Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer

Phase 2

Completed

• Conditions: Esophageal
• Interventions: Drug: Nimotuzumab; Radiation: Radiotherapy

• Registration Number: NCT02591784
• Lead Sponsor: Biotech Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2015-08
• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-30
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nimotuzumab group	Nimotuzumab	Nimotuzumab+radiotherapy
Nimotuzumab group	Radiotherapy	Nimotuzumab+radiotherapy

Primary Outcome Measures

Name	Time	Method
The rate of AE(adverse event) or toxicity ( Both acute and chronic toxicity will be evaluated.)	3 months	assement of advers event after using medication based TAAE evaluation form

Secondary Outcome Measures

Name	Time	Method
Complete response	3 months
Partial response (PR)	3 months
Stable disease (SD)	3 months
Progressive disease (PD)	3 months
Median survival time (MST)	2 years
Overall survival (OS)	1 year,2 years

Trial Locations

Locations (5)

Wuhan Union Hospital; 🇨🇳 Wuhan, Hubei, China

The Affiliated tumour hosiptal of HARBIN Medical University; 🇨🇳 Harbin, Heilongjiang, China

Qilu Hospital,Shandong University; 🇨🇳 Jinan, Shandong, China

Cancer Institute & Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, China