laryngopharyngeal carcinoma
Conditions
Interventions
Treatment group:TP (Docetaxel + Cisplatin) combined with teriprizumab induction chemotherapy
Control group:Concurrent chemoradiation
Sponsors
Sichuan Cancer Hopspital/Institute
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years; 2. Laryngopharyngeal squamous cell carcinoma diagnosed by pathological tissue; 3. The clinical staging is III-IVa (the eighth edition TNM staging)); 4. ECOG score 0-1 points; 5. Have not received any anti-tumor therapy such as radiotherapy, chemotherapy, immunotherapy or biological therapy for laryngopharyngeal carcinoma in the past; 6. No immunotherapy and radiotherapy and chemotherapy contraindications; 7. The functional level of major organs meets the following standards: (1) Routine blood examination standards should meet: WBC>=3.0x10^9/L, ANC>=1.5x10^9/L, PLT>=100x10^9/L, Hb>=90g/L (no blood transfusion and blood products in 14 days, no use G-CSF and other hematopoietic stimulating factors corrected); (2) Biochemical examination should meet the following standards: TBIL=60ml/min (Cockcroft-Gault formula); (3) Good coagulation function: defined as the international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; if the subject is receiving anticoagulation therapy, as long as the PT is within the intended use range of anticoagulation drugs; 8. Myocardial enzyme spectrum is within the normal range; 9. Women of childbearing age must have taken reliable contraceptive measures, or have a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and is willing to use effective methods of contraception during the trial and within 2 months after the last anti-PD-1 antibody administration. For male subjects whose partners are women of childbearing age, effective methods of contraception should be used during the trial and within 2 months after the last anti-PD-1 antibody administration; 10. The subject voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Active infection or fever of unknown cause occurred during the screening period and before the first administration> 38.5? (according to the judgment of the investigator, the subject can be included in the group due to fever caused by the tumor); 2. Patients who have used antibiotics continuously for 5 days or more within 1 month before enrollment; 3. Suffer from any active autoimmune diseases or have a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism [Can be included after hormone replacement therapy is normal]); Patients with vitiligo or asthma in childhood that have been completely relieved without any intervention after adulthood can be included, asthma patients who require medical intervention with bronchodilators cannot be included; 4. Suffering from congenital or acquired immune function defects (such as HIV infection), active hepatitis B (HBV-DNA >= 10^4 copies/ml) or hepatitis C (hepatitis C antibody positive, and HCR-RNA is higher than the detection limit of the analysis method) ; 5. If the subject has undergone major surgery, the toxic reaction and/or complications caused by the surgical intervention must be fully recovered before starting treatment; 6. Live vaccines have been vaccinated within 4 weeks before the first use of the study drug, and inactivated virus vaccines for seasonal influenza injections are allowed, but live attenuated influenza vaccines for nasal use are not allowed; 7. Women during pregnancy or lactation; 8. Past or simultaneous suffering from other uncured malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ and superficial bladder cancer; 9. As judged by the investigator, the subject has other factors that may cause him to be forced to terminate the study halfway, such as suffering from other serious diseases (including mental illness) requiring combined treatment, severely abnormal laboratory test values, family or social factors, thatt may affect the safety of subjects or the collection of experimental data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Safety and tolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathologically significant response rate;Quality of life; | — |
Countries
China
Contacts
Public ContactLang Jinyi
Sichuan Cancer Hopspital/Institute
Outcome results
None listed