HNSCC
Conditions
Interventions
experimental group:anti-PD-1+hyperthermia
control group:anti-PD-1
Sponsors
Shanghai Ninth People’s Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) aged 18-75 years; (2) advanced or recurrent oral squamous cell carcinoma confirmed by histology, and further treatment is not suitable for radiotherapy and operation; (3) according to the RECIST standard, there should be at least one measurable focus (with spiral CT / MRI, the diameter of the focus >= 10 mm, and with spiral CT scan = 1.5 x 109 / L, platelet (PLT) >= 80 x 10^9 / L, total bilirubin (TBI) >= 1.5 x upper limit of normal value (2mg / dl), alanine aminotransferase (ALT), aspartate aminotransferase (AST) >= 2 x upper limit of normal value; coagulation parameters (>= 1.25 × upper limit of normal value); (5) no chemotherapy, radiotherapy and biotherapy were received within 4 weeks. (6) estimated survival time >= 3 months; (7) ECoG physical state score 0-2; (8) the patient voluntarily participated in the trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: (1) there are still any unsolved CTCAE grade 2 or above toxic reactions caused by previous anti-cancer treatment; (2) patients with locally progressive diseases who are ready for radical treatment (including surgery and / or chemotherapy and / or radiotherapy) during the trial; (3) recurrence within half a year after treatment with taxol or platinum chemotherapy drugs; (4) with obvious diseases or dysfunction of liver, kidney, heart, nerves, spirit and other important organs, such as diabetes mellitus that is not well controlled, hypertension that is not well controlled, liver failure, unstable angina pectoris, history of myocardial infarction within 6 months, class III or IV congestive heart failure of new York Heart Association, history of cerebrovascular accident within 6 months, serious nerve or mental illness. Patients with active severe clinical infection (CTCAE grade 3 or above). (5) patients with severe coagulation mechanism disorder and bleeding tendency; (6) having a history of organ transplantation, or suffering from other acquired and congenital immune system diseases; (7) those who are allergic to the test drug; (8) pregnant or lactating women, or pregnant planners; (9) currently or recently (within 28 days before randomization) receive other experimental drugs or participate in other research trials; (10) other unsuitable participants in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Countries
China
Contacts
Public ContactWei Guo
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed