Sintilimab to Prevent High-risk Oral Premalignant Lesions Cancerization

NCT04065737 | Unknown Phase 2

• 1 other identifier: 2019HNRT01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Cavity Cancer; Mouth Neoplasm; Precancerous Conditions

Keywords

high-risk oral pre-malignant lesions; history of invasive oral cancer; sintilimab

Outcome Measures

Primary Outcomes (1)

• oral cancer incidence rate

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

  2 years

Secondary Outcomes (7)

• clinical response rate of oral premalignant lesions

  2 years

• pathologically response rate of oral premalignant lesions

  2 years

• Duration of Response (DoR) of oral premalignant lesions

  2 years

• 2 year oral-cancer-free survival

  2 years

• Treatment-related Adverse Events (AEs)

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

Study Arms (1)

Sintilimab

EXPERIMENTAL

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

Interventions

Sintilimab DRUG

Sintilimab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells. other name: IBI308

Also known as: IBI308

Sintilimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai ninth people's hospital

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Conditions

Mouth Neoplasms; Precancerous Conditions

Interventions

sintilimab

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Guopei Zhu

CONTACT

+8602164175590; antica@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 22, 2019
• Study Start: August 15, 2019
• Primary Completion: July 15, 2022
• Study Completion: December 30, 2022
• Last Updated: August 22, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)