Nimotuzumab in Combined With Chemotherapy for Treatment of IVB Stage,Rrecurrent or Persistent Cer… (NCT06781073) | Clinical Trial Compass
CompletedPhase 3
Nimotuzumab in Combined With Chemotherapy for Treatment of IVB Stage,Rrecurrent or Persistent Cervical Carcinoma
China118 participantsStarted 2017-07-06
Plain-language summary
This is an multicenter, randomized，double-blind, controlled clinical study. The purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with TP regimen (Paclitaxel + Cisplatin) for treatment of IVB stage, recurrent or persistent cervical squamous cell carcinoma .
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. Voluntary and sign a consent form;
✓. Age 18-75 years old ;
✓. Histological diagnosis as cervical squamous cell carcinoma ;
✓. Histologically and/or cytologically confirmed stage IVB or first recurrent or persistent cervical cancer (Mainly refers to the primary radiotherapy or concurrent chemoradiotherapy at least 3 months after the tumor remains or progress) and patients cannot receive surgery or radiation ;
✓. Received taxoplatin + platinum combined chemotherapy stopped taking the drug for at least half a year, or received radiotherapy or concurrent chemoradiotherapy (cisplatin or cisplatin combined with 5-FU) for at least 3 months ;
✓. According to the RECIST 1.1 criteria,there is at least one measurable lesion . The maximum diameter must meet the requirements : CT scan ≥10mm (CT scan thickness is less than 5mm); Clinical routine examination instrument 10mm (tumor lesions that cannot be accurately measured by diameter instruments should be recorded as unmeasurable), chest X-ray ≥20mm; Malignant lymph nodes: pathologically enlarged and measurable, single lymph node CT scan diameter ≥15mm (CT scan Layer thickness not more than 5mm) ;
✓. Patients need to recover from toxic side effects (except decreased hemoglobin) of previous treatments (surgery, chemoradiotherapy, radiation therapy) to grade 1 or below （CTCAE 4.03）;
. Bone metastases alone or multiple metastases with bone metastases requiring radiotherapy for pain relief ;
✕. Patients with recurrence and metastasis after the end of the last administration of neoadjuvant chemotherapy or postoperative adjuvant chemotherapy \< 6 months ;
✕. Received anti-EGFR monoclonal antibody or small molecule TKI within 6 months prior to enrollment ;
✕. Major surgery within 4 weeks or planned surgery or radiation therap ;
✕. Participants in other interventional clinical trials within 1 month prior to informed consent ;
✕. Neurological or psychiatric abnormalities that affect cognitive ability, including brain metastases ;
✕. With clear peripheral neuropathy and related symptoms in the past;