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Sintilimab to Prevent High-risk Oral Premalignant Lesions Cancerization (STOP)

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: NCT04065737
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief Summary:
This is a non-randomized, phase II, open-label study. The goal of this clinical research study is to investigate how well sintilimab works in preventing high-risk oral premalignant lesions cancerization.

Condition or disease Intervention/treatment Phase
Oral Cavity Cancer Mouth Neoplasm Precancerous Conditions Drug: Sintilimab Phase 2

Detailed Description:

this study is a non-randomized, phase II, open-label study. Phase II clinical trials test the safety and effectiveness of an investigational drug or combination of drugs to learn whether it works in preventing or treating a disease.

the purpose of this study is to evaluate the effectiveness of sintilimab in preventing the onset of oral cancer in patients with high-risk oral premalignant lesions, who had oral cancer at least once before.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II Open-label, Single Arm Study to Evaluate the Efficacy of Sintilimab(IBI 308) to Prevent High-risk Oral Premalignant Lesions Cancerization
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : July 15, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

Arm Intervention/treatment
Experimental: Sintilimab
Injection; dosage form: 10ml: 100mg; frequency: 200mgQ3W; duration: 8cycles (6 months) or randomization to the date of the first documented oral cancer incidence
Drug: Sintilimab

Sintilimab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells.

other name: IBI308

Other Name: IBI308




Primary Outcome Measures :
  1. oral cancer incidence rate [ Time Frame: 2 years ]
    The proportion of patients who has been diagnosed with oral cavity cancer


Secondary Outcome Measures :
  1. clinical response rate of oral premalignant lesions [ Time Frame: 2 years ]
    The proportion of patients whose oral premalignant lesions experienced a Complete Response or a Partial Response

  2. pathologically response rate of oral premalignant lesions [ Time Frame: 2 years ]
    The proportion of patients whose oral premalignant lesions experienced a locally complete response or decrease of histopathological grade

  3. Duration of Response (DoR) of oral premalignant lesions [ Time Frame: 2 years ]
    the time from the date for first documented response of complete response (CR) or partial response (PR) until the date for the first documented response of progressive disease (PD), incidence of oral cancer or death in the absence of progression.

  4. 2 year oral-cancer-free survival [ Time Frame: 2 years ]
    time from randomization to the development of histologically confirmed oral cancer or death of any cause, whichever occurs first

  5. Treatment-related Adverse Events (AEs) [ Time Frame: From the date of randomization to 90 days after last dose of study treatment ]
    The grade of AEs and the number of patients with AEs are assessed by the investigator based on CTCAE v4.0 from the date of randomization to 90 days after last dose of study treatment

  6. Overall survival (OS) [ Time Frame: 2 year ]
    OS (per RECIST 1.1 as assessed by the investigator) is defined as the time from the date of randomisation until death due to any cause.

  7. quality of life(QOL) [ Time Frame: 2 years ]
    EORTC QLQ-C30 questionnaires



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18
  2. Histological evidence of oral premalignant lesions (such as leukoplakia and/or erythroplakia). A history of invasive oral cancer or oral cancer in situ, which was histologically confirmed.
  3. With at least on high-risk profiles: a. have LOH at 3p14 and/or 9p21; b. pathologically diagnosis with severe dysplasia; c. size of lesions >200mm².
  4. Eastern Cooperative Oncology Group Performance Status (ECOG) performance scale: 0-1.
  5. Adequate organ and bone marrow function:

    • CBC: absolute neutrophil count (ANC) ≥ 1.5 × 10^9 / L; platelet count (PLT) ≥ 100 × 10^9 / L; hemoglobin content (HGB) ≥ 9.0 g / dL.
    • Liver function: serum total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.
    • Renal function: serum creatinine (Cr) ≤ 1.5 × ULN.
  6. Female subject of childbearing potential should have a negative urine or serum pregnancy test < 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  7. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of study therapy through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses > 1 year.
  8. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of the study therapy.
  9. Voluntarily signed written informed consent form, willing and able to comply with scheduled visits and other requirements of the study.

Exclusion Criteria:

  1. Should receive subsequent adjuvant therapy (such as radiotherapy, chemotherapy, immunotherapy)
  2. Received major surgery (such as craniotomy, thoracotomy or laparotomy) within 4 weeks of the first dose of study drugs or open wound, ulcer or fracture.
  3. Received any anti-tumor therapy (chemotherapy, targeted therapy, tumor immunotherapy or arterial embolization) or radiotherapy within 4 weeks of the first dose of study treatment.
  4. Prior therapy with anti-PD-1,anti-PD-L1,anti-CTLA4 antibody.
  5. Currently participating in interventional clinical research treatment, or receiving other research medications within 4 weeks prior to the first dose or used research equipment
  6. Received any investigational agent within 4 weeks of the first dose of study treatment.
  7. Received radiotherapy within 4 weeks of the first dose of study treatment. Received systemic treatment with high-dose corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive drugs within 4 weeks of first dose. Inhaled or topical steroids and adrenal replacement steroid are permitted in the absence of active autoimmune disease.
  8. Received attenuated live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during the study period.
  9. Subjects with active, known or suspected autoimmune disease such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis. Subjects with cured childhood asthma, type I diabetes mellitus and hypothyroidism only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment.
  10. Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation
  11. Known allergic or hypersensitive to docetaxel, any monoclonal antibody or any other components used in their preparation.
  12. Uncontrolled concomitant disease, including but not limited to :

    • Active or poorly controlled severe infection
    • Human Immunodeficiency Virus (HIV) infection (HIV antibody positive)
    • Known acute or chronic active hepatitis B (HBV DNA positive) infection or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive) infection
    • Active tuberculosis
    • Symptomatic congestive heart failure (New York Heart Association grade III-IV) or symptomatic, poorly controlled arrhythmia
    • Uncontrolled hypertension (SBP ≥ 160mmHg or DBP ≥ 100mmHg)
    • Prior arterial thromboembolism event, including myocardial infarction, unstable angina, stroke, and transient ischemic attack, within 6 months of enrollment
  13. Known history of, or any evidence of active, non-infectious pneumonitis.
  14. Other primary malignancy, with the exception of the skin or squamous cell carcinoma of the skin or in situ cervical cancer.
  15. Women who are pregnant or lactating

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): NCT04065737


Contacts
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Contact: Guopei Zhu +8602164175590 antica@gmail.com

Locations
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China, Shanghai
Shanghai ninth people's hospital
Shanghai, Shanghai, China, 200011
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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Responsible Party: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT04065737    
Other Study ID Numbers: 2019HNRT01
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University:
high-risk oral pre-malignant lesions
history of invasive oral cancer
sintilimab
Additional relevant MeSH terms:
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Precancerous Conditions
Mouth Neoplasms
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases