NCT04947241

Toripalimab Combined With Gemcitabine and Cisplatin Treating Resectable Locally Advanced HNSCC

Phase Ib Clinical Study of Toripalimab Combined With Gemcitabine and Cisplatin Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Head and Neck Squamous Cell Carcinoma (HNSCC) is the most common malignant tumor of the head and neck, accounting for 90% of head and neck malignancies, and 16% to 40% of systemic malignancies. There are 60,000 new cases reported annually worldwide, and the incidence and mortality are increasing year by year, however,the 5-year survival rate under standard treatment is only 50%. 70%\~80% of patients already developed into locally advanced status (stage II-IVa) when they are first diagnosed. The treatment principle is mainly determined by the clinical stage and location of the tumor, various factors affecting the prognosis and the patient's tolerance. Locally advanced head and neck squamous cell carcinoma has a higher probability of local/regional failure and distant metastasis after treatment. Therefore, in recent years, the use of neoadjuvant therapy (NAC) followed by surgery or radiotherapy has been advocated. Surgical treatment is still one of the preferred treatments for local head and neck squamous cell carcinoma. TPF (Docetaxel + Cisplatin + Fluorouracil) regimen is considered as the standard regimen of induced chemotherapy for head and neck squamous cell carcinoma (especially in laryngeal cancer), which can significantly reduce the patient's distant metastasis rate and prolong overall survival ( OS). Nevertheless, the therapeutic effect of neoadjuvant therapy on head and neck squamous cell carcinoma has reached a bottleneck. In recent years, PD-1 inhibitors have achieved significant effects in the field of tumor therapy and have been approved for the treatment of various tumors including head and neck tumors. And a number of clinical trials have shown that PD-1 inhibitors can significantly prolong the OS of patients. Altogether, the investigators launch an open-label, single-arm, phase Ib clinical trial of PD-1 inhibitor plus chemotherapy in patients with resectable HNSCC to explore the safety and efficacy of the treatment. The study comprises two stages, run-in and case development.

Detailed description

In the first phase, we would observe the initial six patients lasting 90 days from the first day of treatment(or 30 days after surgery) to evaluate if the dose-limited- toxicity DLT would occur in two of them or more. 3、If the dose-limited- toxicity would be recorded in no more than one patient, the trail would continue until meeting the scheduled size of population, otherwise the trial would stop. The further investigation would be launch to review the data thoroughly and modify the protocol.

Conditions

• Locally Advanced Head and Neck Squamous Cell Carcinoma
• Neoadjuvant Therapy

Interventions

Type	Name	Description
DRUG	PD-1 inhibitor+ Gemcitabine + Cisplatin	Before surgery, patients will receive therapy as follows: PD-1 inhibitor: 240mg (day1) , intravenous, Q3W, 2cycles; cisplatin: 80 mg/m2(day1), intravenous , intravenous, Q3W, 2cycles Gemcitabine: 1000mg/m2(day1and day8), intravenous, Q3W, 2cycles

Timeline

• Start date: 2020-12-15
• Primary completion: 2026-01-15
• Completion: 2026-01-15
• First posted: 2021-07-01
• Last updated: 2021-07-01

Locations

1 site across 1 country: China