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Trial Title:
Tislelizumab Combined With Chemotherapy or Radiotherapy in the Treatment of Advanced or Recurrent Metastatic Elderly Esophageal Cancer
NCT ID:
NCT05628610
Condition:
Esophageal Cancer
Conditions: Official terms:
Esophageal Neoplasms
Paclitaxel
Carboplatin
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
200mg d1, Q3W
Arm group label:
Tislelizumab combined with chemotherapy
Arm group label:
Tislelizumab combined with radiotherapy
Intervention type:
Radiation
Intervention name:
Radiation
Description:
Radiotherapy dose: 5,000 c G y / 30f
Arm group label:
Tislelizumab combined with radiotherapy
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Paclitaxel: 150mg / m2 ,d1, q3w
Arm group label:
Tislelizumab combined with chemotherapy
Intervention type:
Drug
Intervention name:
Platinum: cisplatin, carboplatin, naidaplatin and other platinum drugs
Description:
cisplatin, carboplatin, naidaplatin and other platinum drugs
Arm group label:
Tislelizumab combined with chemotherapy
Summary:
To compare the objective response rate (ORR) and safety of tislelizumab combined with
chemotherapy and Tislelizumab combined with radiotherapy in elderly patients with
esophageal cancer with advanced or recurrent metastasis
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Signed a written informed consent and volunteered to join the study;
- Patients with esophageal squamous cell carcinoma confirmed by pathological
histological and / or immunohistochemical examination or progressing after surgical
resection, (the 8th edition, 2017) with UICC / AJCC TNM stage cT4N0-2M0, c any
TN3M0, or c any T any NM1 (clinical stage IV);
- Unresectable advanced, recurrent, or metastatic oesophageal SCC;
- Age: 70 years old;
- E CO G P S 0-2
- Has not received any systemic antitumor treatment for esophageal cancer, including
radiotherapy, chemotherapy, targeted, immunotherapy, etc.;
- At least one measurable lesion was present
- Main organs have normal function, including:
A) Routine blood tests (no blood components, cell growth factors, whitening agents,
platelets, anemia drugs are allowed within 14 days before the first use of the study
drug) Leukocyte count was at 3.0109/L Neutrophil count was at 1.0109/L Platelet count was
at 8,0109/L Hemoglobin was at 80 g / L b) Blood biochemical examination: Total bilirubin
was at 1.5 ULN ALT ≤ 2.5×ULN ，AST ≤2.5×ULN ， Serum creatinine of 1.5 ULN, or creatinine
clearance of 45 mL/min (Cocheroft-Gault formula, see Annex 2)
-The subjects had good compliance and cooperated with the follow-up
Exclusion Criteria:
- There is uncontrollable pleural effusion, pericardial effusion or ascites that
requires repeated drainage;
- Poor nutritional status, BMI <18.5 Kg / m2; if corrected after symptomatic
nutritional support, further enrollment can be considered after evaluation by the
principal investigator;
- Gastrointestinal bleeding (bleeding volume> 200ml / day);
- Patients adjudged by the researchers to have deep ulcers;
- Previous history of allergy to monoclonal antibodies, any component of tirellizumab,
paclitaxel, cisplatin, or other platinum drugs;
- Has received or are receiving any of the following treatments:
A) Any radiotherapy, chemotherapy, or other antitumor drugs directed against the tumor;
Study drug b) Treatment with immunosuppressive drugs or systemic hormones for
immunosuppression purposes within 2 weeks of the first study drug (dose or equivalent
dose> 10mg / day); inhaled or topical steroids and doses> 10mg / day prednisone or
equivalent dose of adrenal corticoid replacement in the absence of active autoimmune
disease; The c) Acceptance of a live attenuated vaccine within 4 weeks before the first
use of the study drug; d) Major surgery or severe trauma within 4 weeks prior to the
first use of the study drug;
- History of any active autoimmune or autoimmune disease, including but not limited
to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis,
nephritis, hyperthyroidism, hypothyroidism (considered after HRT); patients with
psoriasis or asthma / allergy in childhood remission and adults without any
intervention, but patients requiring bronchodilator are not included;
- A history of immunodeficiency, including positive HIV testing, or other acquired or
congenital immunodeficiency diseases, or a history of organ transplantation or
allogeneic bone marrow transplantation;
- Poor clinical cardiac symptoms or disease, including but not limited to:
Such as (1) heart failure of grade NYHAII or above; (2) unstable angina pectoris; (3)
myocardial infarction within 1 year; (4) clinical significance of supraventricular or
ventricular arrhythmia without clinical intervention or clinical intervention is not well
controlled;
- Severe infection (CTCAE> 2) within 4 weeks before initial use of study drug, such as
severe pneumonia, bacteremia, or infection complications requiring hospitalization;
baseline chest imaging indicates active lung inflammation, symptoms or signs of
infection within 14 days prior to initial use of study drug, or requiring oral or
intravenous antibiotics, except for prophylactic antibiotics;
- Patients with active tuberculosis infection by medical history or CT examination, or
active tuberculosis infection within 1 year prior to enrollment, or active
tuberculosis infection within 1 year before enrollment, or before enrollment but
without formal treatment;
- The presence of active hepatitis B (HBV DNA 2000 IU / mL or 104 copies / mL),
hepatitis C (hepatitis C antibody positive, and HCV RNA above the lower limit of the
analysis method);
- According to the investigator, there are other factors present that may lead to the
forced termination of the study, such as other serious illness (including mental
illness) requiring combined treatment, alcohol abuse, substance abuse, family or
social factors, that may affect the safety or compliance of the subject.
Gender:
All
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 30, 2024
Completion date:
September 30, 2027
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05628610
