A Bidirectional Observational Clinical Study of NAIC in the Treatment of Tumor Regression Patterns in LA-OSCC and LA-OPSCC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-11

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A prospective collection of 35 cases was conducted at Zhujiang Hospital of Southern Medical University. Patients diagnosed with locally advanced oral squamous cell carcinoma (LA-OSCC) or locally advanced oropharyngeal squamous cell carcinoma (LA-OPSCC) from April 2023 onward, who received two cycles of neoadjuvant immunochemotherapy (tislelizumab + paclitaxel + cisplatin/carboplatin) at our institution, were included. The study analyzed treatment safety, efficacy, tumor regression patterns, 2-year progression-free survival (PFS), and 5-year overall survival (OS) rates.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma

NCT00933387

Oral Cancer

COMPLETED PHASE2

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

NCT05125055

Oral Squamous Cell Carcinoma Neoadjvant Therapy Anti-PD-1 +1 more

RECRUITING PHASE2/PHASE3

Tirelizumab in Combination With Carboplatin and Albumin-binding Paclitaxel for Neoadjuvant Therapy in HNSCC

NCT05941338

Head and Neck Squamous Cell Carcinoma Oral Cancer

RECRUITING PHASE2

Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer.

NCT01919567

Carcinogenesis Oral Cancer

UNKNOWN

Real-world Analysis on the Efficacy and Safety of Neoadjuvant Therapy for Head and Neck Squamous Cell Carcinoma （neoHNSCC）

NCT06011993

Head and Neck Squamous Cell Carcinoma

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study retrospectively collected data from patients in 2023 and prospectively collected data from patients undergoing treatment at the same time. In terms of time type, it is a bidirectional study. Meanwhile, these studies are a single-arm, single-center study and belong to a case series study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Squamous Cell Carcinoma (OSCC) Oropharyngeal Squamous Cell Carcinoma (SCC)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Oral squamous cell carcinoma or oropharyngeal squamous cell carcinoma diagnosed as locally advanced (T3-4) according to the AJCC criteria
2. Their age ranged from 18 to 80 years
3. There was no history of other malignant tumors or treatment
4. Adequate blood function: white blood cell count (WBC) ≥3.5×10\^9/L, platelet count (PLT) ≥75×10\^9/L; Hemoglobin concentration (HGB) ≥90g/L
5. Adequate liver function: total bilirubin (TBIL) ≤ the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal
6. "Adequate renal function: urinary white blood cells \< 10, red blood cells \< 10, cast count \< 5 per high-power field, and creatinine (CRE) ≤ the upper limit of normal.
7. The heart, brain, lung and other vital organs function and general condition can tolerate NACI and surgical treatment
8. PS score ≤2

Exclusion Criteria

1. Presence of distant metastasis
2. Women who are pregnant or lactating
3. Patients who are unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons
4. Receiving investigational treatment in addition to other clinical studies (in the treatment phase of a clinical study)
5. Accompanied by severe uncontrolled infection or medical illness
6. Major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, cannot tolerate NACI or surgical treatment
7. There are factors affecting surgery or anesthesia, such as severe organ dysfunction
8. Long-term use of immunosuppressive agents after organ transplantation
9. Patients with a history of other malignant tumors before enrollment

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No