Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC

NCT05125055 | Recruiting Phase 2

• 1 other identifier: Illuminate-2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the pathological efficacy of neoadjuvant Toripalimab and Albumin paclitaxel /Cisplatin (TTP) with Docetaxel/ Cisplatin/ 5-flurouracil (TPF) for patients with locally advanced resectable oral squamous cell carcinoma (OSCC), and to determine the safety of neoadjuvant TTP. In order to explore a better protocol of neoadjuvant therapy to improve the efficacy in patients with locally advanced OSCC.

Conditions

Oral Squamous Cell Carcinoma; Neoadjvant Therapy; Anti-PD-1; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Major pathologic response

  The major pathologic response (MPR): the percentage of tumor cells before and after treatment was compared according to biopsy specimens before neoadjuvant therapy and pathological specimens after surgery; the percentage of residual viable tumor (RVT) cells was evaluated on resected tumor slides. MPR was defined as ≤ 10% RVT%.

  3 months

Secondary Outcomes (2)

• 2-year disease-free survival rate

  24 months

• 2-year overall survival rate

  24 months

Study Arms (2)

Neoadjuvant TTP

EXPERIMENTAL

The participants will receive two cycles of intravenous Albumin paclitaxel (260mg/ m\^2), Cisplatin (75mg/ m\^2) and Toripalimab (anti-PD-1 inhibitor, 240 mg) on d1 and d22.

Drug: Toripalimab (anti-programmed death-1 inhibitor); Drug: Albumin paclitaxel; Drug: Cisplatin

Neoadjuvant TPF

ACTIVE COMPARATOR

The participants will receive two cycles of intravenous Docetaxel (75 mg/m\^2) on d1 and d22, Cisplatin (75 mg/m\^2) on d1 and d22, and 5-Fluorouracil (750 mg/m\^2/day) for 5 days (d1-5 and d22-26), the interval is 16±1 days.

Drug: Cisplatin; Drug: Docetaxel; Drug: 5-Fluorouracil

Interventions

Toripalimab (anti-programmed death-1 inhibitor) DRUG

The participants will receive two cycles of Toripalimab, with 21 days each. 240mg of Toripalimab will be used intravenously on the first day of each cycle.

Neoadjuvant TTP

Albumin paclitaxel DRUG

The participants will receive two cycles of Albumin paclitaxel, with 21 days each. 260mg/m\^2 of Albumin paclitaxel will be used intravenously on the first day of each cycle.

Neoadjuvant TTP

Cisplatin DRUG

The participants will receive two cycles of Cisplatin, with 21 days each. 75mg/m\^2 of Cisplatin will be used intravenously on the first day of each cycle.

Neoadjuvant TPF; Neoadjuvant TTP

Docetaxel DRUG

The participants will receive two cycles of Docetaxel, with 21 days each. 75mg/m\^2 of Docetaxel will be used intravenously on the first day of each cycle.

Neoadjuvant TPF

5-Fluorouracil DRUG

The participants will receive two cycles of 5-Fluorouracil, with 21 days each. 750mg/m\^2/d of 5-Fluorouracil will be used as a 120-hour continuous intravenous infusion on days 1 through 5.

Neoadjuvant TPF

Eligibility Criteria

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

You may qualify if:

• Age: 18-75 years old
• Gender: male and female
• Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-2
• 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, AJCC2018)
• 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 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
• Uncontrollable hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>90 mmHg) or cardiovascular diseases with clinical significance (such as activity), such as cerebrovascular accidents (≤ 6 months before screening), myocardial infarction (≤6 months before screening), unstable angina pectoris, NYHA grade II or above congestive heart failure, or severe arrhythmia that cannot be controlled by drugs or has a potential impact on trial treatment
• 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

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 20011, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

toripalimab; Cisplatin; Docetaxel; Fluorouracil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Lai-ping Zhong, MD, PhD

CONTACT

+862123271699; zhonglp@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: November 18, 2021
• Study Start: October 1, 2021
• Primary Completion: September 30, 2024
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CN (1)