A real world study for nimotuzumab combined with radiotherapy and chemotherapy in the treatment of patients with advanced and recurrent oral and oropharyngeal squamous cell carcinoma

A real world study: nimotuzumab combined with radiotherapy and chemotherapy in the treatment of patients with advanced and recurrent oral and oropharyngeal squamous cell carcinoma

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900021853

Enrollment

Unknown

Registered

2019-03-13

Start date

2018-01-01

Completion date

Unknown

Last updated

2019-03-18

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

Conditions

advanced or recurrent oral and oropharyngeal squamous cell carcinoma

Interventions

1:nimotuzumab+chemotherapy+radiotherapy

2:nimotuzumab+radiotherapy

3:chemotherapy+radiotherapy

4:radiotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 320 patients with advanced or recurrent oral and orophryngeal squamous cell carcinoma, devided into 4 groups, 80 patients each. 1) the patient is willing to join this study voluntarily and sign the informed consent at the beginning; 2) aged at least 18 years old male and female; 3) the diagnosis of advanced or recurrent oral and orophryngeal squamous cell carcinoma was confirmed in pathology; 4) according to RECIST 1.1 criterion, the diameter of lesion is = 10mm on CT scan; the lesion measures = 10mm under clinical instrument examination (the tumor lesion which couldnt be precisely measured by instrument should be recorded as unmeasured), = 20mm on chest radiography; lymph nodes metastasis: enlarged phathologically and measurable, the short diameter of one single lymph node is =15mm; 5) EOCG 0 or 1; 6) evaluating the hematopoietic function of bone marrow: hemoglobin 9.0g/dL; WBC=4.0×10^9/L; neutrophils=2.0×10^9/L; PLT=100.0×10^9/L; 7) evaluating the function of live and kidney: total bilirubin =1.5×ULN; creatinine =1.0 × ULN; AST/ ALT=2.5* ULN; ALP60mL/minthe patients with liver metastasis; AST /ALT=5.0 ULN 8) patients who can take effective contraceptive measures during childbearing age. The compliance of patients is good and follow-up can be carried out according to the requirements of the program.

Exclusion criteria

Exclusion criteria: 1) patient who was allergic to the medicine or part of the medicine prescribed in this study; 2) patient with severe cardiovascular disease such as uncontrollable heart failure, coronary heart disease, rrhythmia, hypertension and history of myocardial infarction in the last 5 years; 3) patient with severe complications such as active gastrointestinal hemorrhage, perforation, jaundice, gastrointestinal obstruction and severe active clinical infection (> grade 2 infection index); 4) female patients during pregnancy and lactation; 5) And patients who have joined other clinical trials in the last 30 days.

Design outcomes

Primary

Measure	Time frame
Overal Survival;	—

Secondary

Measure	Time frame
Progression Free Survival;Quality of life (swallowing, dry mouth,decayed tooth , mandibular necrosis);	—

Countries

China

Contacts

Public ContactWenyong Tu

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

TUWY1233@sh9hospital.org+86 13918907981

Outcome results

None listed

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