Clinical trial NCT04926753: Induction Chemotherapy Combined With Toripalimab in Locoregionally-Advanced Laryngo-Hypopharyngeal Squamous Cell Cancer
Official title: Induction Chemotherapy Combined With Toripalimab in Locoregionally-Advanced Laryngo-Hypopharyngeal Squamous Cell Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Locoregionally Advanced Laryngo-hypopharyngeal Squamous Cell Cancer
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2021-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate
timeFrame: 36 months
Secondary outcomes:
measure: Duration of response
timeFrame: 36 months
measure: Progression free survival rate at 12 months
timeFrame: 12 months
measure: Laryngo-preservation rate at 12 months
timeFrame: 12 months
measure: Overall survival rate at 24 months
timeFrame: 24 months
measure: Safety: adverse events as assessed by CTCAE v5.
timeFrame: 36 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Oncology, Ruijin Hospital
Study officials:
affiliation: Ruijin Hospital
name: Mingliang Xiang, MD & Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Jun Zhang, MD & Ph.D
role: PRINCIPAL_INVESTIGATOR
References: