Inductive Camrelizumab & Apatinib for Patients With Locally Advanced &

Status Completed

Clinical Trial Summary

In patients with locally advanced oral squamous cell carcinoma (OSCC), due to the large tumor burden and neck lymph node metastasis, comprehensive treatment is recommended, including surgery, radiotherapy, chemotherapy and others. Pre-operative inductive therapy can reduce tumor volume, increase organ retention rate, and reduce distant metastasis rate. Vascular endothelial growth factor (VEGF) receptor in head and neck squamous cell carcinoma is over-expressed and associated with disease invasion and poor prognosis. The use of targeted therapy against VEGF can not only inhibit tumor neovascularization, but also make the effectiveness of chemotherapeutic agents. VEGF and VEGFR are closely related to immune escape. Tumor growth requires new blood vessels to supply nutrients and oxygen, and VEGF can stimulate neovascularization. However, tumor neovascularization is often abnormal and distorted, which prevents immune active substances from reaching the tumor site. After tumor hypoxia, high expression of VEGF will induce tumor cells to express programmed cell death protein-1 (PD-1), which further leads to immune escape. Targeted drugs against angiogenesis can relieve immunosuppression to a certain extent, and theoretically have a synergistic effect with anti-PD-1 immunotherapy. The innovation of this study is the combination of immune checkpoint inhibitor, Camrelizumab, and targeted drug against VEGFR, Apatinib, as an inductive therapy to treat the patients with locally advanced OSCC, followed with radical surgery and post-operative radiotherapy/chemoradiotherapy, the major pathologic response and safety will be evaluated as the primary surrogate endpoints, the 2-year survival rate and local recurrence rate will be the second endpoints.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Carcinoma, Squamous Cell
Inductive Therapy
Mouth Neoplasms
Oral Cancer
Programmed Cell Death 1 Inhibitor
Squamous Cell Carcinoma of Head and Neck
VEGFR2 Inhibitor

Clinical Trial Details

NCT number	NCT04393506
Study type	Interventional
Source	Shanghai Jiao Tong University School of Medicine
Contact
Status	Completed
Phase	Phase 1
Start date	April 23, 2020
Completion date	November 10, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06031337` - Salivary Expression of SOX7 in Oral Squamous Cell Carcinoma: Diagnostic Accuracy Study
Completed	`NCT00158678` - IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC	Phase 3
Completed	`NCT00933387` - A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma	Phase 2
Enrolling by invitation	`NCT05030597` - Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma	N/A
Completed	`NCT03682562` - Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions
Recruiting	`NCT03684707` - Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions	Phase 4
Recruiting	`NCT06130332` - Neoadjuvant Tirellizumab Combined With Chemotherapy for Early Oral Squamous Cell Carcinoma(HNC-SYSU-004)	Phase 2
Recruiting	`NCT04372914` - Prevention of Oral DNA Damage by Black Raspberries	N/A
Active, not recruiting	`NCT03529422` - Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN	Phase 2
Recruiting	`NCT03686020` - Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study)
Not yet recruiting	`NCT06060288` - Diagnostic Accuracy of Mobile Phone Imaging Compared to Conventional Clinical Examination for Oral Cancer Screening
Withdrawn	`NCT00951470` - Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema	N/A
Completed	`NCT00964977` - Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis.	Phase 3
Completed	`NCT01418118` - Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery	Phase 4
Active, not recruiting	`NCT00232960` - Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Oral and Oropharyngeal SCC	N/A
Recruiting	`NCT05429099` - Mandibular Reconstruction Preplanning (ViPMR)	Phase 2/Phase 3
Completed	`NCT04614896` - Use of Ultrasound for Measuring Size of Oral Tongue Cancers	N/A
Recruiting	`NCT03685409` - Cancer Chemoprevention by Metformin Hydrochloride in Oral Potentially Malignant Lesions	Phase 3
Completed	`NCT00402779` - Erlotinib Prevention of Oral Cancer (EPOC)	Phase 3
Recruiting	`NCT05153733` - Improved Implant for Reconstruction Purposes After Mandibular Resection	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Inductive Camrelizumab and Apatinib for Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms