Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Tislelizumab

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Neoadjuvant therapy ( 3 cycles ) ： Cycle1、2、3（Cycle length: 21 days）：Tislelizumab(IV) , dose= 200mg, day=1; Cisplatin(IV) , dose=75 mg/m2, or Carboplatin(IV) , AUC=5, day=1; Nab-paclitaxel (IV), dose=260mg/m2, day=1.

Following surgical resection, lymph node positive participants receive 200 mg Tislelizumab Q3W plus chemoradiotherapy as adjuvant therapy. Lymph node negative participants receive 200 mg Tislelizumab Q3W as adjuvant therapy.

Following surgical resection, lymph node positive participants receive chemoradiotherapy as adjuvant therapy. Lymph node negative participants receive follow-up.

Tislelizumab 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

Tislelizumab（neoadjuvant）

Cisplatin 75 mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

Cisplatin （neoadjuvant）

Nab-paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

Nab-paclitaxel （neoadjuvant）

Surgical resection

Cisplatin 100 mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

Cisplatin（adjuvant）

Tislelizumab（adjuvant）

Radiation

Cisplatin AUC=5 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

Carboplatin（neoadjuvant）

Carboplatin（adjuvant）

Bin Wei

Qunxing Li

Song Fan, Doctor

A prospective, randomized, open-label, multicenter Phase 2 trial designed to compare the efficacy and safety of Tislelizumab combined with chemotherapy followed by surgery versus up-front surgery in resectable clinically node-negative head and neck squamous cell carcinoma.

Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Clinically Node-negative Head and Neck Squamous Cell Carcinoma

Time from randomization until recurrence of tumor or death from any cause

Proportion of positive lymph nodes in resection specimens among total subjects

High-grade adverse events were tabulated using worst grade per Common Terminology Criteria for Adverse Events, National Cancer Institute (NCI CTCAE) Version 5.0 criteria.

pCR is defined as the absence of invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes.

MPR is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes

Lymph node division in patients with lymph node metastasis

EFS is the time from the date of randomization to the date of first record of any of the following events: disease progression; local or distant recurrence as assessed with imaging or biopsy as indicated; or death due to any cause.

Time from randomization to subject's death from any cause

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Associate Professor

Antibodies

Immunoglobulins

Neoadjuvant therapy ( 3 cycles ) ： Cycle1（Cycle length: 21 days）：Tislelizumab (IV), dose= 200mg, day=1; Cisplatin (IV), dose=75 mg/m2, or Carboplatin (IV), AUC=5, day=1; Nab-paclitaxel (IV), dose=260mg/m2, day=1.

Cycle2、3（Cycle length: 21 days）：Tislelizumab (IV), dose= 200mg, day=1.

Following surgical resection, high risk participants receive 200 mg Tislelizumab Q3W plus chemoradiotherapy as adjuvant therapy. Low risk participants receive 200 mg Tislelizumab Q3W plus radiotherapy as adjuvant therapy.

Neoadjuvant therapy ( 3 cycles ) ： Cycle1、2、3（Cycle length: 21 days）：Tislelizumab (IV), dose= 200mg, day=1; Cisplatin (IV), dose=75 mg/m2, or Carboplatin (IV), AUC=5, day=1; Nab-paclitaxel (IV), dose=260mg/m2, day=1.

Following surgical resection, high risk participants receive 200 mg Tislelizumab Q3W plus chemoradiotherapy as adjuvant therapy. Low risk participants receive 200 mg Tislelizumab Q3W plus radiotherapy as adjuvant therapy.

Following surgical resection, high risk participants receive chemoradiotherapy as adjuvant therapy. Low risk participants receive radiotherapy as adjuvant therapy.

Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

Carboplatin (neoadjuvant）

Carboplatin (adjuvant）

Bin Wei, Master

Yumeng Liu

Yang Wang, Master

A prospective, randomized, open-label, multicenter Phase 3 trial designed to compare the safety and efficacy of Tislelizumab combined with chemotherapy followed by surgery versus up-front surgery in resectable head and neck squamous cell carcinoma.

Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Head and Neck Squamous Cell Carcinoma (REDUCTION-I)

A Phase 3, Prospective，Multicenter, Randomized Open-Label Trial to Compare the Efficacy and Safety of Tislelizumab (BGB A317, Anti-PD1 Antibody) Combined With Chemotherapy Followed By Surgery Versus Up-Front Surgery as Treatment for Resectable Head And Neck Squamous Cell Carcinoma

Percentage of adverse events that are possibly, probably or definitely related to study treatment per Criteria for Adverse Events version 5 (CTCAE v5.0).

EFS is the time from the date of randomization to the date of first record of any of the following events: disease progression; local or distant recurrence as assessed with imaging or biopsy as indicated; or death due to any cause（Arm A versus Arm B）.

MPR is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes.

The rate of patients with complete remission (CR) or partial response (PR) evaluated by RECIST 1.1 criteria by site radiology review.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Clinically Node-negative Head and Neck Squamous Cell Carcinoma	NCT06323369	Head and Neck S...	Tislelizumab（ne... Cisplatin （neoa... Nab-paclitaxel ... Surgical resect... Cisplatin（adjuv... Tislelizumab（ad... Radiation Carboplatin（neo... Carboplatin（adj...	18 Years - 75 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Head and Neck Squamous Cell Carcinoma (REDUCTION-I)	NCT05582265	Head and Neck S...	Tislelizumab（ne... Cisplatin （neoa... Nab-paclitaxel ... Surgical resect... Cisplatin（adjuv... Tislelizumab（ad... Radiation Carboplatin (ne... Carboplatin (ad...	18 Years - 80 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Clinically Node-negative Head and Neck Squamous Cell Carcinoma	NCT06323369	Head and Neck S...	Tislelizumab（ne... Cisplatin （neoa... Nab-paclitaxel ... Surgical resect... Cisplatin（adjuv... Tislelizumab（ad... Radiation Carboplatin（neo... Carboplatin（adj...	18 Years - 75 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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