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Randomized Controlled Clinical Study with Traditional Chinese Medicine Treatment on preventing the recurrence and metastasis of Advanced Oral Cavity Carcinomas after radical operation

Randomized Controlled Clinical Study with Traditional Chinese Medicine Treatment on preventing the recurrence and metastasis of Advanced Oral Cavity Carcinomas after radical operation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17014195
Enrollment
Unknown
Registered
2017-12-28
Start date
2018-01-01
Completion date
Unknown
Last updated
2018-01-08

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

Conditions

Advanced Oral Cavity Carcinoma

Interventions

Group A:Benifiting Qi and yin,resolving detoxication granule
Group B:Radiotherapy

Sponsors

Shanghai Ninth People's Hospital affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients with histologically confirmed OSCC (originating in oral cavity); (2) Patients were required to have a resectable lesion, in the opinion of treating surgeons, with clinical stage ? or IVA disease according to Union for International Cancer Control; (3) TCM syndrome differentiation is Qi deficiency syndrome, yin deficiency syndrome or Qi and Yin deficiency syndrome; (4) aged 18-75 years old; (5) Eastern Cooperative OncologyGroup (ECOG) PS of two or less; (6) normal hematological function with total neutrophil count> 1.5 x 10^9/L, platelets count > 100 x 10^9/L , Lhemoglobin > 100 mg/dl and normal liver functionand kidney function; (7) patients compliance is good, and patients can understand the situation of this study and sign informed consent; (8) There were no previous chemotherapy, radiotherapy or target therapy, and no head and neck surgery was performed.

Exclusion criteria

Exclusion criteria: (1) expected lifetime < 6 months; (2) patients with other malignant tumors; (3) patients with intentional liver, kidney and hematopoietic diseases; (4) patients with pregnancy or lactation; (5) patients with hisory of serirous mental illness.

Design outcomes

Primary

MeasureTime frame
2-year disease-free survival rate;Disease-free survival, DFS;

Secondary

MeasureTime frame
Quality of life;CD series;

Contacts

Public ContactXingjun Qin

Department of Oral and maxillofacial -head and neck oncology, Shanghai Ninth People's Hospital

qinxj1989@sina.com+86 13621606535

Outcome results

None listed

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