Induction Chemoimmunotherapy Combined With Chemoradiotherapy in Esophageal Cancer

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced esophageal cancer, specifically a type called esophageal squamous cell carcinoma (ESCC). The researchers are looking at how effective and safe a combination of a new immunotherapy drug called cardonilizumab along with chemoradiotherapy (a mix of chemotherapy and radiation) can be in treating this cancer. The goal is to improve the chances of survival and overall outcomes for patients who currently have limited options.

To participate in this trial, patients need to be between 18 and 80 years old and have a confirmed diagnosis of locally advanced ESCC. They should be in good overall health, with normal blood counts and organ function. However, individuals with other serious health conditions, previous cancer treatments, or specific complications related to their cancer may not qualify. Participants can expect close monitoring and support throughout the study as they receive this combined treatment. It's important for potential participants to discuss this option with their healthcare provider to see if it might be a good fit for their situation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18-80 years old；
• • Eligible patients were histologically confirmed esophageal squamous cell carcinoma;
• • Eligible patients were proven locally advanced ESCC (cT1-2N1-3M0-1, cT3/T4N0-3M0-1, M1 was limited to supraclavicular lymph node metastasis）diagnosed by computed tomography \[CT\] and/or endoscopic ultrasonography \[EUS\] according to the American Joint Committee on Cancer (AJCC) 8th edition staging system；
• • ECOG PS score: 0\~1；
• • 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);
• • patients who had previously received other treatments
• • 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
• • Those who already have esophageal perforation or are at high risk of esophageal perforation
• • Patients whose tumors invade close to large blood vessels and are at risk of bleeding in the
• • there are active infections, such as active tuberculosis and hepatitis
• • There are contraindications to immunotherapy.
• • Pregnant or lactating women and women of childbearing age do not take reliable contraceptive measures
• • Combined with serious cardiovascular diseases, such as uncontrolled heart failure, coronary heart disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or a history of myocardial infarction within the past 6 months; and those combined with other uncontrolled acute and chronic diseases such as hypertension and diabetes.
• • Violation of inclusion and exclusion criteria, or other reasons that the researcher believes cannot continue the study of drug treatment.