Clinical trial · Interventional
Combination of Nimotuzumab Cisplatin-Vinorelbine in First Line Chemotherapy in Recurring-Persistent Cervical Carcinoma
Phase III Clinical Trial: "Evaluation of the Combination of Nimotuzumab and Cisplatin-Vinorelbine in First Line Chemotherapy in the Survival of Patients With Recurring-Persistent Cervical Carcinoma"
- 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)
This study evauates the global survival of patients following administration of mAb Nimotuzumab hR3 + chemotherapy in the treatment of cervical cancer in first line therapy, after relapsing from chemo-radiotherapy. It is a Phase III, multi-centric, randomized, double blind study; 168 patients will be assigned to Nimotuzumab + Cisplatin/Vinorelbine or placebo + Cisplatin/Vinorelbine. After progression, a second line chemotherapy based on carboplatino/taxol will be administered in both groups. Concomitant administration of Nimotuzumab will be continued every 14 days until limiting toxicity or ECOCG \>3. Tumor markers such as Kras, p53, KI67, and EGFR will be identified. Cardiac toxicity will be evaluated using MRI.
Conditions
Conditions (3)
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 Recurrent or Persistent | — | UNRESOLVED | — |
| Monoclonal Antibody in Cervical Cancer Treatment | — | UNRESOLVED | — |
| Palliative Treatment | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mAb Nimotuzumab | Drug | — | UNRESOLVED |
| Placebo | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- mAb Nimotuzumab + chemotherapy
- interventionNames
- Drug: mAb Nimotuzumab
- type
- PLACEBO_COMPARATOR
- label
- placebo + chemotherapy
- interventionNames
- Device: Placebo
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 11 months
- description
- Patient's survival since inclusion until death.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who grant their written consent to participate in the trial; * With persistent or recurrent local and/or systemic cervical cancer with a measurable disease through physical examination, CAT, or MRI; * Diagnosed 90 days after concluding administration of chemotherapy + radotherapy to pelvis or pelvic extended fields chemo-radiotherapy; * Pathological report with epidermal carcinoma, adenocarcinoma, adenosquamous carcinoma and glassy cell carcinoma; * ECOG Performance Status ≤2; * Life expectancy \>6 months; * LVEF \>50 (MUGA or ecocardiogram) * Normal function of organs and of bone marrow defined by laboratory parameters. Exclusion Criteria: * Pregnant or breastfeeding patients; * Small cells and/or neuroendocrine cervical cancer; * Receiving other oncospecific drug under research; * Allergy history to compounds of chemical or biological similar composition to the monoclonal antibody being evaluated or to chemotherapeutic agents; * Intercurrent non controlled diseases including active infections, symptomatic congestive cardiac failure, unstable angina pectoris, cardiac arrhythmia, decompensated diabetes and psychiatric disorders. * With a second tumor; except for those who have received appropriate treatment for skin carcinomas (basal or squamous). * Previous or concomitant malignancy except for non-melanoma skin carcinoma. * Social, family or geographic conditions that suggest a poor study compliance.
References
Publications (0)
Data not yet available