Clinical trial · Interventional
Study of Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer
Efficacy and Safety of Nimotuzumab Combined With Radiotherapy and Concurrently Cisplatin in Patients With Stage IIB-IVA Cervical Squamous Cell Carcinoma
NCT03469531CI-TRIAL-00034308unknownPhase 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 combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical squamous cell carcinoma.
Conditions
Conditions (8)
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 Adenosquamous Cell Carcinoma | Cervical Adenosquamous Carcinoma | ALIAS | 0.90 |
| Cervical Squamous Cell Carcinoma in Situ | Cervical Squamous Intraepithelial Neoplasia 3 | ALIAS | 0.90 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Stage IB Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IVA Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brachytherapy | Radiation | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
| external-beam radiation | Radiation | — | UNRESOLVED |
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- experimental group
- description
- Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy as the patients in experimental group.
- interventionNames
- Drug: Nimotuzumab
- Drug: Cisplatin
- Radiation: external-beam radiation
- Radiation: brachytherapy
- type
- ACTIVE_COMPARATOR
- label
- control group
- description
- Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group.
- interventionNames
- Drug: Cisplatin
- Radiation: external-beam radiation
- Radiation: brachytherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * All volunteers will sign the informed consent. * Histologically confirmed squamous cell of the uterine cervix, EGFR(+). * The FIGO stage (IIB-IVA) and was not available for surgical treatment. * There is at least one tumor lesion that is measurable by RECIST. * During the study, contraception should be ensured. * Karnofsky performance status \>60. * WBC \>= 3,000/mm\^3 * Absolute granulocyte count \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * INR \< 1.5 * Total bilirubin =\< 1.5 mg/dL * Serum creatinine =\< 1.5 mg/dL * AST and ALT =\< 2.5 times upper limit of normal (ULN) * Serum calcium =\< 1.3 times ULN * Hemoglobin \>= 9g/dL (transfusion allowed) Exclusion Criteria: * Positive para-aortic lymph nodes or positive lymph nodes beyond pelvic * Prior invasive malignancy (except nonmelanomatous skin cancer) * Contraindication of chemotherapy; * Rare pathological subtype; * Cervical cancer patients underwent hysterectomy, laparoscopic surgery or systemic chemotherapy.
References
Publications (0)
Data not yet available
No reference posted for this study.