A Prospective, Randomized Controlled, Open Label, Multicenter, Phase II Clinical Study Evaluating the Efficacy and Safety of Nimotuzumab Combined With Concurrent Chemoradiotherapy in Elderly Patients With Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

investigators plan to conduct a multicenter, prospective, randomized controlled, open, phase clinical study to compare the efficacy and safety of nimotuzumab with concurrent chemoradiation alone in elderly participants with advanced esophageal squamous cell carcinoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 75
Healthy Volunteers: f
View:

• The subject volunteered to join the study, signed the informed consent form, had good compliance, and cooperated with the follow-up;

• Age 70 or above, male or female;

• The ECOG score is 0-1 point;

• Oesophageal squamous cell carcinoma diagnosed by histology or cytology;

• According to the efficacy evaluation criteria of solid tumors (RECIST 1.1), at least one measurable lesion, and the measurable lesion should not receive local treatment such as radiotherapy (the lesion located in the previous radiotherapy area can also be selected if the progression is confirmed and meets the RECIST1.1 criteria);

• Stage II-IVB (IVB stage only includes supraclavicular/abdominal lymph node metastasis, does not include any other distant metastasis), can tolerate synchronous radiotherapy, chemotherapy, and targeted therapy

• Expected survival time of 6 months;

• Main organ function is normal, that is, meet the following criteria:

⁃ 1\) Blood routine examination:

• HBG≥90g/L;

• ANC≥1.5×109/L;

• PLT ≥80×109/L; 2) Biochemical examination:

⁃ a.ALB≥30g/L; B. ALT and AST≤2.5ULN; ALT and AST 5 ULN; c.TBIL≤1.5ULN; D. Plasma Cr≤1.5ULN or creatinine clearance (CCr) of 60 ml/min; 9. Echocardiographic assessment: left ventricular ejection fraction (LVEF) low normal value (50%); 10. Women of childbearing age should agree to use contraception (e. g. intrauterine devices, contraceptives or condoms) during the study and within 6 months after the study; serum or urine pregnancy tests were negative within 7 days before study enrollment and must be non-lactating patients; men who agree to use contraception during the study and within 6 months after the end of the study period.

Locations
Other Locations
China
The First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Xiaolin MM GE, PHD
doctorsxl@163.com
13951818797
Time Frame
Start Date: 2024-03-31
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 95
Treatments
Experimental: Nimotuzumab plus concurrent chemoradiotherapy group
S-1: TBSA\<1.4 m²,40mg;TBSA=1.4-1.6 m²,50mg;TBSA\>1.6 m²,60mg,po,BID, During the synchronous period of radiotherapy,QW,D1-D5, After radiotherapy,Q3W,D1-14,lasting for 1 year Nimotuzumab 400mg, iv, D1, Week 1; Nimotuzumab 200mg, iv, D8, QW, weeks 2-5. The prescribed dose required 95%PTV 50.4Gy/1.8Gy/28f SIB-PGTV 59.92Gy/2.14Gy/28 次
Active_comparator: concurrent chemoradiotherapy group alone
S-1: TBSA\<1.4 m²,40mg;TBSA=1.4-1.6 m²,50mg;TBSA\>1.6 m²,60mg,po,BID, During the synchronous period of radiotherapy,QW,D1-D5, After radiotherapy,Q3W,D1-14,lasting for 1 year The prescribed dose required 95%PTV 50.4Gy/1.8Gy/28f SIB-PGTV 59.92Gy/2.14Gy/28 次
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov

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