Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age
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ClinicalTrials.gov Identifier: NCT06048913 |
Recruitment Status :
Enrolling by invitation
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
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Condition or disease | Intervention/treatment | Phase |
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Esophageal Carcinoma | Drug: Nimotuzumab Drug: Tigio Radiation: Concurrent radiation therapy | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 45 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age |
Actual Study Start Date : | July 1, 2022 |
Estimated Primary Completion Date : | July 1, 2025 |
Estimated Study Completion Date : | July 1, 2028 |
Arm | Intervention/treatment |
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Experimental: Nimotuzumab combined with concurrent chemoradiotherapy
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 tigio course from Monday to Friday is synchronized with radiation therapy) for the treatment of locally advanced elderly esophageal cancer patients, in which the tigio regimen with good clinical tolerability was selected for chemotherapy to evaluate the short-term efficacy and toxic side effects
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Drug: Nimotuzumab
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 Taixinsen is not interrupted due to interruption of radiotherapy during the administration until the end of radiotherapy.
Other Name: taixinsheng Drug: Tigio 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 tigio course from Monday to Friday is synchronized with radiation therapy.
Other Name: chemotherapy Radiation: Concurrent radiation therapy 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
Other Name: Chemoradiotherapy |
- Overall Survival [ Time Frame: up to 3 years ]Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.
- complete response,CR [ Time Frame: through study completion, an average of 18 month ]After treatment, the lesion completely disappears, or all symptoms and signs of the unmeasurable lesion completely disappear, and the lesion completely disappears in X-ray and bone imaging examinations for bone metastasis, lasting for at least 4 weeks
- partial response,PR [ Time Frame: through study completion, an average of 18 month ]The sum of the maximum diameters of the target lesion decreases by more than 30% and lasts for more than 4 weeks.
- no response,NR [ Time Frame: through study completion, an average of 18 month ]At the end of radiotherapy, there is residual tumor or no significant improvement in the lesion, but there are still significant filling defects and worsening of niche or stenosis
- Toxic side reactions [ Time Frame: through study completion, an average of 18 month ]The US Toxicity Evaluation Standard (CTC3. O) is divided into O~4 grades, and the evaluation of acute radiation reactions adopts RTOG/EROTC criteria
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Ages Eligible for Study: | 70 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Locally advanced senile esophageal cancer that cannot be treated surgicallyr (T3-4N0 or any N+);
- The pathological type is esophageal squamous cell carcinoma;
- immunohistochemistry showed medium and strong expression of EGFR;
- No signs of perforation, such as protruding spikes, niche shadow formation, twisted angles and mediastinal disorder;
- Karl Fischer score (KPS) ≥ 70, age ≥ 70 years old, can eat a semi-liquid diet;
- 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.
Exclusion Criteria:
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06048913
China, Jiangsu | |
The First Affiliated Hospital of Nanjing Medical University | |
Nanjing, Jiangsu, China, 210009 |
Study Director: | Xiaolin GE, PhD | The First Affiliated Hospital with Nanjing Medical University |
Responsible Party: | The First Affiliated Hospital with Nanjing Medical University |
ClinicalTrials.gov Identifier: | NCT06048913 |
Other Study ID Numbers: |
GXL-002 |
First Posted: | September 21, 2023 Key Record Dates |
Last Update Posted: | September 21, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Nimotuzumab Concurrent chemoradiotherapy Locally advanced esophageal cancer |
Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms |
Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Nimotuzumab Antineoplastic Agents, Immunological Antineoplastic Agents |