Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer

Biotech Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Esophageal

Treatments: Drug: Nimotuzumab; Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02591784

BT-IST-ESO-002

Details and patient eligibility

About

Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The phase II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.

Full description

Clinical efficacy has been shown in adult with head and neck cancer. The phase II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.

Enrollment: 42 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. pathologically or cytology diagnosed phase II-III esophageal carcinoma or IV thoracic segments carcinoma with the supraclavicular lymph nodes metastasis.
2. with the measureable lesion of the newly diagnosed the esophageal carcinoma.
3. age 18-75 years old
4. ECOG≤2
5. Expect survival date ≥3 months
6. without serious diseases of important organs
7. signature in the inform consent.

Exclusion criteria

1. pregnant or breast-feeding women or using a prohibited contraceptive method.
2. with psychiatric diseases.
3. with serious diseases or uncontrolled infection.
4. with history of other tumors.
5. participation other clinical trials within 1 month prior to inclusion in the trial.
6. not the first antitumor treatment .

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Nimotuzumab group

Experimental group

Description:

Nimotuzumab+radiotherapy

Treatment:

Drug: Nimotuzumab

Radiation: Radiotherapy