Evaluate the DFS of Patients With Esophageal Cancer Who Underwent Radical Operation After Regular Removal of Porphyromonas GingivalisPhase 3NCT06418945
Clinical Study on the Effect of Removal of Porphyromonas Gingivalis on Prognosis of Esophageal Cancer After Radical Surgery
A Phase 3 study testing Tinidazole oral microneedle patch in people with Evaluate the DFS of Patients With Esophageal Cancer Who Underwent Radical Operation After Regular Removal of Porphyromonas Gingivalis, run by The First Affiliated Hospital of Henan University of Science and Technology.
Trial summary
Esophagectomy is an important means of radical treatment of esophageal cancer, but due to local recurrence and metastasis, the 5-year survival rate of patients with esophageal cancer is only 20-30%. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Evaluate the DFS of Patients With Esophageal Cancer Who Underwent Radical Operation After Regular Removal of Porphyromonas Gingivalis
- What is being tested?
- Tinidazole oral microneedle patch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 31 Dec 2027
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-85 years old
- Histologically confirmed esophageal cancer
- Patients undergoing radical resection for esophageal cancer who do not require or are not eligible for radiotherapy，T1-T4N0-3M0
- ECOG：0～1
- Expected survival ≥12 weeks
- Radical surgery was performed within 28 days and met R0 criteria
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- The patient did not receive neoadjuvant radiotherapy/neoadjuvant concurrent chemoradiotherapy before surgery and no longer received adjuvant radiotherapy/adjuvant chemoradiotherapy
- If the major organs function normally, the following criteria are met: HB≥90g/L；b.ANC≥1.5×109/L；c.PLT ≥80×109/L；ALB≥30g/L；b.ALT和AST≤2.5ULN
- Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 6 months after the end of the study period
- The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up
Who cannot join
- Does not meet the above inclusion criteria
- Patients with distant visceral metastases
- Patients requiring adjuvant radiotherapy after neoadjuvant radiotherapy or radical surgery
- Allergic to tinidazole or metabolic disorder
- Patients in need of warfarin anticoagulation and those unable to abstain from alcohol
- Patients who do not tolerate ultrasonic dental cleaning
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- Pregnant or lactating women
- Patients with other malignancies within 5 years (except cured basal cell carcinoma of the skin and cervical carcinoma in situ)
- Patients with a history of psychotropic substance abuse who are unable to abstain or have mental disorders
- Patients who have participated in clinical trials of other drugs within four weeks
- Patients with concomitant diseases that, in the investigator's judgment, seriously endanger patient safety or interfere with the patient's completion of the study
- Patients with recurrent mouth ulcers or other oral diseases that affect the oral flora
- Patients with chronic infectious diseases or autoimmune diseases requiring prolonged or repeated use of antimicrobials or glucocorticoids
- The researchers did not consider it suitable for inclusion
About this study
Official title: Porphyromonas Gingivalis Elimination From Oral Improves Esophageal Cancer Patients Survival After Radical Operation
Esophagectomy is an important means of radical treatment of esophageal cancer, but due to local recurrence and metastasis, the 5-year survival rate of patients with esophageal cancer is only 20-30%. Studies have reported that about 50% of patients relapse within 1 year after surgery, and the short-term recurrence rate is high. Therefore, reducing the recurrence rate of esophageal cancer after operation is an important way to improve its prognosis. Porphyromonas gingivalis infection in ESCC tissues was significantly higher than that in paracancer tissues, and was significantly positively correlated with cancer cell differentiation, lymph node metastasis, TNM stage, and shortened survival of ESCC patients. In summary, porphyromonas gingivalis plays an important role in postoperative recurrence of esophageal cancer. Elimination of porphyromonas gingivalis can significantly reduce the recurrence rate of esophageal cancer after operation. Tinidazole is a class of nitroimidazole drugs. It has been pointed out that the pharmacological mechanism of Tinidazole is to inhibit the DNA synthesis of pathogenic bacteria, so as to eliminate bacteria in periodontal tissues and inhibit local inflammation. Based on this, we designed and fabricated a novel oral microneedle patch loaded with tinidazole. Tinidazole oral microneedle patch can effectively remove porphyromonas gingivalis and promote the repair of gingival tissue. In this study, based on the combination of mechanical removal and antibacterial treatment, a combination of ultrasonic dental cleaning and tinidazole oral composite microneedle patch was designed to completely remove porphyromonas gingivalis in oral cavity, and to evaluate the effect of removal of porphyromonas gingivalis in oral cavity on the prognosis of esophageal cancer after radical surgery.
