A Phase II Open-label, Single Arm Study to Evaluate the Efficacy of Sintilimab(IBI 308) to Prevent High-risk Oral Premalignant Lesions Cancerization

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 site in 1 country29 target enrollmentAugust 15, 2019

ConditionsOral Cavity Cancer Mouth Neoplasm Precancerous Conditions

InterventionsSintilimab

DrugsSintilimab

Overview

Phase: Phase 2
Intervention: Sintilimab
Conditions: Oral Cavity Cancer
Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Enrollment: 29
Locations: 1
Primary Endpoint: oral cancer incidence rate
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

August 15, 2019

End Date

December 30, 2022

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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-
•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.

Exclusion Criteria

•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

Arms & Interventions

Sintilimab

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

Intervention: Sintilimab

Outcomes

Primary Outcomes

oral cancer incidence rate

Time Frame: 2 years

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

Secondary Outcomes

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)
Treatment-related Adverse Events (AEs)(From the date of randomization to 90 days after last dose of study treatment)
2 year oral-cancer-free survival(2 years)
quality of life(QOL)(2 years)
Overall survival (OS)(2 year)