Clinical trial · Interventional
Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma
Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma: A Multicenter Randomized Controlled Study
NCT07248956CI-TRIAL-00099541recruitingPhase 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 is a multi-center, randomized controlled, prospective clinical study.
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 |
|---|---|---|---|
| Hypopharyngeal Carcinoma | Hypopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Albumin-Bound Paclitaxel /nab-Paclitaxel | Drug | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Definitive radiotherapy | Radiation | — | UNRESOLVED |
| Finolizumab | Drug | — | UNRESOLVED |
| Surgery with postoperative radiotherapy or chemoradiotherapy. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- neoadjuvant therapy followed by surgery and (C)RT group
- description
- Patients initially receive immunotherapy with Finolizumab and chemotherapy with albumin-bound paclitaxel and cisplatin. Patients with response of complete reaction (CR)/partial reaction (PR)≥50% after neoadjuvant chemotherapy then receive surgery, followed by postoperative radiotherapy or chemoradiotherapy.
- interventionNames
- Drug: Finolizumab
- Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel
- Drug: Cisplatin
- Procedure: Surgery with postoperative radiotherapy or chemoradiotherapy.
- type
- ACTIVE_COMPARATOR
- label
- neoadjuvant therapy followed by CCRT group
- description
- Patients initially receive immunotherapy with Finolizumab and chemotherapy with albumin-bound paclitaxel and cisplatin. Patients with response of complete reaction (CR)/partial reaction (PR)≥50% after neoadjuvant chemotherapy then receive definitive radiotherapy with concurrent cisplatin-based chemotherapy.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Willingness to provide written informed consent; 2. Age ≥18 and ≤75 years; 3. Treatment-naïve for malignant disease; 4. Resectable stage III-IVA hypopharyngeal carcinoma with response of PR ≥ 50% after neoadjuvant therapy according to RECIST 1.1 ; 5. ECOG performance status 0-2. Exclusion Criteria: 1. Pregnancy or breastfeeding status; 2. Hypersensitivity to sintilimab, nab-paclitaxel, or their formulation components; 3. Poorly controlled cardiovascular conditions or other diseases; 4. Active or documented history of autoimmune diseases requiring systemic treatment; 5. Synchronous or metachronous malignancies; 6. Other conditions deemed ineligible for the study by investigators.
References
Publications (0)
Data not yet available
No reference posted for this study.