Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Unresectable Esophageal Squamous Cell Carcinoma

Esophageal Cancer Clinical Trial

Official title:

Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma After Failure of Chemotherapy：A Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06410651
• Other study ID #: NCC4536
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Xin Wang, doctor
• Phone: 13311583220
• Email: beryl_wx2000[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) who failed to induction chemo(immuno)therapy had poor prognosis. Radiotherpy was an important and effective treatment in treating ESCC. The present study is a one-arm trial that seeks to evaluate the efficacy in patients with unresectable ESCC. The study objectives include R0 resection rate, complete pathological response and treatment toxicity, etc.

Nimotuzumab is a recombinant humanized monoclonal antibody against EGFR. Its efficacy and safety in patients with esophageal cancer have been confirmed by many studies.

The current prospective phase II study aimed to evaluate the efficacy and safety of a combination regimen comprising chemotherapy with nimotuzumab and S-1 and concurrent radiotherapy for patients who are not sensitive to induction chemo(immuno)therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed esophageal squamous cell carcinoma. Tumor response was evaluated as stable or locoregionally progresive disease or assessed by surgeons being unresectable (without distant metastasis) after induction chemo(immuno)therapy.

• Cycles of induction chemo(immuno)therapy was 2-4.

• KPS score =70.

• Main organs and bone marrow function are normal: routine blood tests: hemoglobin (Hb) =100g/L ; absolute neutrophil count (NEUT)=1.5×109/L; platelets (PLT) =100×109/L; white blood cell (WBC)=3.5×109/L,biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =1.5×UNL; serum total bilirubin (TBIL) =1.5×UNL; serum creatinine ( Cr) 1.0×1.5UNL, and BUN=1.0×UNL;

Exclusion Criteria:

• Those combined with other primary malignant tumors other than esophageal cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);

• At the time of diagnosis, there were distant and hematogenous metastases beyond the supraclavicular lymph node region, including retroperitoneal multiple lymph node metastasis, bone metastasis, brain metastasis, lung metastasis, liver metastasis, malignant pleural effusion and ascites

• There are active infections, such as active tuberculosis and hepatitis

• There are contraindications to targeted therapy.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Chemoradiotherapy
• Chemotherapy
• Esophageal Cancer
• Esophageal Squamous Cell Carcinoma
• Immunotherapy
• Nimotuzumab

Intervention

Combination Product:
• Nimotuzumab with chemoradiotherapy
Radiotherapy, 40-50.4Gy/20-28f. Nimotuzumab 400mg, ivgtt, W2d. Chemotherapy, S-1, 40-60mg/m2, on BSA,orally twice daily on radiotherapy days.

Locations

Country	Name	City	State
China	National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0 resection rate	Minimal distance tumor/circumferential resection margin (CRM) > 1 mm.	4 months after initiation of induction chemoimmunotherapy
Secondary	Pathological complete response	the complete remission of all viable cancer cells in any of the specimens from surgery, including the primary site and lymph nodes	4 months after initiation of induction chemoimmunotherapy
Secondary	Event-free survival	the time from start of induction chemo(immuno)therapy to progression, relapse, all-cause death, or the last day of follow-up	1 year after all treatment
Secondary	Side effects during chemoradiotherpay	the time from start of chemoradiotherapy to 1 month after chemoradiotherapy	1 month after chemoradiotherapy
Secondary	Postoperative complications		1 month after surgery
Secondary	Overall survival	the time from start of induction chemo(immuno)therapy to all-cause death, or the last day of follow-up	1 year after all treatment