Clinical trial · Interventional

Clinical Study on the Effect of Removal of Porphyromonas Gingivalis on Prognosis of Esophageal Cancer After Radical Surgery

Porphyromonas Gingivalis Elimination From Oral Improves Esophageal Cancer Patients Survival After Radical Operation

NCT06418945CI-TRIAL-00077274not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Evaluate the DFS of Patients With Esophageal Cancer Who Underwent Radical Operation After Regular Removal of Porphyromonas Gingivalis	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Tinidazole oral microneedle patch	Combination Product	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

type
NO_INTERVENTION
label
Arm 1:pg（-）
description
The routine follow-up review after radical resection of esophageal cancer was performed according to the schedule requirements
type
EXPERIMENTAL
label
Arm 2:pg（+）
description
Dental cleaning combined with gum tape treatment every three months until disease progression/recurrence/death or intolerable adverse reactions occur.
interventionNames
1. Combination Product: Tinidazole oral microneedle patch
type
NO_INTERVENTION
label
Arm 3:pg（+）
description
The routine follow-up review after radical resection of esophageal cancer was performed according to the schedule requirements

Primary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 85 Years

Show eligibility criteria text

Inclusion Criteria:

1. Age 18-85 years old
2. Histologically confirmed esophageal cancer
3. Patients undergoing radical resection for esophageal cancer who do not require or are not eligible for radiotherapy，T1-T4N0-3M0
4. ECOG：0～1
5. Expected survival ≥12 weeks
6. Radical surgery was performed within 28 days and met R0 criteria
7. The patient did not receive neoadjuvant radiotherapy/neoadjuvant concurrent chemoradiotherapy before surgery and no longer received adjuvant radiotherapy/adjuvant chemoradiotherapy
8. 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
9. 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
10. The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up

Exclusion Criteria:

1. Does not meet the above inclusion criteria
2. Patients with distant visceral metastases
3. Patients requiring adjuvant radiotherapy after neoadjuvant radiotherapy or radical surgery
4. Allergic to tinidazole or metabolic disorder
5. Patients in need of warfarin anticoagulation and those unable to abstain from alcohol
6. Patients who do not tolerate ultrasonic dental cleaning
7. Pregnant or lactating women
8. Patients with other malignancies within 5 years (except cured basal cell carcinoma of the skin and cervical carcinoma in situ)
9. Patients with a history of psychotropic substance abuse who are unable to abstain or have mental disorders
10. Patients who have participated in clinical trials of other drugs within four weeks
11. Patients with concomitant diseases that, in the investigator's judgment, seriously endanger patient safety or interfere with the patient's completion of the study
12. Patients with recurrent mouth ulcers or other oral diseases that affect the oral flora
13. Patients with chronic infectious diseases or autoimmune diseases requiring prolonged or repeated use of antimicrobials or glucocorticoids
14. The researchers did not consider it suitable for inclusion

References

Publications (0)

Data not yet available

No reference posted for this study.