Fruquintinib in Combination With Tislelizumab Followed by Radiotherapy in Esophageal Squamous Cell Carcinoma

Launched by HEBEI MEDICAL UNIVERSITY FOURTH HOSPITAL · Oct 15, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with advanced esophageal squamous cell carcinoma, a type of cancer that affects the esophagus. The study is looking at a combination of two medications: fruquintinib, which helps prevent the growth of blood vessels that feed tumors, and tislelizumab, an immune therapy that helps the body's immune system fight cancer. Participants in the trial will have previously received immune checkpoint inhibitors and will be treated with this combination therapy followed by radiotherapy.

To be eligible, participants must be at least 18 years old, have a confirmed diagnosis of esophageal cancer, and have previously undergone chemotherapy that included specific drugs like cisplatin or carboplatin. They should also be in relatively good health and have a life expectancy of at least six months. During the trial, participants can expect close monitoring by the research team and will undergo various tests to check their health and the effectiveness of the treatment. This trial is currently recruiting participants, and it’s important to know that those with certain health conditions or who have recently received other cancer treatments may not qualify.

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Eligibility criteria

• Inclusion Criteria:
• • Voluntary participation and written signed informed consent;
• • Age ≥ 18 years old, gender is not limited;
• • Histologically or cytologically confirmed limited-stage small cell lung cancer (2009 AJCC/UICC/IASLC lung cancer TNM staging criteria, limited-stage SCLC is any T stage, any N stage, and M0), and patients with suspected brain or bone metastasis at the time of screening should undergo brain MRI or ECT before study enrollment;
• • There are immunohistochemical results;
• • Chemotherapy must include either cisplatin or carboplatin, in combination with etoposide;
• • Physical status score ECOG 0-1;
• • Weight \> 40 kg;
• • Expected survival ≥ 6 months;
• • According to RECIST 1.1 guidelines, at least one lesion (not previously receiving radiotherapy) with a maximum diameter ≥ 10 mm as accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) at baseline (except lymph nodes, whose short axis must be ≥ 15 mm); And the lesion is suitable for repeated accurate measurement.;
• • No previous immunotherapy;
• • no serious abnormalities of haematopoietic, cardiac, pulmonary, hepatic; and renal functions and immunodeficiency (Haematology: white blood cells ≥3.5×109/L; neutrophils ≥1.5×109/L; haemoglobin ≥90g/L; platelets
• • ≥100×109/L. Liver and kidney function: total bilirubin ≤1.5 times the upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) ≤2.5 times the upper limit of normal; creatinine ≤1.5 times the upper limit of normal; albumin ≥30 g/L. Coagulation: International Normalised Ratio (INR) or Prothrombin Time (PT) or Activated Partial Thromboplastin Time (APTT)
• • ≤ 1.5 times ULN; if the subject is receiving anticoagulation therapy, PT or INR is acceptable as long as the PT or INR is within the range of the anticoagulant drug formulation. Echocardiographic assessment: left ventricular ejection fraction (LVEF) ≥ low limit of normal (50%). Pulmonary function FEV1 ≥70% of % of predicted value and DLCO ≥60% of % of predicted value).
• • The female patient has evidence of postmenopausal status, or the urine or serum pregnancy test results of the premenopausal woman are negative. Women who stop menstruating for 12 months without other medical reasons are considered menopausal.
• Exclusion Criteria:
• • Distant organ metastases (excluding supraclavicular lymph nodes) as determined by CT evaluation during screening and prior imaging;
• • have received prior radiotherapy to the chest;
• • have medical contraindications to etoposide - platinum (carboplatin or cisplatin) based chemotherapy;
• • having any active autoimmune disease or a history of autoimmune disease (e.g. interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included if hormone replacement therapy is effective), etc.), and a history of immunosuppressive drug use within 28 days, with the exception of the use of hormones for the purpose of dealing with toxicity from radiotherapy;
• • Previously received or are receiving other PD-1 antibody therapy or other immunotherapy targeting PD-1/PD-L1, or are currently participating in other interventional clinical studies for treatment;
• • Have received other anti-tumour therapy (including herbal therapy with anti-tumour effect) within 4 weeks prior to the first dose of the study; have received long-term systemic immunotherapy or hormone therapy (except physiological replacement therapy, e.g., oral thyroxine for hypothyroidism) within 4 weeks prior to the first dose of the study; and have been treated with other experimental drugs or interventional clinical studies within 4 weeks prior to the first dose of the study;
• • Patients with uncontrolled clinical cardiac symptoms or disease such as
• • (1) NYHA class II or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, and (4) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
• • with congenital or acquired immune function defects (e.g., HIV-infected patients), active hepatitis B (HBV-DNA ≥104 copies/ml) or hepatitis C (hepatitis C antibody-positive with HCV-RNA above the lower limit of detection of the analytical method), or active tuberculosis;
• • Have an active infection or unexplained fever \>38.5°C within 2 weeks prior to screening (at the investigator's discretion, subjects may be enrolled for fever arising from tumours);
• • In the judgement of the investigator, the subject has other factors that may cause him/her to be forced to terminate the study in the middle of the study, e.g., suffering from other serious illnesses (including psychiatric illnesses) that require comorbid treatment, family or social factors that may affect the safety of the subject or the collection of trial data.