Neoadjuvant Immunochemotherapy for LAOSCC

NCT06258811 | Recruiting Phase 3 DMC

• 1 other identifier: TopHill
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Squamous Cell Carcinoma; Locally Advanced Head and Neck Carcinoma

Keywords

Oral squamous cell carcinoma; Neoadjuvant immunochemotherapy

Outcome Measures

Primary Outcomes (2)

• 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.

  2 years

• 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.

  2 years

Secondary Outcomes (2)

• Rate of 2-year disease-free survival

  2 years

• Rate of major pathological response

  6 months

Study Arms (2)

Experimental arm

EXPERIMENTAL

Neoadjuvant immunochemotherapy (albumin paclitaxel+cisplatin+tislelizumab) + radical surgery + adjuvant therapy (radiation/chemoradiation + tislelizumab maitainance)

Drug: albumin paclitaxel, cispatin, tislelizumab

Control arm

NO INTERVENTION

Standard therapy of radical surgery +adjuvant therapy (radiation/chemoradiation)

Interventions

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)

Experimental arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Blood routine: white blood cells (WBCs) \>3,000/mm3, hemoglobin \>8 g/L, platelets \>80,000/mm3
• Liver function: alanine amino transferase/aspartate amino transferase (ALAT/ASAT) \<2.5 times the upper limit of normal and bilirubin \<1.5 times the upper limit of normal
• Renal function: Serum creatinine \<1.5 times the upper limit of normal
• Coagulation function: INR、PT、APTT\<1.5 times the upper limit of normal
• Signed the informed consent form

You may not qualify if:

• 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
• Active severe clinical infection (\> National Cancer Institute (NCI)-CTCAE version 5.0 grade 2 infection)
• Obvious cardiovascular abnormalities \[such as myocardial infarction, superior vena cava syndrome, grade 2 or higher heart disease diagnosed according to the New York Heart Association (NYHA) classification 3 months before enrollment\]
• Patients receiving immunology-based treatment for any reason
• Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy
• Pregnant or lactating women
• Known active hepatitis B or C. Active hepatitis B is defined as a known HBsA positive with HBV DNA≥500 IU/mL. Active hepatitis C is defined as a known hepatitis C antibody positive and a known amount of hepatitis C virus HCV RNA results greater than the lower limit of detection. The presence of other serious liver diseases, including chronic autoimmune liver disease, primary biliary cirrhosis or sclerosing cholangitis, alcoholic liver disease, or non-alcoholic steatohepatitis (NASH)
• Complicated with severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or history of allogeneic tissue/organ transplantation, stem cell or bone marrow transplantation, or solid organ transplantation
• Participation in other clinical trials within 30 days before enrollment
• Other situations that the investigator considers unsuitable with respect to participating in the trial

Sponsors & Collaborators

• Lai-ping Zhong: lead
• Sun Yat-sen University: collaborator
• Fudan University: collaborator
• Central South University: collaborator
• Fujian Medical University: collaborator

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, 200040, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Lai-ping Zhong, MD, PhD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lai-ping Zhong, MD, PhD

CONTACT

+862152888915; zhonglp@hotmail.com

Ying-ying Huang, MD

CONTACT

+862152889999; kqyxyhyy@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Randomized 1:1 to experimental or control arm. Experiment arm: neoadjuvant immunochemotherapy (2 cycles, and 21 days each cycle, 260mg/m2 albuminpaclitaxel 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) Control arm: standard therapy of radical surgery +adjuvant therapy (radiation/chemoradiation)

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: February 20, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2 years after completion of the trial, for 6 months.
• Access Criteria: Access to IPD data can be obtained upon scientifically sound request from the study PI, who will contact the Clinical Research Unit, Huashan Hospital, Fudan University. Access will be released after the approval from the Clinical Research Unit.

Locations

CN (1)