μL; neutrophils ≥ 2000 /μL; hemoglobin ≥ 9 g/dL; and platelets ≥ 100000 /μL.
- Liver function: ALT and AST lower than the 1.5 times (1.5 × ) the upper limits of normal (ULN); and total bilirubin \< 1.5 × ULN.
- Renal function: serum creatinine \< 1.5 × ULN.
- Patients signing the informed consents, and willing and able to follow the study plan (visit and treatment plan), laboratory tests, and other research procedures.
- Exclusion criteria:
- Patients with nasopharyngeal carcinoma with recurrence and distant metastasis.
- Pathologically diagnosed as keratinizing squamous cell carcinoma (WHO classification type I).
- Patients who had undergone radiotherapy or systemic chemotherapy.
- Pregnant or breastfeeding females, or females in fertility period while with no effective contraceptive measures.
- Positive for HIV.
- Having suffered from other malignant tumors (except for the cured basal cell carcinoma or cervical carcinoma in situ).
- Having been treated with inhibitors of immune regulatory points (i.e., CTLA-4, PD-1, PD-L1, etc.).
- With complications needing long-term application of immunosuppressive drugs, or systemic or local application of corticosteroids with immunosuppressive doses of comorbidities.
- Patients with immunodeficiency diseases, or a history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, hyperthyroidism, hypothyroidism; patients suffering from vitiligo, or asthma in childhood completely relieved, with no need of any intervention after adulthood could be included; and patients with asthma requiring bronchodilators for medical intervention could not be included).
- With excessive usage of glucocorticoids within 4 weeks.
- Whose laboratory examination values that did not meet the relevant standards within 7 days before participating in the research.
- Patients with markedly reduced heart, liver, lung, kidney and/or bone marrow functions.
- With serious and uncontrolled medical diseases and infections.
- Using other test drugs or in other clinical trials.
- Refusing or failing to sign the informed consent to participate in the trial.
- With other treatment contraindications.
- With personality or mental illness, with no or limited civil capacity.
- Positive for hepatitis B surface antigen (HBsAg), and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 1000 cps/mL.
- Patients positive for the HCV antibody test could only be included in this study with the negative results from the HCV RNA polymerase chain reaction test.
- Unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons.
Exclusion
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04447326
Start Date
June 1 2020
End Date
June 1 2026
Last Update
June 25 2020
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