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Neoadjuvant Treatment of Tislelizumab Combined Chemotherapy for Locally Advanced Oral Squamous Cell Carcinoma ：A Single-arm, Prospective, Phase II Trial

ConditionOral Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWeijia Fang, MD

About this trial

TPF is still recommended as the preferred induction chemotherapy regimen for nonsurgical treatment of patients with LA HNSCC. Based on the KEYNOTE-048 study, all major guidelines recommend PD-1 monotherapy or PD-1 combined with chemotherapy as the new first-line standard treatment for patients with advanced HNSCC. The immunotherapy in operable LA HNSCC was also explored as neoadjuvant therapy due to the excellent data in advanced HNSCC. These explorations have also achieved good results. Therefore, this study aims to explore the pathological remission rate, the long-term benefit and safety of Tislelizumab combined with albumin paclitaxel, cisplatin and fluorouracil for locally advanced oral squamous cell carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed the informed consent form

Histopathological diagnosis of oral squamous cell carcinoma

Age: 18-75 years old , Gender: male and female

Primary tumor with a clinical stage of III/IVb (T1-2N+M0或T3-4N0-3M0, AJCC2018)

Disqualifiers

Known history of malignancy, unless been cured and no recurrence for 5 years

Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy

Known history of radiation, chemotherapy, surgery and immunology-based treatment to head and neck

Active autoimmune disease requiring systemic treatment within 2 years prior to the first dose, or autoimmune disease that may recur or plan treatment as judged by the investigator.

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab

    Drug

    The participants will receive 3 cycles of Tislelizumab, with 21 days each. 200mg of Tislelizumab will be used intravenously on the first day of each cycle.

  • Albumin paclitaxel

    Drug

    The participants will receive 3 cycles of Albumin paclitaxel, with 21 days each. 200mg/m\^2 of Albumin paclitaxel will be used intravenously on the first day of each cycle.

  • Cisplatin

    Drug

    The participants will receive 3 cycles of Cisplatin, with 21 days each. 20mg/m\^2 of Cisplatin will be used intravenously on days 1 through 3 of each cycle.

  • 5-Fluorouracil

    Drug

    The participants will receive 3 cycles of 5-Fluorouracil, with 21 days each. 600mg/m\^2/d of 5-Fluorouracil will be used as a 120-hour continuous intravenous infusion on days 1 through 5.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Pathological Complete Response

Time frame
6 months

Secondary outcomes

1

Major pathologic response

Time frame
6 months
2

Event-free survival

Time frame
2 years
3

Disease-free survival

Time frame
5 years
4

Overall survival

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weijia Fang, MD

Lead sponsor

Zhejiang University

Sponsor institution

Source ClinicalTrials.gov
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