A Study of Candonilimab Combined With All-trans Retinoic Acid for Prevention of Oral Cancer Recurrence in Patients With High-risk Oral Precancerous Lesions.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- oral-cancer free survival，OCFS
研究概览
简要总结
The aim of this study is to involve high-risk patients with a history of malignant transformation in oral potentially malignant disorders. We will use a combination of Cardunil and all-trans retinoic acid for intervention. The effectiveness and safety of the combination therapy will be evaluated in the treatment of high-risk oral potentially malignant disorders, including the prevention of oral cancer recurrence and treatment of oral potentially malignant disorders. The findings of this study will provide evidence for tertiary prevention of oral cancer and the treatment of oral potentially malignant disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥18 years old.
- •Patients with a history of oral potentially malignant disorders and still presenting any of the following potential malignant manifestations upon oral examination: (1) oral mucosal leukoplakia, (2) oral mucosal morphological changes (thickening, proliferation, etc.), (3) gingival atrophy, dark red gums, (4) oral mucosal ulcers, (5) white tongue coating changes, (6) oral mucosal erythema, blood blisters, etc.
- •History of one occurrence of invasive oral cancer/carcinoma in situ, and have undergone curative treatment.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-
- •Adequate function of important organs and bone marrow:
- •Hematology parameters: absolute neutrophil count (ANC) ≥ 1.5×10^9/L, platelet count (PLT) ≥ 100×10^9/L, hemoglobin (HGB) ≥ 8g/dL.
- •Liver function: total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) and/or aspartate transferase (AST) ≤ 2.5×ULN.
- •Renal function: serum creatinine (Cr) ≤ 1.5×ULN.
- •Written informed consent and willingness to comply with the protocol procedures and visits.
排除标准
- •Patients who require adjuvant treatment such as radiation therapy or chemotherapy according to the assessment based on the malignant tumor treatment guidelines after the most recent oral cancer surgery (at least meeting any of the following criteria: T3-4, N2-3, DOI > 5mm, positive surgical margins/ < 5mm).
- •Patients who have undergone a major surgery or have unhealed wounds, ulcers, or fractures within 4 weeks before the first dose of study treatment.
- •Patients who received the last dose of radiotherapy or last dose of anti-tumor treatment (chemotherapy, targeted therapy, or tumor embolization, etc.) within 4 weeks before the first dose of study treatment.
- •History of exposure to any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies.
- •Concurrent participation in another interventional clinical study, unless participating in an observational (non-interventional) clinical study or in the follow-up phase of an interventional study.
- •Use of any investigational drug within 4 weeks before the first dose of study treatment.
- •Use of immunosuppressive medication within 4 weeks before the first dose of study treatment, excluding intranasal, inhaled, or topical corticosteroids or systemic corticosteroids at physiologic doses (≤ 10 mg/day prednisone or equivalent dose of other corticosteroids).
- •Vaccination with live attenuated vaccines within 4 weeks before the first dose of study treatment or planned administration during the study.
- •Active, known, or suspected autoimmune diseases or medical history of such diseases within the past 2 years (excluding vitiligo, psoriasis, alopecia, or Grave's disease that do not require systemic treatment within the past 2 years, well-controlled hypothyroidism requiring thyroid hormone replacement, and type 1 diabetes mellitus requiring insulin replacement therapy).
- •Confirmed immunodeficiency disease.
- •History of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- •Known allergy to any monoclonal antibody component.
- •Uncontrolled severe diseases.
- •Coexistence of other malignancies, except for:
- •Cured malignancy (e.g., papillary thyroid carcinoma).
- •Non-melanoma skin cancer or malignancy resembling melanoma with no evidence of disease recurrence after adequate treatment.
- •Carcinoma in situ with no evidence of disease recurrence after adequate treatment.
- •Pregnant or lactating patients. 5.4 Exclusion and Withdrawal Criteria.
研究组 & 干预措施
Intervention with Candonilimab and ATRA
Candonilimab at a dose of 6mg/kg IV Q3W will be administered until a maximum treatment duration of 1 year. All-trans retinoic acid will be administered at a dose of 25mg/m² twice daily on days 1-14, with a treatment cycle of 21 days, until a maximum treatment duration of 6 months, or until the occurrence of oral cancer or other malignancies, death, intolerable toxicity, withdrawal of informed consent, or any other reasons specified in the protocol.
干预措施: Candonilimab and ATRA (Drug)
mixed arm
Routine follow-up or treatment methods other than those in the intervention group of this study
干预措施: other treatment or observation (Other)
结局指标
主要结局
oral-cancer free survival，OCFS
时间窗: 2-year
次要结局
- clinical response rate(2-year)
- Safety Profile(3 months)
- Quality-of-Life(1 year)
- overall survival, OS(2-year)
研究者
Guopei Zhu
Dr.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University