Candonilimab and ATRA Acid for Prevention of Oral Cancer Recurrence in Patients With OPL

NCT06728631 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 2024HNRT01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Cavity Cancer; Premalignant Lesion

Outcome Measures

Primary Outcomes (1)

• oral-cancer free survival，OCFS

  2-year

Secondary Outcomes (4)

• clinical response rate

  2-year

• Safety Profile

  3 months

• Quality-of-Life

  1 year

• overall survival, OS

  2-year

Study Arms (2)

Intervention with Candonilimab and ATRA

EXPERIMENTAL

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.

Drug: Candonilimab and ATRA

mixed arm

OTHER

Routine follow-up or treatment methods other than those in the intervention group of this study

Other: other treatment or observation

Interventions

Candonilimab and ATRA DRUG

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.

Intervention with Candonilimab and ATRA

other treatment or observation OTHER

other treatment other than Candonilimab/ATRA or observation

mixed arm

Eligibility Criteria

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

You may qualify if:

• 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 0-1.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Ninth People's Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

Tretinoin; Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Methods; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: The mixed control group includes patients who have previously experienced at least one instance of oral cancer and are also diagnosed with oral precancerous lesions. These patients will undergo routine follow-up or treatments other than the interventions used in this study's experimental group.

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 11, 2024
• Study Start: June 30, 2020
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)