Induction Chemotherapy Combined With Toripalimab in Locoregionally-Advanced Laryngo-Hypopharyngeal Squamous Cell Cancer

Phase 1

• Conditions: Locoregionally Advanced Laryngo-hypopharyngeal Squamous Cell Cancer
• Interventions: Drug: 5-Fluorouracil, Cisplatin, Toripalimab

• Registration Number: NCT04926753
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Status Verified: 2021-06
• Study Start: 2021-06-01
• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-09
• Last Update Submitted: 2021-06-14
• Study First Posted: 2021-06-15
• Last Update Posted: 2021-06-16
• Primary Completion: 2022-12-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	5-Fluorouracil, Cisplatin, Toripalimab	5-Fluorouracil(750 mg/m2/d, CIV d1-5) Cisplatin(75mg/m2,d1)/Carboplatin(AUC5, d1) Toripalimab 240mg d1

Primary Outcome Measures

Name	Time	Method
Objective response rate	36 months

Secondary Outcome Measures

Name	Time	Method
Safety: adverse events as assessed by CTCAE v5.	36 months
Progression free survival rate at 12 months	12 months
Duration of response	36 months
Laryngo-preservation rate at 12 months	12 months
Overall survival rate at 24 months	24 months

Trial Locations

Locations (1)

Department of Oncology, Ruijin Hospital; 🇨🇳 Shanghai, China