| Eligibility |
Inclusion Criteria:
- 1. The patient voluntarily participated in this study, signed an informed consent
form, had good compliance, and cooperated with follow-up; 2. Age 75 and above, both
male and female; 3. Patients with locally advanced esophageal squamous cell carcinoma
confirmed by histology and clinically classified as stage II-IVa that cannot be
surgically removed (including non resectable, contraindications to surgery, or refusal
to undergo surgery) (according to the 8th edition of AJCC staging, the pre-treatment
clinical staging is cT1N2-3M0, cT2-4bN0-3M0); 4. PDL1 detection result CPS = 1 5.
There are measurable and/or unmeasurable lesions that meet the criteria for evaluating
the efficacy of solid tumors (RECIST 1.1); 6. Have not received any systematic
anti-tumor treatment in the past (including but not limited to systemic chemotherapy,
radiotherapy, molecular targeted drug therapy, immunotherapy, biological therapy,
local treatment, and other research treatment drugs); 7. ECOG: 0-1 points (see
Attachment 1); 8. It is recommended to provide fresh or archived tumor tissue samples
within 6 months (fresh samples are preferred) for biomarker analysis (such as PD-L1).
The sample type is a formalin fixed, paraffin embedded [FFPE] tumor tissue block or at
least 5 unstained, 3-5 thick pieces µ FFPE tumor tissue slice of m; 9. Expected
survival time = 3 months; 10. The functions of important organs meet the following
requirements (no blood components or cell growth factors are allowed to be used 2
weeks before the start of screening examination): Absolute neutrophil count (ANC) =
1.5 × 109/L; Platelets = 100 × 109/L; Hemoglobin = 9g/dL; Serum albumin = 2.8g/dL;
Total bilirubin = 1.5 x ULN, ALT, AST, and/or AKP = 2.5 x ULN; Serum creatinine = 1.5
× ULN or creatinine clearance rate = 60mL/min (calculated according to Cockcroft Gault
formula, see Annex 2); International standardized ratio (INR) and activated partial
thromboplastin time (APTT) = 1.5 × ULN (for stable dose anticoagulant therapy such as
low molecular weight heparin or warfarin, and INR can be screened within the expected
therapeutic range of anticoagulants);
Exclusion Criteria:
- 1. History of esophageal cancer surgery; 2. Previous history of fistula caused by
primary tumor infiltration; 3. There is a higher risk of gastrointestinal bleeding,
esophageal fistula, or esophageal perforation; 4. Subjects with poor nutritional
status and a weight loss of = 10% within the first two months of screening showed no
significant improvement after management and intervention; 5. Has undergone major
surgery or had serious trauma within the first 4 weeks prior to the use of the
investigational drug; 6. There are uncontrollable pleural effusion, pericardial
effusion, or ascites that require repeated drainage; 7. Have received or are currently
receiving any of the following treatments in the past:
1. Anti PD-1 or anti PD-L1 antibody therapy, chemotherapy, radiotherapy, targeted
therapy;
2. Received any investigational medication within 4 weeks prior to the first use of
the investigational medication;
3. Subjects who require systemic treatment with corticosteroids (>10 mg prednisone
equivalent dose per day) or other immunosuppressants within 2 weeks prior to the
first use of the study drug are excluded from the use of corticosteroids for
local esophageal inflammation and prevention of allergies, nausea, and vomiting.
Other special circumstances require communication with the sponsor. In the
absence of active autoimmune diseases, it is allowed to inhale or locally use
steroids and adrenal cortex hormone replacement with a dose greater than 10mg/day
of prednisone efficacy dose;
4. Individuals who have received anti-tumor vaccines or have received live vaccines
within 4 weeks prior to the first administration of the investigational drug; 8.
Have any history of active autoimmune diseases or autoimmune diseases (such as
interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation,
vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); Excluding
patients with vitiligo or those who have recovered from asthma/allergies of the
same age and do not require any intervention in adulthood; Patients with
autoimmune mediated hypothyroidism treated with thyroid replacement hormone at a
stable dose and type I diabetes patients treated with insulin at a stable dose
can be included; 9. Have a history of immunodeficiency, including HIV testing
positive, or other acquired or congenital immunodeficiency diseases, or a history
of organ transplantation and allogeneic bone marrow transplantation; 10. Subjects
with uncontrolled clinical symptoms or diseases of the heart, such as (1) NYHA II
and above heart failure, (2) unstable angina, (3) myocardial infarction within 1
year, and (4) clinically significant supraventricular or ventricular arrhythmias
requiring clinical intervention; 11. Serious infections (CTC AE>Level 2) occurred
within 4 weeks prior to the first use of the investigational drug, such as severe
pneumonia, bacteremia, and infection complications that require hospitalization
treatment; Baseline chest imaging examination suggests the presence of active
pulmonary inflammation and symptoms and signs of infection within 2 weeks prior
to the first use of the study drug, requiring oral or intravenous antibiotic
treatment, except for prophylactic antibiotic use; 12. Have a history of
interstitial lung disease and non infectious pneumonia, and pulmonary function
tests confirm = grade 3 pulmonary insufficiency; 13. Patients who have been
diagnosed with active pulmonary tuberculosis infection through medical history or
CT examination, or have a history of active pulmonary tuberculosis infection
within one year before enrollment, or have a history of active pulmonary
tuberculosis infection more than one year before but have not received formal
treatment; 14. The subject has active hepatitis B (HBV DNA = 2000 IU/mL or 104
copies/mL), hepatitis C (hepatitis C antibody positive, and HCV RNA above the
detection limit of the analysis method); 15. There are abnormal laboratory test
values of sodium, potassium, and calcium greater than level 1 within the first
two weeks of enrollment, which cannot be improved after treatment; 16. Known
allergic reactions, hypersensitivity reactions, or contraindications to
macromolecular protein preparations, or any components of serplulimab, or to
paclitaxel or cisplatin or any components used in their preparations; 17.
Diagnosed as any other malignant tumor before the first use of the
investigational drug, excluding malignant tumors with low risk of metastasis and
death (5-year survival rate>90%), such as basal cell or squamous cell skin cancer
or cervical cancer in situ that has been adequately treated; 18. According to the
judgment of the researchers, the subjects may have other factors that may force
them to terminate the study midway, such as having other serious illnesses
(including mental illness) that require concurrent treatment, having other
serious illnesses (such as myocardial infarction, cerebrovascular accident) in
the near future, high risk of recurrence, severe abnormalities in laboratory test
values, family or social factors, which may affect the safety of the subjects or
the collection of trial data.
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