- Being tested
- Tinidazole oral microneedle patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinidazole oral microneedle patchCombination product
Also called Ultrasonic tooth cleaning
Ultrasonic teeth cleaning: After gargling with compound chlorhexidine gargle or 3% hydrogen peroxide gargle for 1 minute, the teeth were cleaned by ultrasonic wave. After the teeth were cleaned, the wound was rinsed with 3% hydrogen peroxide to stop bleeding. Immediately after the ultrasonic cleaning, two pieces of tinidazole oral composite microneedle patch were applied to the upper and lower gums close to the inside of the first molar, especially on the tooth loss or damage, and the mouth was kept closed for 15 minutes. After the microneedle was fully degraded, the room could be left.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1:pg（-） | No intervention | The routine follow-up review after radical resection of esophageal cancer was performed according to the schedule requirements |
| Arm 2:pg（+） | Experimental | Dental cleaning combined with gum tape treatment every three months until disease progression/recurrence/death or intolerable adverse reactions occur. Receives: Combination Product: Tinidazole oral microneedle patch |
| Arm 3:pg（+） | No intervention | The routine follow-up review after radical resection of esophageal cancer was performed according to the schedule requirements |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
Disease-free survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate the DFS of Patients With Esophageal Cancer Who Underwent Radical Operation After Regular Removal of Porphyromonas GingivalisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418945
- Sponsor's protocol ID
- PGESCC001
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Porphyromonas Gingivalis Elimination From Oral Improves Esophageal Cancer Patients Survival After Radical Operation
- ClinicalTrials.gov ID
- NCT06418945
- Acronym / sponsor ID
- PGESCC001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 May 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.
Esophagectomy is an important means of radical treatment of esophageal cancer, but due to local recurrence and metastasis, the 5-year survival rate of patients with esophageal cancer is only 20-30%. Studies have reported that about 50% of patients relapse within 1 year after surgery, and the short-term recurrence rate is high. Therefore, reducing the recurrence rate of esophageal cancer after operation is an important way to improve its prognosis. Porphyromonas gingivalis infection in ESCC tissues was significantly higher than that in paracancer tissues, and was significantly positively correlated with cancer cell differentiation, lymph node metastasis, TNM stage, and shortened survival of ESCC patients. In summary, porphyromonas gingivalis plays an important role in postoperative recurrence of esophageal cancer. Elimination of porphyromonas gingivalis can significantly reduce the recurrence rate of esophageal cancer after operation. Tinidazole is a class of nitroimidazole drugs. It has been pointed out that the pharmacological mechanism of Tinidazole is to inhibit the DNA synthesis of pathogenic bacteria, so as to eliminate bacteria in periodontal tissues and inhibit local inflammation. Based on this, we designed and fabricated a novel oral microneedle patch loaded with tinidazole. Tinidazole oral microneedle patch can effectively remove porphyromonas gingivalis and promote the repair of gingival tissue. In this study, based on the combination of mechanical removal and antibacterial treatment, a combination of ultrasonic dental cleaning and tinidazole oral composite microneedle patch was designed to completely remove porphyromonas gingivalis in oral cavity, and to evaluate the effect of removal of porphyromonas gingivalis in oral cavity on the prognosis of esophageal cancer after radical surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1:pg（-） | No intervention | –The routine follow-up review after radical resection of esophageal cancer was performed according to the schedule requirements |
| Arm 2:pg（+） | Experimental | Combination Product: Tinidazole oral microneedle patchDental cleaning combined with gum tape treatment every three months until disease progression/recurrence/death or intolerable adverse reactions occur. |
| Arm 3:pg（+） | No intervention | –The routine follow-up review after radical resection of esophageal cancer was performed according to the schedule requirements |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-85 years old
- Histologically confirmed esophageal cancer
- Patients undergoing radical resection for esophageal cancer who do not require or are not eligible for radiotherapy，T1-T4N0-3M0
- ECOG：0～1
- Expected survival ≥12 weeks
Key exclusion criteria (14 listed)
- Does not meet the above inclusion criteria
- Patients with distant visceral metastases
- Patients requiring adjuvant radiotherapy after neoadjuvant radiotherapy or radical surgery
- Allergic to tinidazole or metabolic disorder
- Patients in need of warfarin anticoagulation and those unable to abstain from alcohol
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 |
|---|---|---|
| Tinidazole oral microneedle patchAlso: Ultrasonic tooth cleaningUltrasonic teeth cleaning: After gargling with compound chlorhexidine gargle or 3% hydrogen peroxide gargle for 1 minute, the teeth were cleaned by ultrasonic wave. After the teeth were cleaned, the wound was rinsed with 3% hydrogen peroxide to stop bleeding. Immediately after the ultrasonic cleaning, two pieces of tinidazole oral composite microneedle patch were applied to the upper and lower gums close to the inside of the first molar, especially on the tooth loss or damage, and the mouth was kept closed for 15 minutes. After the microneedle was fully degraded, the room could be left. | Combination product | Arm 2:pg（+） |
Primary outcome
DFS
Time frame: 5 years
Disease-free survival
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 17 May 2024.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tinidazole oral microneedle patch in people with Evaluate the DFS of Patients With Esophageal Cancer Who Underwent Radical Operation After Regular Removal of Porphyromonas Gingivalis, run by The First Affiliated Hospital of Henan University of Science and Technology.
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 10 inclusion and 14 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: opening soon, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
DFS (time frame: 5 years). 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 17 May 2024.