NCT04947241

Toripalimab Combined With Gemcitabine and Cisplatin Treating Resectable Locally Advanced HNSCC

Status unknown Phase 1 Last updated 1 July 2021

What this trial tests

Phase 1 trial testing PD-1 inhibitor+ Gemcitabine + Cisplatin in Locally Advanced Head and Neck Squamous Cell Carcinoma in 20 participants. Status unknown.

Timeline

15 December 2020

Primary endpoint
15 January 2026

15 January 2026

Quick facts

Lead sponsor	Fifth Affiliated Hospital, Sun Yat-Sen University
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	15 December 2020
Primary completion	15 January 2026
Estimated completion	15 January 2026
Sites	1 location across China

Drugs / interventions tested

• PD-1 inhibitor+ Gemcitabine + Cisplatin

Conditions studied

• Locally Advanced Head and Neck Squamous Cell Carcinoma — all drugs for Locally Advanced Head and Neck Squamous Cell Carcinoma →
• Neoadjuvant Therapy — all drugs for Neoadjuvant Therapy →

Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

Who can join

Adults 18 to 70, any sex, with Locally Advanced Head and Neck Squamous Cell Carcinoma or Neoadjuvant Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neoadjuvant toripalimab combined with gemcitabine and cisplatin in resectable locally advanced head and neck squamous cell carcinoma (NeoTGP01): An open label, single-arm, phase Ib clinical trial.
   Huang X, Liu Q, Zhong G, Peng Y, et al · · 2022 · cited 55× · PMID 36224603 · DOI 10.1186/s13046-022-02510-2
2. The double life of a chemotherapy drug: Immunomodulatory functions of gemcitabine in cancer.
   Larson AC, Doty KR, Solheim JC. · · 2024 · cited 21× · PMID 38770637 · DOI 10.1002/cam4.7287
3. Evaluating the efficacy and safety of different neoadjuvant immunotherapy combinations in locally advanced HNSCC: a systematic review and meta-analysis.
   Liu C, Li M, Liu X, Shi T, et al · · 2024 · cited 5× · PMID 39267732 · DOI 10.3389/fimmu.2024.1467306
4. Application of Immune Checkpoint Inhibitors in Cancer.
   Chen Z, Song Z, Den S, Zhang W, et al · · 2025 · cited 2× · PMID 40787068 · DOI 10.1002/mco2.70176
5. [Application of neoadjuvant immunotherapy in head and neck squamous cell carcinoma: From mechanisms to clinical practice].
   Chen J, Zhang J, Kuang Y, Chen Y, et al · · 2025 · PMID 42032983 · DOI 10.11817/j.issn.1672-7347.2025.250271
6. Synergistic Potential of Immune Checkpoint Inhibitor Combined with Neutrophil-Targeted Therapy in Cancer Immunotherapy.
   Shi H, Wang J, Wang Z, Li Y, et al · · 2026 · PMID 41993094 · DOI 10.34133/research.1210
7. The emerging role of neoadjuvant immunotherapy in locally advanced oral squamous cell carcinoma: progress and challenges.
   Zhao TC, Dai YB, Zhou ZH, Huang YY, et al · · 2026 · PMID 41532448 · DOI 10.1097/js9.0000000000004783
8. Evaluation of neoadjuvant immunotherapy regimens for head and neck squamous cell carcinoma: a systematic review and single-arm and network meta-analysis.
   Ye Z, Fan W, Zeng B, Tan R, et al · · 2026 · PMID 41504501 · DOI 10.1097/js9.0000000000004689