Nasopharyngeal carcinoma
Conditions
Interventions
Experiment group:Camrelizumab in combination with Anlotinib
Sponsors
The Second Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old, both male and female; 2. Histologically confirmed moderately differentiated or undifferentiated locally recurrent/metastatic nasopharyngeal carcinoma (WHO type II-III); 3. Patients with clinical stage IVb (according to the 8th edition of the AJCC TNM staging system for nasopharyngeal carcinoma) who have failed at least one line of platinum-based chemotherapy (chemotherapy or combination), or patients with local recurrence who are not suitable for local treatment or radical treatment.Definition of treatment failure: progression on or after chemotherapy after metastasis; progression within 6 months after concurrent chemoradiotherapy can be counted as first-line treatment.All patients who change the treatment regimen due to drug intolerance are not considered as treatment failure; 4. According to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), at least one measurable lesion (except brain metastases): 5. ECOG score 0 to 1; 6. Expected survival >= 12 weeks; 7. The function of vital organs meets the following requirements (14 before the first use of study drug are not allowed to use any blood components, cell growth factor, leukocyte-elevating drugs, platelet-elevating drugs, anemia correction drugs): (1) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; (2) Platelets >= 100 x 10^9/L; (3) Hemoglobin >= 9 g/dL; (4) Serum albumin >= 2.8 g/dL; (5) Total bilirubin <= 1.5 x ULN, ALT, AST and/or ALP <= 2.5 x ULN; if there is liver metastasis, ALT and/or AST <= 5 x ULN; if liver metastasis or bone metastasis ALP <= 5 x ULN; (6) Serum creatinine <= 1.5 x ULN or creatinine clearance greater than 60 mL/ming); (7) Activated partial thromboplastin time (APTT) and international normalized ratio (INR) <= 1.5 x ULN (for anticoagulant therapy with stable dose, such as low molecular weight heparin or warfarin, the INR can be screened within the expected therapeutic range of anticoagulants). 8. Female subjects of childbearing potential, as well as male subjects whose partners are not of childbearing potential, need to use a medically recognized contraceptive (such as intrauterine device, contraceptives or condoms) during study treatment, and at least 3 months after the last use of caritinib and 6 months after the last use of anlotinib; 9. Subjects voluntarily join this study, sign informed consent, have good compliance, and cooperate with follow-up; 10. The investigator believes that they can benefit.
Exclusion criteria
Exclusion criteria: 1.History of gastrointestinal perforation within 6 months before the first medication; 2.Active ulcer, intestinal perforation, intestinal obstruction; 3.Hyperactive/venous thrombotic events occurred within 6 months before screening, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except venous thrombosis caused by previous chemotherapy) and pulmonary embolism; 4.Patients with clear bleeding tendency, including: locally active ulcer lesions, and fecal occult blood (+ +) can not be, melena, hematemesis within 2 months, etc.; 5.Imaging showed that the tumor has invaded important blood vessels or the investigator judged that the patient has a very high possibility of invading important blood vessels during cancer treatment and causing fatal bleeding; 6.Patients with hypertension and antihypertensive drug treatment can not be reduced to the normal range (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), suffering from above grade I arrhythmia (including QTc interval prolongation > 450 ms in men, Female > 470 ms) and grade I cardiac insufficiency (refer to NYHA functional classification); 7.Renal insufficiency: urine routine proteinuria > 2 + and confirmed 24-hour urinary protein quantification > 1.0g; 8.Received potent CYP3A4 inhibitors within one week before enrollment, Patients who have received potent CYP3A4 inducers 2 weeks before study; 9.Patients with uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage; 10.Patients who have a history of allergy to any component of camrelizumab and anlotinib; 11.Patients with multiple factors affecting oral drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.); 12.Patients who have previously received VEGFR small molecule tyrosine kinase inhibitors (such as familtinib, sorafenib, sunitinib, regorafenib, apatinib, etc.); 13.Patients who have received any of the following treatments: (1) Previous treatment with anti-PD-1 or anti-PD-L1 antibodies; (2) Patients who have received any investigational drugs within 4 weeks before the first use of the study drug; (3) Subjects who need to be given corticosteroids (> 10 mg prednisone equivalent dose per day) or other immunosuppressive agents for systemic treatment within 2 weeks before the first use of the study drug, Corticosteroids are excluded for local inflammation of the esophagus and prevention of allergy and nausea and vomiting. Other special circumstances require communication with the sponsor.In the absence of active autoimmune diseases, inhaled or topical steroids and adrenocorticotropic hormone replacement at doses > 10 mg/day prednisone are allowed; (4) Anti-tumor vaccinees or live vaccines 4 times before the first dose of study drug; (5) Excessive surgery or severe trauma 4 times before the first use of study drug; (6) Another clinical study, unless it is an observational (non-interventional) clinical study or interventional clinical study follow-up; 14.A history of active autoimmune diseases, autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); except vitiligo or recovered childhood asthma/allergy, adults do not require any intervention; autoimmune-mediated hypothyroidism treated with stable doses of thyr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate;Duration of Response;Median Overall survival; | — |
Countries
China
Contacts
Public ContactDing Jianwu
The Second Affiliated Hospital of Nanchang University
Outcome results
None listed