Clinical trial · Interventional
Phase II Clinical Trial of Concurrent Chemoradiotherapy Combined Nimotuzumab for Stage IIB-IVA Cervical Cancer
Efficacy and Safety of Radiotherapy Concurrently Combined With Cisplatin and Nimotuzumab for Patients With Locally Advanced Cervical Cancer
NCT02705612CI-TRIAL-00021291unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this phase II trial is to determine the feasibility and efficacy of nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable locally advanced 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| External Beam Radiation Therapy | Radiation | — | UNRESOLVED |
| Internal Radiation Therapy | Radiation | — | UNRESOLVED |
| nimotuzumab | Drug | Nimotuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- control group
- description
- Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy.
- interventionNames
- Drug: Cisplatin
- Radiation: External Beam Radiation Therapy
- Radiation: Internal Radiation Therapy
- type
- EXPERIMENTAL
- label
- experimental group
- description
- Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group. Patients also receive nimotuzumab during the external radiotherapy.
- interventionNames
- Drug: Cisplatin
- Radiation: External Beam Radiation Therapy
- Radiation: Internal Radiation Therapy
- Drug: nimotuzumab
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 18 Years to 70 Years，female * Histological diagnosis of squamous cell carcinoma of cervix, FIGO stage IIB-IVA,with diameter 4-6 cm, without distant metastasis. * no chance of surgery confirmed by more than two deputy chief doctors of gynecology. * Moderate or high expression of EGFR * The function of main organ is normal, including blood, heart, lung, liver, and kidney. Without history of hypertension, stroke. Blood pressure is normal before treatment. * WBC≥3.5×10E9/L，ANC≥1.5×10E9/L；HB≥90g/L，PLT≥100×10E9/L * ALT, AST and Cr below 1.5 times of normal level * Willing to accept treatment * Ability to comply with trial requirements KPS≥70 Exclusion Criteria: * Evidence of distance metastasis * Impossible to measure the diameter of tumor, or the tumor is too huge (diameter\>6cm) * Couldn't examine with pelvic MRI due to a variety of reasons * Used to treat with radiotherapy chemotherapy or molecular target therapy and immune therapy * Diagnosed with another malignant tumor in 5 years * Used to be a volunteer of other clinical trial. * Used to be allergic reaction with grade 3 or 4 degree to any experimental drugs * Severe medical history of lung ,liver, kidney or heart. * Active infection in any part of the whole body. * Examination results showed radiotherapy contraindications
References
Publications (0)
Data not yet available
No reference posted for this study.