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Changes of oral and intestinal microbiome before and after preoperative induction chemotherapy in patients with oral squamous cell carcinoma and its prediction of chemotherapy efficacy

Changes of oral and intestinal microbiome before and after preoperative induction chemotherapy in patients with oral squamous cell carcinoma and its prediction of chemotherapy efficacy

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200062466
Enrollment
Unknown
Registered
2022-08-08
Start date
2022-08-08
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral squamous cell carcinoma

Interventions

Experiment Group:TPF induction chemotherapy

Sponsors

Southern Medical University Shenzhen Stomatology Hospital (Pingshan)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years with primary oral cancer (tongue, buccal mucosa, upper and lower gums, floor of mouth, and hard palate), regardless of gender; 2. Patients with pathologically confirmed oral squamous cell carcinoma: (1) No distant metastasis was clinically diagnosed by chest film, abdominal B-ultrasound, CT, or MR (PET-CT if necessary); (2) Newly diagnosed, stage II-IVa oral squamous cell carcinoma (according to the tight edition standard of AJCC staging manual for OSCC); (3) Induction chemotherapy and surgical treatment are feasible after evaluation and confirmation by specialized surgeon, anesthesiologist, and oncologist; (4) Willing to accept preoperative induction chemotherapy and surgical treatment; 3. KPS score >= 60, Zps score = 1.5*10^9/L, Platelet (PLT) >= 100*10^9/L, Hemoglobin >= 9 g/dl; (2) Liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) = 2.8 g/dl; (4) Renal function: creatinine clearance (CCR) > 60 ml/min; (5) Coagulation function: international normalized ratio (INR) <= 1.5; Partial thromboplastin time (APTT) <= 1.5*ULN; 5. Willing to join the study, sign informed consent, able to abide relevant procedures specified in the protocol.

Exclusion criteria

Exclusion criteria: 1. Have previously received anti-tumor treatment or have other tumor diseases at the same time; 2. Have any active autoimmune disease or has a history of autoimmune disease, hormone or steroid medication; Long term (> 1 year) history of taking psychotropic drugs; Long term (> 3 months) irregular antibiotic use history; Long term (> 1 month) use history of antibacterial mouthwash; Taking probiotics and prebiotics in recent 3 months; Gastrointestinal diseases in recent 3 months; History of acute infection in recent 2 weeks; 3. Patients who cannot guarantee to complete the necessary treatment plan and follow-up; 4. Other situations in which researchers think it is not suitable to be included in the group.

Design outcomes

Primary

MeasureTime frame
Species of bacteria;Clinical tumor response;

Countries

China

Contacts

Public ContactWei Wu

Tianjin Medical University General Hospital

wuwei19672002@sohu.com+86 13920000528

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026