Skip to main content
OpenTrials
Completed

NCT Number: NCT04393506

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Oral Cancer Head and Neck Neoplasms Inductive Therapy Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Programmed Cell Death 1 Inhibitor Stomatognathic Diseases VEGFR2 Inhibitor

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, 200011, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Camrelizumab

Drug

Inductive therapy with Camrelizumab of 200mg, iv, qd, on day 1, 15, 29.

Other names: Humanized anti-PD-1 inhibitor

apatinib

Drug

Inductive therapy with Apatinib of 250mg, po, qd, initiating on day 1, ending on the fifth day before surgery.

Other names: VEGFR2 inhibitor

Radical surgery

Procedure

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

Post-operative radiotherapy/chemoradiotherapy

Radiation

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Inductive Camrelizumab and Apatinib for Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma: A Single-arm Phase I Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2023
First posted
May 19, 2020
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.