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

NCT ID: NCT04926753

Last Updated: 2021-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2024-06-01

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.

Conditions

Locoregionally Advanced Laryngo-hypopharyngeal Squamous Cell Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

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

Group Type: EXPERIMENTAL

5-Fluorouracil, Cisplatin, Toripalimab

Intervention Type: DRUG

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.

Interventions

5-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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jun Zhang

Chair of Department of Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mingliang Xiang, MD & Ph.D

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Jun Zhang, MD & Ph.D

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Department of Oncology, Ruijin Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Chengfang Shangguan, MD & Ph.D

Role: CONTACT

sgcf11674@rjh.com.cn

+862164741635

Facility Contacts

Jun Zhang, MD & Ph. D

Role: primary

junzhang10977@sjtu.edu.cn

+86-13818332497

Other Identifiers

DETECTOR-1

Identifier Type: -

Identifier Source: org_study_id