Clinical trial · Interventional
Toripalimab in Combined With Cetuximab，Chemotherapy for Conversion Therapy of Locally Nonresectable OCSCC
Toripalimab in Combination With Cetuximab，Cisplatin and 5-FU for Conversion Therapy of Locally Nonresectable Oral Cavity Squamous Cell Carcinoma （OCSCC）
NCT06081582CI-TRIAL-00070482unknownPhase 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 prospective, single center phase II clinical study with a planned enrollment of 33 patients. The main objective is to evaluate the efficacy and safety of the PD-1 inhibitor toripalimab combined with cetuximab, cisplatin, and 5-FU regimen in the treatment of locally advanced oral squamous cell carcinoma patients who are initially unresectable.
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 |
|---|---|---|---|
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Toripalimab plus Cetuximab，chemotherapy group
- description
- All subjects received 2-cycle conversion therapy with the PD-1 inhibitor toripalimab combined with cetuximab, cisplatin, and 5-FU The dosage of medication used is as follows: Toripalimab: 240mg, Day1, Q3W；Cisplatin: 25mg/m2, Day1-3, Q3W；5-FU: 1000mg/m2, Day1-3, Q3W Cetuximab Day 1, 8, 15, Q3W, 400 mg/m2 initial dose; Afterwards, 250 mg/m2 per week
- interventionNames
- Drug: Toripalimab
Primary outcomes (1)
- measure
- Major pathological response（MPR）
- timeFrame
- through study completion; an average of 1 year
- description
- To determine the major pathological response rate, defined as \<10% viable tumor in the resection specimen, after two cycles of neoadjuvant Toripalimab Plus Cetuximab，Cisplatin and 5-FU in patients with Nonresectable Oral Cavity Squamous Cell Carcinoma （OCSCC）
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed squamous cell carcinoma of tongue, floor of mouth, gingival, buccal * Initial NCCN TNM stage III and IVA patients * PS score 0-1 points * Age≥18 years old * Measurable lesions that meet RECIST 1.1 standards * Normal function of important organs * All patients must provide tissue specimens Exclusion Criteria: * Active, known or suspected autoimmune disease patients * According to the judgment of the researcher, there are accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study by the patients * Merge with other malignant tumors * Subjects with known central nervous system metastasis and/or cancerous meningitis * Uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage * Received significant surgical treatment or obvious traumatic injury within the first 28 days of randomization * Have experienced arterial/venous thrombotic events within the first 6 months of randomization, such as cerebrovascular accidents * Individuals with a history of abuse of psychotropic substances who are unable to quit or have mental disorders * Subjects with any severe and/or uncontrollable diseases * Exclusion criteria related to concomitant medications * Participated in other clinical trials within four weeks * Have received preventive or attenuated vaccines within 4 weeks before the first administration
References
Publications (0)
Data not yet available
No reference posted for this study.