Nimotuzumab Concurrent With Chemoradiotherapy for Esophageal Cancer Patients

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · May 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for elderly or malnourished patients with locally advanced esophageal squamous cell carcinoma (ESCC), a type of throat cancer. The researchers want to see if combining a medication called Nimotuzumab, which helps the body fight cancer, with chemotherapy and radiation therapy can improve treatment outcomes. Specifically, they are looking at how many patients can undergo successful surgery after treatment, how well the cancer responds to the therapy, and any side effects that may occur.

To participate in the trial, patients must have a confirmed diagnosis of ESCC and not have received any previous treatment for their cancer. They should also have decent overall health, as indicated by specific health scores and routine blood tests. Participants can expect to receive weekly doses of Nimotuzumab along with other medications and radiation therapy as part of their treatment. The trial is currently recruiting participants, and it aims to provide valuable information that could help improve care for patients with this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed esophageal squamous cell carcinoma.
• • No previous treatment for the esophageal carcinoma.
• • KPS score ≥70.
• • NRS-2002 score≥2.
• • 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:
• • Previous treatment of the esophageal cancer with surgery, radiation, or chemotherapy.
• • 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.