Clinical trial · Interventional
A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma
A Phase II Study of Neoadjuvant Bio-chemotherapy With Cetuximab, Paclitaxel, and Cisplatin (CPC) Followed by Cetuximab-based Concurrent Bio-radiotherapy in High-risk Locally Advanced Oral Squamous Cell Carcinoma (OSCC)
- 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)
Surgical resection followed by concurrent chemoradiotherapy is considered as the standard of care for locally advanced OSCC (LAOSCC). Although the treatment could provide prompt local control, but it is also associated with high incidence of distant failure. Systemic chemotherapy given either before (neoadjuvant) or after (adjuvant) definitive local treatment has been extensively evaluated to improve the clinical outcome in LAOSCC. Regimens of taxane/cisplatin-based combinations have been shown to improve the treatment outcome of patients with locally advanced head and neck squamous cell carcinoma (HNSCC) in neoadjuvant setting. Recently, cetuximab (Erbitux®), a monoclonal antibody against epidermal growth factor receptor (EGFR), has also been proven to be an efficient agent for advanced and/or refractory HNSCC with acceptable toxicity profiles. In current study, we shall evaluate the feasibility, efficacy and safety of a triplet bio-chemotherapy consisting of cetuximab, paclitaxel, and cisplatin followed by cetuximab-based concurrent bio-radiotherapy (CBRT) in patients with LAOSCC.
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 |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab,Paclitaxel,Cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- open label
- description
- an open-labelled, single-arm
- interventionNames
- Drug: Cetuximab,Paclitaxel,Cisplatin
Primary outcomes (1)
- measure
- The primary endpoint is the overall response rate after completion of the assigned treatment.
- timeFrame
- 18 weeks
Secondary outcomes (1)
- measure
- Secondary endpoints include the response rate after neoadjuvant therapy, progression-free survival, overall survival, biomarker prediction, and toxicity.
- timeFrame
- >2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. High-risk, locally advanced (TxN2b\~3 or unresectable T4, M0) OSCC 2. Histologically confirmed squamous cell carcinoma 3. Performance status: Eastern Cooperative Oncology Group performance status (ECOG) 0-1 4. age 18 years or older, less than 70 years of age 5. Having signed informed consent 6. Measurable disease by CT or MRI 7. Adequate hematologic, hepatic and renal function Exclusion Criteria: 1. Prior radiotherapy for targeted lesions, chemotherapy, EGFR pathway targeting therapy 2. Prior surgery for cancer except for the purpose of diagnostic biopsy 3. Concomitant active 2nd malignancies or disease-free of malignancies \< 3 years before the study except adequately treated in situ cervical cancer, or non-melanoma skin cancer 4. Concomitant anticancer therapies within the past 28 days 5. Severe cardiopulmonary diseases and other systemic disease under poor control 6. Uncontrolled chronic neuropathy 7. Women who are positive of pregnancy, or in breast-feeding 8. Known allergy to any study treatment 9. Legal incapacity 10. Significant disease which, in the investigator's opinion, would exclude the patient from the study
References
Publications (0)
Data not yet available