Neoadjuvant Sintilimab Plus Chemotherapy for cT2N0M0 Oral Squamous Cell Carcinoma

NCT07827872 | Not Yet Recruiting Phase 3

• 1 other identifier: SYSKY-2026-737-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a superiority multi-center, open-label, phase III randomized controlled trial. It will further verify the clinical value of xidili single-antibody combined with chemotherapy (albumin paclitaxel and carboplatin) in neoadjuvant treatment for operable cT2N0M0 early oral squamous cell carcinoma (Oral Squamous Cell Carcinoma, OSCC) patients in terms of improving long-term survival and pathological remission. The study subjects are patients aged 18-75 years, diagnosed with cT2N0M0 stage (8th edition AJCC staging as stage II) OSCC by pathology, with ECOG score of 0-1, good organ function, and meeting laboratory standards (ANC ≥ 1.5 × 10⁹/L, Hb \> 90g/L, CrCl ≥ 60ml/min, ALT/AST ≤ 2.5 × ULN); Exclusion criteria include previous immunotherapy with immune checkpoint inhibitors, active autoimmune diseases, poorly controlled comorbidities, high viral load infection of HBV/HCV, etc.; Patients with surgical resection conditions and signing informed consent will be enrolled. The subjects were randomly divided into two groups at a ratio of 1:1: The experimental group received neoadjuvant treatment with xidili single-antibody combined with albumin paclitaxel and carboplatin for 2-3 cycles followed by surgery (primary lesion resection + I-III region cervical lymph node dissection), while the control group received standard treatment (direct surgery). The primary endpoint of the study is the 3-year event-free survival rate (Event-Free Survival rate, EFS rate), and secondary endpoints include overall survival rate (Overall survival rate, OS rate), major pathological response rate (Major Pathological Response, MPR), complete pathological response rate (Complete Pathological Response, pCR), objective response rate (Objective Response Rate, ORR), safety analysis (Treatment-Related Adverse Event, TRAE), and postoperative lymph node positive rate (Lymph Node Positivity rate, LNP rate). The sample size was calculated based on the Log-rank test, referring to the prospective clinical baseline data of standard surgical treatment for early oral cancer, setting the 3-year EFS rate of the control group at 80%, assuming that the experimental group can be improved to 90% (HR = 0.47), setting a two-sided α = 0.05, efficacy 80%, and follow-up dropout rate 10%, a total of 300 patients (150 in each group) need to be enrolled. This study will provide high-quality evidence-based evidence for optimizing the treatment strategy for cT2N0M0 early high-risk oral squamous cell carcinoma, improving the pathological response rate and long-term recurrence-free survival.

Conditions

Head and Neck Squamous Cell Carcinoma; Oral Squamous Cell Carcinoma (OSCC); Early-stage Oral Cancer

Keywords

Neoadjuvant Immunotherapy; Sintilimab; Chemotherapy; Early-stage oral cancer; cT2N0M0; PD-1 Inhibitor

Outcome Measures

Primary Outcomes (1)

• 3-Year Event-Free Survival (EFS)

  Percentage of participants who remain alive without disease progression, local or regional recurrence, distant metastasis, or second primary malignancy at 3 years following randomization.

  3 years post-randomization

Secondary Outcomes (6)

• Pathological Complete Response (pCR) Rate

  At the time of surgery

• Major Pathological Response (MPR) Rate

  At the time of surgery

• Overall Survival (OS)

  3 years post-randomization

• Objective Response Rate (ORR)

  Prior to surgery

• Incidence of Adverse Events (AEs)

  Up to 30 days following the last dose of study treatment

Study Arms (2)

Experimental Arm: Sintilimab + Chemotherapy

EXPERIMENTAL

Patients receive neoadjuvant Sintilimab combined with chemotherapy (Nab-Paclitaxel + Carboplatin) prior to surgery, followed by standard radical surgery.

Drug: Sintilimab; Drug: Nab-Paclitaxel; Drug: Carboplatin; Procedure: Radical Surgery

Control Arm: Upfront Surgery

ACTIVE COMPARATOR

Patients receive upfront standard radical surgery without neoadjuvant therapy.

Procedure: Radical Surgery

Interventions

Sintilimab DRUG

200 mg intravenously every 3 weeks (Q3W)

Experimental Arm: Sintilimab + Chemotherapy

Nab-Paclitaxel DRUG

260 mg/m² intravenously on Day 1 of each 21-day cycle (Q3W)

Experimental Arm: Sintilimab + Chemotherapy

Carboplatin DRUG

AUC 5 intravenously on Day 1 of each 21-day cycle (Q3W).

Experimental Arm: Sintilimab + Chemotherapy

Radical Surgery PROCEDURE

Standard radical resection of oral tumor and regional lymph node dissection.

Control Arm: Upfront Surgery; Experimental Arm: Sintilimab + Chemotherapy

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed primary squamous cell carcinoma of the oral cavity.
• Clinical stage cT2N0M0 according to the AJCC 8th edition staging system.
• Age between 18 and 75 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Deemed eligible for radical surgical resection of the primary tumor and regional lymph nodes.
• Adequate organ function within 14 days prior to randomization:
• Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
• Platelets \>= 100 x 10\^9/L
• Hemoglobin \>= 9.0 g/dL
• Total bilirubin \<= 1.5 x upper limit of normal (ULN)
• AST and ALT \<= 2.5 x ULN
• Serum creatinine \<= 1.5 x ULN or creatinine clearance \>= 50 mL/min
• Voluntary written informed consent provided by the patient or legal representative.

You may not qualify if:

• Presence of regional lymph node metastasis or distant metastasis (cN+ or M1).
• Prior systemic antitumor therapy, radiotherapy, or immunotherapy for head and neck cancer.
• History of other active malignant neoplasms within the past 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ).
• Active autoimmune disease or history of severe autoimmune disease requiring systemic corticosteroids or immunosuppressive agents.
• Severe cardiovascular disease, including unstable angina, myocardial infarction within 6 months, or uncontrolled heart failure (NYHA Class III/IV).
• Active infection requiring systemic intravenous antimicrobial treatment.
• Known history of severe allergy or hypersensitivity to sintilimab, albumin-bound paclitaxel, carboplatin, or their excipients.
• Pregnant or breastfeeding women, or patients of childbearing potential unwilling to use effective contraception during the study and for 6 months after the last dose.
• Any underlying medical condition or psychiatric disorder that, in the opinion of the investigator, would jeopardize participant safety or trial compliance.

Sponsors & Collaborators

• caohaotian: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital

Guangzhou, Gyangdong, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Mouth Neoplasms

Interventions

sintilimab; 130-nm albumin-bound paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Haotian Cao, Ph.D.

CONTACT

86+19927631809; caobleat@hotmail.com

Jinsong Li, Ph.D.

CONTACT

86+13609001967; lijinsong1967@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: Chief Physician

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2032
• Study Completion (Estimated): October 1, 2032
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

CN (1)