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
|Condition or disease||Intervention/treatment||Phase|
|Oral Cavity Cancer Mouth Neoplasm Precancerous Conditions||Drug: Sintilimab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Injection; dosage form: 10ml: 100mg; frequency: 200mgQ3W; duration: 8cycles (6 months) or randomization to the date of the first documented oral cancer incidence
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
- oral cancer incidence rate [ Time Frame: 2 years ]The proportion of patients who has been diagnosed with oral cavity cancer
- 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
- 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
- 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.
- 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
- 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
- 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.
- quality of life(QOL) [ Time Frame: 2 years ]EORTC QLQ-C30 questionnaires
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
|Contact: Guopei Zhufirstname.lastname@example.org|
|Shanghai ninth people's hospital|
|Shanghai, Shanghai, China, 200011|