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

NCT06410651 | Recruiting Phase 2

• 1 other identifier: NCC4536
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Cancer; Nimotuzumab; Chemoradiotherapy; Chemotherapy; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  Minimal distance tumor/circumferential resection margin (CRM) \> 1 mm.

  4 months after initiation of induction chemoimmunotherapy

Secondary Outcomes (5)

• Pathological complete response

  4 months after initiation of induction chemoimmunotherapy

• Event-free survival

  1 year after all treatment

• Side effects during chemoradiotherpay

  1 month after chemoradiotherapy

• Postoperative complications

  1 month after surgery

• Overall survival

  1 year after all treatment

Study Arms (1)

Nimotuzumab concurrent with chemordiotherapy followed by surgery

EXPERIMENTAL

Combination Product: Nimotuzumab with chemoradiotherapy

Interventions

Nimotuzumab with chemoradiotherapy COMBINATION_PRODUCT

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

Nimotuzumab concurrent with chemordiotherapy followed by surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

nimotuzumab; 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)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Central Study Contacts

Xin Wang, doctor

CONTACT

13311583220; beryl_wx2000@163.com

Guojie Feng, B.M

CONTACT

16601212285; fenggj18243017306@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 13, 2024
• Study Start: March 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

CN (1)