Trial Title:
Fruquintinib in Combination With Tislelizumab Followed by Radiotherapy in Esophageal Squamous Cell Carcinoma
NCT ID:
NCT06646588
Condition:
Esophageal Neoplasms
Conditions: Official terms:
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Esophageal Neoplasms
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fruquintinib
Description:
Fruquintinib: Oral, once daily, 2 weeks on and 1 week off. The product can be taken with
food or orally on an empty stomach, and needs to be swallowed whole. It is recommended
that the dose be taken at the same time each day; if the patient vomits after taking the
dose, no refill is needed; a missed dose should not be added the next day, but the next
prescribed dose should be taken as usual.
Arm group label:
Fruquintinib in Combination With Tislelizumab followed by radiotherapy
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Tislelizumab: intravenous drip 200mg，day1，once every three weeks.
Arm group label:
Fruquintinib in Combination With Tislelizumab followed by radiotherapy
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
Radiotherapy synchronised with drugs.
Arm group label:
Fruquintinib in Combination With Tislelizumab followed by radiotherapy
Summary:
According to the Global Burden of Disease Study, the number of esophageal cancer cases
globally increased from 319,969 in 1990 to 534,563 in 2019, a relative increase of 67.07
per cent. In addition, GLOBOCAN 2020 reported that the global incidence of esophageal
cancer climbed to 604,100, accounting for 3.1% of all tumor sites and ranking 7th out of
36 cancers. In addition, the number of global deaths from esophageal cancer increased
from 319,332 in 1990 to 498,067 in 2019, a relative increase of 55.97%.GLOBOCAN 2020
reported about 544,076 new esophageal cancer deaths, which accounted for 5.5% of all
study centres and ranked 6th among 36 cancers. Chemotherapy is the standard of care for
advanced esophageal squamous cell carcinoma, but conventional chemotherapy has limited
efficacy, and studies have shown lower median overall survival with chemotherapy in
patients with advanced esophageal cancer compared to patients with other stages. In
recent years, with the first-line approval of immune checkpoint inhibitors, the treatment
of esophageal cancer has entered the immune era. Immune checkpoint inhibitors have become
an important therapeutic option for patients with advanced esophageal cancer who have
failed chemotherapy. This study will explore the efficacy and safety of this small
molecule anti-angiogenic drug, fruquintinib, in combination with tislelizumab in
esophageal squamous cell carcinoma previously treated with immune checkpoint inhibitors.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fourth Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Zip:
050011
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenbin Shen, MD
Phone:
15831183879
Email:
wbshen2024@hebmu.edu.cn
Contact backup:
Last name:
Jinrui Xu, PhD
Email:
349670063@qq.com
Start date:
April 1, 2024
Completion date:
April 30, 2027
Lead sponsor:
Agency:
Hebei Medical University Fourth Hospital
Agency class:
Other
Source:
Hebei Medical University Fourth Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06646588
