Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04393506
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Lai-ping Zhong, Shanghai Jiao Tong University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Oral Cancer VEGFR2 Inhibitor Programmed Cell Death 1 Inhibitor Inductive Therapy Drug: Camrelizumab Drug: Apatinib Procedure: Radical surgery Radiation: Post-operative radiotherapy/chemoradiotherapy Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inductive Camrelizumab and Apatinib for Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma: A Single-arm Phase I Trial
Actual Study Start Date : April 23, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2023


Arm Intervention/treatment
Inductive therapy
Inductive therapy with Camrelizumab and Apatinib, followed by radical surgery and post-operative radiotherapy/chemoradiotherapy.
Drug: Camrelizumab
Inductive therapy with Camrelizumab of 200mg, iv, qd, on day 1, 15, 29.
Other Name: Humanized anti-PD-1 inhibitor

Drug: Apatinib
Inductive therapy with Apatinib of 250mg, po, qd, initiating on day 1, ending on the fifth day before surgery.
Other Name: VEGFR2 inhibitor

Procedure: Radical surgery
Radical surgery will be performed on the 42th-45th after initiation of inductive therapy

Radiation: Post-operative radiotherapy/chemoradiotherapy
Post-operative radiotherapy/chemoradiotherapy will be performed within 1.5 months after radical surgery, depending on the post-operative pathologic diagnosis.




Primary Outcome Measures :
  1. Major pathologic response [ Time Frame: One year ]
    Major pathologic response is based on the pathological examination on the post-operative specimens after inductive therapy.


Secondary Outcome Measures :
  1. 2-year overall survival [ Time Frame: Two years ]
    The overall survival time refers to the time from initiating inductive therapy to death due to any cause.

  2. 2-year tumor recurrence rate [ Time Frame: Two years ]
    The tumor recurrence rate is calculated using the number of patients with tumor recurrence divided by the total number of patients.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eastern cooperative oncology group performance status (ECOG PS) score: 0-2 points
  • Pathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheeks, mouth floor, hard palate, posterior molar region)
  • Clinical stage of III/IVA (AJCC 2018)
  • Blood routine: white blood cells> 3,000/mm3, hemoglobin> 8g/L, platelets> 80,000/mm3
  • Liver function: Alanine Transaminase/Aspartate Transaminase <2.5 times the upper limit of normal, bilirubin <1.5 times the upper limit of normal
  • Renal function: serum creatinine <1.5 times the upper limit of normal
  • Sign the informed consent

Exclusion Criteria:

  • There are still unresolved toxic reactions above CTCAE level 2 caused by previous anti-cancer treatment
  • Obvious cardiovascular abnormalities [such as myocardial infarction, superior vena cava syndrome, heart disease of grade 2 or higher diagnosed according to the classification criteria of the New York Heart Association (NYHA) 3 months before enrollment]
  • Active severe clinical infection (> CTCAE 5.0 version 2 infection)
  • Difficult to control hypertension (systolic blood pressure> 150 mmHg and / or diastolic blood pressure> 90 mmHg) or cardiovascular disease with clinical significance (such as activity)-such as cerebrovascular accident (≤ 6 months before randomization), myocardial infarction (≤6 months before randomization), unstable angina, New York Cardiology Society (NYHA Appendix 5) congestive heart failure grade II or above, or severe arrhythmia that cannot be controlled with drugs or has potential impact on experimental treatment
  • Women during pregnancy or lactation
  • Participated in other clinical studies within 30 days before enrollment
  • Other circumstances that the investigator thinks are not suitable for participating in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393506


Contacts
Layout table for location contacts
Contact: Ying Liu, Master 23271699-5160 allyliuying@hotmail.com

Locations
Layout table for location information
China, Shanghai
Shanghai Ninth People's Hospital Recruiting
Shanghai, Shanghai, China, 200011
Contact: Ying Liu, Master    23271699 ext 5160    allyliuying@hotmail.com   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Lai-ping Zhong, PHD Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
  Study Documents (Full-Text)

Documents provided by Lai-ping Zhong, Shanghai Jiao Tong University School of Medicine:
Informed Consent Form  [PDF] January 8, 2020

Layout table for additonal information
Responsible Party: Lai-ping Zhong, Principal Investigator, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT04393506    
Other Study ID Numbers: Icemelting trial
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Squamous Cell
Mouth Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action