Oral Cavity CancerPhase 2NCT06728631
Candonilimab and ATRA Acid for Prevention of Oral Cancer Recurrence in Patients With OPL
A Phase 2 study testing Candonilimab and ATRA and other treatment or observation in people with Oral Cavity Cancer and Premalignant Lesion, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cavity Cancer, Premalignant Lesion
- What is being tested?
- Candonilimab and ATRA and other treatment or observation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2020to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Candonilimab Combined With All-trans Retinoic Acid for Prevention of Oral Cancer Recurrence in Patients With High-risk Oral Precancerous Lesions.
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
- Being tested
- Candonilimab and ATRA, other treatment or observation
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candonilimab and ATRADrug
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 observationOther
other treatment other than Candonilimab/ATRA or observation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Candonilimab and ATRA |
| mixed arm | Other | Routine follow-up or treatment methods other than those in the intervention group of this study Receives: Other: other treatment or observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral-cancer free survival，OCFS
Measured: 2-year
Secondary outcomes (4)
clinical response rate
clinical response rate of oral premalignant lesions
Measured: 2-year
Safety Profile
Adverse Events of The Treatment
Measured: 3 months
Quality-of-Life
EORTC QLQ-C30
Measured: 1 year
overall survival, OS
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start30 Jun 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Cavity CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guopei Zhu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728631
- Sponsor's protocol ID
- 2024HNRT01
- Status last verified
- Feb 2025
- First submitted
- 8 Dec 2024
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Candonilimab Combined With All-trans Retinoic Acid for Prevention of Oral Cancer Recurrence in Patients With High-risk Oral Precancerous Lesions.
- ClinicalTrials.gov ID
- NCT06728631
- Acronym / sponsor ID
- 2024HNRT01
- Conditions
- Oral Cavity Cancer, Premalignant Lesion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention with Candonilimab and ATRA | Experimental | Drug: Candonilimab and ATRACandonilimab 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 | Other | Other: other treatment or observationRoutine follow-up or treatment methods other than those in the intervention group of this study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Candonilimab and ATRACandonilimab 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 | Intervention with Candonilimab and ATRA |
| other treatment or observationother treatment other than Candonilimab/ATRA or observation | Other | mixed arm |
Primary outcome
oral-cancer free survival，OCFS
Time frame: 2-year
4 secondary outcomes
clinical response rate
Time frame: 2-year
Safety Profile
Time frame: 3 months
Quality-of-Life
Time frame: 1 year
overall survival, OS
Time frame: 2-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Candonilimab and ATRA and other treatment or observation in people with Oral Cavity Cancer and Premalignant Lesion, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral-cancer free survival，OCFS (time frame: 2-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.