Clinical trial · Interventional
Nimotuzumab With Radiotherapy in the Treatment of Anal Canal Cancers
A Phase II Clinical Study Using Nimotuzumab in Combination With External Beam Radiation Therapy in the Treatment of Patients With Carcinomas of the Anal Canal
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low recruitment
Summary
Brief summary (as posted)
The objective of this study is to demonstrate the feasibility of using Nimotuzumab and radiation in the treatment of squamous cell carcinomas of the anal canal in order to achieve a 65% local control rate with a better toxicity profile than the conventional treatment. Patients with high toxicity risks (HIV+ and fragile patients) will be selected for this study.
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 |
|---|---|---|---|
| Squamous Cell Carcinoma of Anal Canal | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensity Modulated Radiation Therapy (IMRT) | Radiation | — | UNRESOLVED |
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nimotuzumab
- description
- Patients will receive weekly injections of Nimotuzumab (200mg/injection) for 12 weeks and standard external beam radiotherapy
- interventionNames
- Drug: Nimotuzumab
- Radiation: Intensity Modulated Radiation Therapy (IMRT)
Primary outcomes (2)
- measure
- Toxicity
- timeFrame
- 1 month post end of treatment
- description
- Toxicity evaluation will include all toxicities occurring while the patient is receiving treatment, and will be monitored using the CTCAE guide version 3.0.
- measure
- Local tumor response rate
- timeFrame
- 8 weeks post end of radiation treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: For both step I and II: * Patients with histologically confirmed squamous cell carcinoma of the anal canal * Aged 18 years or older * ECOG: 0-1-2 * Adequate contraception in women of child-bearing potential and for men * Ability to understand and the willingness to sign a written informed consent document. * HIV-positive patients with T1-2 anal canal tumors, or * Patients with anal canal tumors not eligible for conventional chemotherapy (for example, due to age and/or co-morbidities) * Patients who have already started radiotherapy for anal canal cancer For step II: * HIV-positive patients with T1, T2 anal canal tumors * HIV-negative patients not eligible for conventional chemotherapy (for example, due to age and/or co-morbidities) * HIV-negative patients with T1-2 anal canal cancer Exclusion Criteria: For both step I and II: * Patients receiving any other investigational agents * Previous treatment with anti-EGFR drugs * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nimotuzumab or other agents used in study. * Previously treated with pelvic radiotherapy. * Lesions not suitable for radiotherapy * Patients with uncontrolled hypercalcemia * Uncontrolled intercurrent illness * Pregnant or breast-feeding women * Any concurrent active malignancy * Patients with T3-4 anal canal tumors or patients with nodes positive. Step I: * HIV-negative patients with anal canal tumors that are judged suitable for current treatment consisting in radiotherapy and 5-FU and MMC chemotherapy
References
Publications (0)
Data not yet available