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Toripalimab Combined With Gemcitabine and Cisplatin Treating Resectable Locally Advanced HNSCC

NCT04947241 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-07-01

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Fifth Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Zhigang Liu, M.D. · Fifth Affilliated Hospital of Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2026-01-15
Completion
2026-01-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04947241 on ClinicalTrials.gov