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Oral Cavity CancerPhase 2STOPNCT04065737

Sintilimab to Prevent High-risk Oral Premalignant Lesions Cancerization

A Phase 2 study testing Sintilimab in people with Oral Cavity Cancer and Mouth Neoplasm, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sintilimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteChina
Study dates
15 Aug 2019to 30 Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18
  • 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.
  • 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.
  • Eastern Cooperative Oncology Group Performance Status (ECOG) performance scale: 0-1.
  • 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.
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  • 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.
  • 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.
  • 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.
  • 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.
  • Voluntarily signed written informed consent form, willing and able to comply with scheduled visits and other requirements of the study.

Who cannot join

  • Should receive subsequent adjuvant therapy (such as radiotherapy, chemotherapy, immunotherapy)
  • 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.
  • 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.
  • Prior therapy with anti-PD-1,anti-PD-L1,anti-CTLA4 antibody.
  • Currently participating in interventional clinical research treatment, or receiving other research medications within 4 weeks prior to the first dose or used research equipment
  • Received any investigational agent within 4 weeks of the first dose of study treatment.
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  • 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.
  • Received attenuated live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during the study period.
  • 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.
  • Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation
  • Known allergic or hypersensitive to docetaxel, any monoclonal antibody or any other components used in their preparation.
  • 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
  • Known history of, or any evidence of active, non-infectious pneumonitis.
  • Other primary malignancy, with the exception of the skin or squamous cell carcinoma of the skin or in situ cervical cancer.
  • Women who are pregnant or lactating

Trial locations and contacts

1 site in 1 country.

Guopei Zhu contact

+8602164175590

antica@gmail.com

China1 site

  • Shanghai ninth people's hospital

    Shanghai, Shanghai Municipality, 200011

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Sintilimab
Keywords
high-risk oral pre-malignant lesions, history of invasive oral cancer, sintilimab
Medical subject headings
Mouth Neoplasms, Precancerous Conditions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SintilimabDrug

    Also called IBI308

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

    other name: IBI308

Study groups in NCT04065737
Study groupRoleWhat they receive
SintilimabExperimentalInjection; dosage form: 10ml: 100mg; frequency: 200mgQ3W; duration: 8cycles (6 months) or randomization to the date of the first documented oral cancer incidence
Receives: Drug: Sintilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. oral cancer incidence rate

    The proportion of patients who has been diagnosed with oral cavity cancer

    Measured: 2 years

Secondary outcomes (7)

  1. clinical response rate of oral premalignant lesions

    The proportion of patients whose oral premalignant lesions experienced a Complete Response or a Partial Response

    Measured: 2 years

  2. pathologically response rate of oral premalignant lesions

    The proportion of patients whose oral premalignant lesions experienced a locally complete response or decrease of histopathological grade

    Measured: 2 years

  3. Duration of Response (DoR) of oral premalignant lesions

    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.

    Measured: 2 years

  4. 2 year oral-cancer-free survival

    time from randomization to the development of histologically confirmed oral cancer or death of any cause, whichever occurs first

    Measured: 2 years

  5. Treatment-related Adverse Events (AEs)

    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

    Measured: From the date of randomization to 90 days after last dose of study treatment

  6. Overall survival (OS)

    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.

    Measured: 2 year

  7. quality of life(QOL)

    EORTC QLQ-C30 questionnaires

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2019
  2. Study start15 Aug 2019 (estimated)
  3. Primary completion15 Jul 2022 (estimated)
  4. Study completion30 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04065737
Sponsor's protocol ID
2019HNRT01
Acronym
STOP
Status last verified
Jul 2019
First submitted
5 Aug 2019
Last updated
22 Aug 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sintilimab in people with Oral Cavity Cancer and Mouth Neoplasm, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Guopei Zhu (+8602164175590, antica@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

oral cancer incidence rate (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04065737.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.

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