Health TrialsbyHealthPanel

Neoadjuvant Immunochemotherapy for LAOSCC

ConditionsOral Squamous Cell CarcinomaLocally Advanced Head and Neck Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLai-ping Zhong

About this trial

To evaluate the prognostic efficacy of neoadjuvant immunochemotherapy with tislelizumab, albumin paclitaxel and cisplatin followed by radical surgery and adjuvant therapy compared with standard therapy for patients with locally advanced and resectable oral squamous cell carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1

Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region)

Primary tumor with a clinical stage of III/IVA (T1-2/N1-2/M0 or T3-4a/cN0-2/M0, AJCC 2018)

Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Disqualifiers

Unresolved grade 2 [(Common Terminology Criteria for Adverse Events (CTCAE 5.0)] or higher toxic reactions caused by previous anticancer treatments

Known allergic reaction (grade 3-4) to any ingredients or excipients of the therapy

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

Known history of radiation to head and neck

Trial design

Design model

Parallel

Treatments tested in this trial

  • albumin paclitaxel, cispatin, tislelizumab

    Drug

    Neoadjuvant immunochemotherapy (2 cycles, and 21 days each cycle, 260mg/m2 albumin paclitaxel intravenously on day 1 and day 22, with 75mg/m2 of cisplatin and 200mg of tislelizumab) + radical surgery + adjuvant therapy (radiation/chemoradiation followed by 200mg of tislelizumab, every 3 weeks for one year)

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: Experimental armExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Rate of 2-year event-free survival

Event free survival is calculated from the date of randomization to local recurrence, regional recurrence, distant metastasis, disease progress, or death. The rate of 2-year event free survival is reported as the percentage of patients who are event free survival for 2 years from the date of randomization.

Time frame
2 years
2

Rate of 2-year overall survival

Overall survival is calculated from the date of randomization to death. The rate of 2-year overall survival is reported as the percentage of patients who are overall survival for 2 years from the date of randomization.

Time frame
2 years

Secondary outcomes

1

Rate of 2-year disease-free survival

Disease free survival is calculated from the date of randomization to local recurrence, locoregional recurrence, distant metastasis, or death. The rate of 2-year disease free survival is reported as the percentage of patients who are disease free survival for 2 years from the date of randomization.

Time frame
2 years
2

Rate of major pathological response

Major pathological response is based on the pathological examination on the post-operative specimens after neoadjuvant immunochemotherapy. The rate of major pathological response is reported as the percentage of patients who have major pathological response after NAT.

Time frame
6 months

Other outcomes

Sponsors and contacts

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

Lai-ping Zhong

Lead sponsor

Huashan Hospital

Sponsor institution

Sun Yat-sen University

Collaborator

Fudan University

Collaborator

Central South University

Collaborator

Fujian Medical University

Collaborator

Source ClinicalTrials.gov
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