Clinical trial · Interventional
Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer
Phase II Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries. The clinical phaseⅡtrial is designed to assess the resection rate and pathological complete response of nimotuzumab plus carboplatin and paclitaxel in patients with cervical cancer.
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 |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Nimotuzumab | Biological | Nimotuzumab | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nimotuzumab plus chemoradiotherapy
- interventionNames
- Biological: Nimotuzumab
- Drug: Carboplatin
- Drug: Paclitaxel
Primary outcomes (2)
- measure
- resection rate
- timeFrame
- the day right after surgery
- measure
- Pathological response rate
- timeFrame
- the day right after surgery
Secondary outcomes (2)
- measure
- objective response rate（ORR）
- timeFrame
- The first seven weeks after the end of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age:18-70 years 2. Histological confirmed Cervical squamous cell carcinoma 3. FIGO Stage: IB2-IIIB 4. Tumor lesions and stages are confirmed by the internal medicine, obstetrics and gynecology inspection, including a pelvic exam and abdominal and pelvic CT,.if necessary, laparoscopy, cystoscopy and pelvic MRI examination will be taken. 5. At least one lesions can be measured 6. No previous therapy 7. ECOG performance status 0-2 8. Life expectancy of more than 6 months 9. Normal hematology:Haemoglobin≥90g/L,white blood cell(WBC)≥4×109/L Absolute neutrophil count≥1.5×109/L,platelet count≥100×109/L, normal renal function: serum creatinine\<1.5mg/dl or creatinine clearance rate\>60ml/min；normal liver function:TBIL≤1.5 ULN, AST and ALT≤1.5 ULN 10. Without lung or heart disease 11. Without active infection 12. Signed informed consent and submit to the organization of research Exclusion Criteria: 1. Severe systemic or uncontrolled disease, unfit for chemotherapy 2. Neuropathy caused by any reason 3. Psychiatric disease 4. Other malignant tumor 5. Bilateral renal pelvis and ureter hydrocephalus who can't be alleviated by ureteral stent or percutaneous nephrostomy, Abnormal serum creatinine level 6. Infection and severe systemic disease 7. Received other anti EGFR monoclonal antibody treatment 8. Participation in other interventional clinical trials 9. Allergic constitution or history of drug allergy 10. Pregnant or breast-feeding or refused to take contraceptive method 11. Poor compliance
References
Publications (0)
Data not yet available