Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age

NCT06048913 | Completed Phase 2

• 1 other identifier: GXL-002
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The research subjects of this project are mainly aimed at patients with locally advanced esophageal cancer who cannot be treated surgically, in nimotuzumab 3 months after the end of concurrent chemoradiotherapy, RECIST is pressed as based on physical examination and esophageal barium dialysis or esophageal contrast-enhanced CT Criteria assessed short-term and long-term efficacy separately. By detecting the expression of EGFR in patients with locally advanced esophageal cancer, the relationship between the efficacy of EGFR monoclonal antibody therapy and the long-term prognosis of patients was evaluated. Evaluation of safety, toxicity and side effects during treatment and in the near and long term.

Conditions

Esophageal Carcinoma

Keywords

Nimotuzumab; Concurrent chemoradiotherapy; Locally advanced esophageal cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Progression-free survival was measured from the treatment initiation to either tumor progression (in any form) or death from any cause

  up to 3 years

Secondary Outcomes (5)

• complete response，CR

  through study completion, an average of 18 month

• partial response，PR

  through study completion, an average of 18 month

• no response，NR

  through study completion, an average of 18 month

• Overall survival

  3-year

• Toxic side reactions

  through study completion, an average of 18 month

Study Arms (1)

Nimotuzumab combined with concurrent chemoradiotherapy

EXPERIMENTAL

Treatment options Nimotuzumab （400mg plus normal saline 250ml intravenous infusion for not less than 60 minutes. Starting from week 1 of radiotherapy, 1 dose of the same dose each time for a total of 6 doses）combined with chemoradiotherapy (Oral chemotherapy with the tigio regimen is given on days 1 to 2 of radiotherapy, with the drug dose calculated based on body surface area, and the oral S-1 course from Monday to Friday is synchronized with radiation therapy) for the treatment of locally advanced elderly esophageal cancer patients, in which the S-1 regimen with good clinical tolerability was selected for chemotherapy to evaluate the short-term efficacy and toxic side effects

Drug: Nimotuzumab; Drug: S-1; Radiation: Concurrent radiation therapy

Interventions

Nimotuzumab DRUG

Nimotuzumab 400mg plus normal saline 250ml intravenous infusion for not less than 60 minutes. Starting from week 1 of radiotherapy, 1 dose of the same dose each time for a total of 6 doses. The use of nimotuzumab is not interrupted due to interruption of radiotherapy during the administration until the end of radiotherapy.

Also known as: taixinsheng

Nimotuzumab combined with concurrent chemoradiotherapy

S-1 DRUG

Oral chemotherapy with the S-1 regimen is given on days 1 to 2 of radiotherapy, with the drug dose calculated based on body surface area, and the oral S-1 course from Monday to Friday is synchronized with radiation therapy.

Also known as: chemotherapy

Nimotuzumab combined with concurrent chemoradiotherapy

Concurrent radiation therapy RADIATION

Outline the target area layer by layer on the enhanced CT image, PGTV, PTV. The endangered organs are delineated layer by layer on the cross-section, and extended 0.3cm to form a corresponding plan to endanger the organs. The reverse intensity modulated radiotherapy plan was designed on the Monaco treatment plan system, with a prescribing dose of 56Gy/30F for PTV and 60Gy/30F for pGTV, and the target dose distribution and organ exposure dose were evaluated layer by layer on a cross-sectional surface, and combined with dose-to-volume histogram (DVH) evaluation and optimal treatment plan, the maximum dose of radiation in the spinal cord \< 40 Gy and lung V20\<30%. After the treatment plan is confirmed, the dose is verified on the treatment machine, and the treatment plan is executed after it is accurate. govern

Also known as: Chemoradiotherapy

Nimotuzumab combined with concurrent chemoradiotherapy

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients with stage II-IVB according to AJCC (8th edition, 2018) (IVB included metastasis to the celiac trunk or supraclavicular lymph nodes only) who are not suitable for or refuse surgery can tolerate concurrent chemoradiotherapy and targeted therapy;
• The pathological type is esophageal squamous cell carcinoma;
• Eastern Cooperative Oncology Group performance status of 0-1, age ≥ 75 years old;
• No serious comorbidities, such as severe obstructive emphysema, hypertension, coronary heart disease, diabetes and psychiatric history, etc., and no other malignant tumors;
• All patients had not received EGFR-targeted therapy, immunotherapy, and chemoradiotherapy;
• Expected survival time ≥ 12 weeks.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from this trial:
• Received EGFR monoclonal antibody or EGFR-TKI within six months;
• Participated in other interventional clinical trials within 30 days before screening;
• Patients with serious concurrent diseases, such as heart failure, high-risk uncontrollable arrhythmias, severe myocardial infarction, refractory hypertension, renal failure (CKD-4 and above), thyroid dysfunction, mental illness, diabetes, severe chronic diarrhea (more than 7 bowel movements per day), or patients who are considered unsuitable to participate in this clinical study by the researchers;
• Patients with brain metastases with symptoms or symptom control time of less than 3 months;
• Having a history of other malignant tumors (except for cured cervical carcinoma in situ or basal cell carcinoma of the skin and other malignant tumors that have been cured for more than 5 years);
• The presence of active infection or active infectious disease;
• Patients with multi-segment esophageal malignant tumors or signs of esophageal fistula or perforation;
• Patients whose tumors have invaded important blood vessels as shown by imaging or who are judged by the researchers to be very likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study;
• Those who are allergic to the drugs or their ingredients used in this program;
• Peripheral neuropathy or hearing loss of grade 2 or higher according to the criteria of Common Terminology for Adverse Events (NCI CTCAE V5.0);
• Pregnant or breastfeeding women;
• Patients with a history of psychotropic drug abuse and unable to quit or patients with mental disorders;
• Those who are considered unsuitable to participate in this study by the researcher;
• Those who are unwilling to participate in this study or unable to sign the informed consent.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

nimotuzumab; S 1 (combination); Drug Therapy; Chemoradiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Combined Modality Therapy; Radiotherapy

Study Officials

• Xiaolin GE, PhD

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: September 21, 2023
• Study Start: December 1, 2020
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)