Clinical trial · Interventional
Induction Chemotherapy Combined With Toripalimab in Locoregionally-Advanced Laryngo-Hypopharyngeal Squamous Cell Cancer
NCT04926753CI-TRIAL-00052295unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locoregionally Advanced Laryngo-hypopharyngeal Squamous Cell Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil, Cisplatin, Toripalimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- 5-Fluorouracil(750 mg/m2/d, CIV d1-5) Cisplatin(75mg/m2,d1)/Carboplatin(AUC5, d1) Toripalimab 240mg d1
- interventionNames
- Drug: 5-Fluorouracil, Cisplatin, Toripalimab
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- 36 months
Secondary outcomes (5)
- measure
- Duration of response
- timeFrame
- 36 months
- measure
- Progression free survival rate at 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.