Trial Title:
Serplulimab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age
NCT ID:
NCT06354218
Condition:
Esophageal Carcinoma
Conditions: Official terms:
Esophageal Neoplasms
Conditions: Keywords:
Serplulimab
Concurrent chemoradiotherapy
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:
Serplulimab
Description:
Serplulimab （4.5mg/Kg every 3 weeks）
Arm group label:
Assigned Interventions
Other name:
HLX-10LX
Summary:
This study is a Single Arm, Prospective, Exploratory, Single Center Phase II Clinical
Study to evaluate the effectiveness of the combination of Serplulimab and Concurrent
Chemoradiotherapy in the treatment of elderly patients with locally advanced esophageal
cancer who cannot be treated surgically.Subjects can be enrolled into this study only if
they meet inclusion criteria and do not meet exclusion criteria.
Detailed description:
It is expected that 50 patients will be enrolled, and patients who meet the enrollment
criteria will undergo esophagoscopy, esophageal barium meal examination, chest
contrast-enhanced CT, abdominal ultrasound, electrocardiogram, blood routine, whole body
bone scan, liver and kidney function and other examinations before treatment, and
esophageal ultrasound if necessary. Patients who received esophageal ultrasound were
staged by esophageal ultrasound results, and those without esophageal ultrasound were
mainly staged according to the cervical chest and epigastric contrast CT and esophageal
barium plates, and clinical staging was performed according to the AJCC staging standard.
After the combination of Serplulimab and concurrent chemoradiotherapy, adverse reactions
and efficacy evaluation were observed. The expected result is that the local control rate
of Serplulimab combined with chemoradiotherapy is improved in patients with locally
advanced elderly esophageal squamous cell carcinoma, and there is no significant increase
in adverse reactions, and serological indicators such as PDL-1 CPS can be used as
prognostic indicators for esophageal malignancy and have certain guiding significance for
treatment. PD-1 monoclonal antibody can be used in locally advanced elderly esophageal
cancer patients who cannot tolerate chemotherapy, with good short-term efficacy and
tolerable toxic side effects, which further provides reference value for clinical
guidance.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
75 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Nanjing Medical University
Address:
City:
Nanjing
Zip:
210009
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaolin MM Ge, PHD
Phone:
13951818797
Email:
doctorsxl@163.com
Start date:
December 1, 2023
Completion date:
December 1, 2027
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06354218
