Locoregionally Advanced Laryngo-hypopharyngeal Squamous Cell Cancer
Conditions
Brief summary
This is a non-randomized phase 1, open-labeled clinical study, 1-arm, single center, to observe efficacy and safety of chemotherapy plus PD-L1 antibody Toripalimab every 21 days for 2 cycles as induction regimen in locoregionally-advanced laryngo-hypopharyngeal squamous cell cancer patients.
Detailed description
Locoregionally advanced laryngo-hypopharyngeal squamous cell cancer patients have the demand of laryngo-preservation. Induction chemotherapy (FP) combined with Toripalimab (a humanized IgG4 monoclonal antibody against PD-1) will be given. This regimen will be given every 21 days for 2 cycles. Radiological examinations and PET(FDG/FAPI) examinations pre/post-treatment will be administrated for response evaluation.
Interventions
DRUG5-Fluorouracil, Cisplatin, Toripalimab
Drug: FP combined with Toripalimab Combination drugs: 5-Fluorouracil(F), Cisplatin/Carboplatin(P) and Toripalimab every 21 days for 2 cycles This is a single-arm study with all patients receiving these three drugs.
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male/female patients aged≥18 years. 2. Histologically confirmed Laryngo-hypopharyngeal squamous cell cancer, previously untreated (including surgery/radiotherapy/chemotherapy/immunotherapy). 3. Locoregionally-advanced disease stage cT2-4N0-3M0. 4. ECOG performance status 0 to 1. 5. Adequate organ function: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥70g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN. 6. HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA\<500IU/ml (or 2500 copies/ml). 7. Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment. 8. Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form.
Exclusion criteria
1. Pregnancy or children bearing potential. 2. Metastasis. 3. Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. 4. Have other malignant tumors within 5 years, except for fully treated basal cell/squamous cell skin cancer/cervical cancer 5. Uncontrolled clinical symptoms or diseases of the heart, such as: heart failure above NYHA II, unstable angina, myocardial infarction within 6 months; 6. With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (\>10mg/d prednisone). 7. With uncontrollable complications 8. Inadequate organ function 9. known hypersensitivity reaction to any of the study drugs or components. 10. Other unsuitable conditions determined by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | 36 months |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response | 36 months |
| Progression free survival rate at 12 months | 12 months |
| Laryngo-preservation rate at 12 months | 12 months |
| Overall survival rate at 24 months | 24 months |
| Safety: adverse events as assessed by CTCAE v5. | 36 months |
Countries
China
Contacts
Primary ContactChengfang Shangguan, MD & Ph.D
Outcome results
None listed