Candonilimab and ATRA Acid for Prevention of Oral Cancer Recurrence in Patients With OPL
NCT ID: NCT06728631
Last Updated: 2025-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
22 participants
INTERVENTIONAL
2020-06-30
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
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.
mixed arm
Routine follow-up or treatment methods other than those in the intervention group of this study
other treatment or observation
other treatment other than Candonilimab/ATRA or observation
Interventions
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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.
other treatment or observation
other treatment other than Candonilimab/ATRA or observation
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. History of one occurrence of invasive oral cancer/carcinoma in situ, and have undergone curative treatment.
4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1.
5. Adequate function of important organs and bone marrow:
1. Hematology parameters: absolute neutrophil count (ANC) ≥ 1.5×10\^9/L, platelet count (PLT) ≥ 100×10\^9/L, hemoglobin (HGB) ≥ 8g/dL.
2. Liver function: total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) and/or aspartate transferase (AST) ≤ 2.5×ULN.
3. Renal function: serum creatinine (Cr) ≤ 1.5×ULN.
6. Written informed consent and willingness to comply with the protocol procedures and visits.
Exclusion Criteria
2. Patients who have undergone a major surgery or have unhealed wounds, ulcers, or fractures within 4 weeks before the first dose of study treatment.
3. 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.
4. History of exposure to any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies.
5. 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.
6. Use of any investigational drug within 4 weeks before the first dose of study treatment.
7. 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).
8. Vaccination with live attenuated vaccines within 4 weeks before the first dose of study treatment or planned administration during the study.
9. 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).
10. Confirmed immunodeficiency disease.
11. History of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
12. Known allergy to any monoclonal antibody component.
13. Uncontrolled severe diseases.
14. Coexistence of other malignancies, except for:
1. Cured malignancy (e.g., papillary thyroid carcinoma).
2. Non-melanoma skin cancer or malignancy resembling melanoma with no evidence of disease recurrence after adequate treatment.
3. Carcinoma in situ with no evidence of disease recurrence after adequate treatment.
15. Pregnant or lactating patients. 5.4 Exclusion and Withdrawal Criteria.
18 Years
ALL
No
Sponsors
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
OTHER
Responsible Party
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Guopei Zhu
Dr.
Locations
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Shanghai Ninth People's Hospital
Shanghai, , China
Countries
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Other Identifiers
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2024HNRT01
Identifier Type: -
Identifier Source: org_study_id
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