Clinical trial · Interventional
Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in HNSCC Patients
Phase II Trial of Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in Head and Neck Squamous Cell Carcinoma Patients
NCT04164238CI-TRIAL-00041649unknownPhase 2ClinicalTrials.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 study evaluate either Toripalimab or combined with chemotherapy as neoadjuvant treatment for patients with head and neck squamous cell carcinoma. Participants in arm A receive Toripalimab, in arm B receive Toripalimab plus PC (paclitaxel and carboplatin), arm C with Toripalimab plus modified TPF(paclitaxel and cisplatin and 5-fu).
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 |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fu | Drug | Fluorouracil | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Toripalimab 240mg IV, every 3 weeks;
- interventionNames
- Drug: Toripalimab
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m\^2, IV, Q3W; Carboplatin AUC 5, IV, Q3W
- interventionNames
- Drug: Toripalimab
- Drug: Paclitaxel
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- Arm C
- description
- Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m\^2, IV, Q3W; Cisplatin 25mg/m\^2 IV,d1-d3, Q3W; 5-FU 3000mg/m\^2 CIV 72h, Q3W
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed pathologic or cytologic diagnosis of squamous cell carcinoma of head and neck; * Resectable or potentially resectable lesion; * ECOG PS 0-1; * Age \>18 years old; * At least one target lesion according to RECIST 1.1; * Proper function of the cardiovascular system, liver, kidney and bone marrow for receiving chemotherapy and surgery; Exclusion Criteria: * Distant metastasis; * Second malignancy within 5 years; * Nasopharyngeal carcinoma; * Active autoimmune diseases; * HIV infected; * Required prednisone dose \>=10mg daily; * Heart attack within 6 months; * Stroke within 6 months; * Other conditions that investigators consider the patients are not suitable for PD-1antibody;
References
Publications (0)
Data not yet available
No reference posted for this study.