Trial Title:
A Study of Adebrelimab Combined With Chemoradiotherapy in the Treatment of Esophageal Small Cell Carcinoma
NCT ID:
NCT06478264
Condition:
Esophageal Small Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Carboplatin
Etoposide
Conditions: Keywords:
Esophageal Small Cell Carcinoma
Adebrelimab
chemoradiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Etoposide
Description:
100mg/m^2, intravenous infusion for 1-3 days,21 days/cycle, 4 cycles
Arm group label:
Single arm
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
25mg/m^2 ,intravenous infusion for 1-3 days ,21 days/cycle, 4 cycles
Arm group label:
Single arm
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin (AUC = 5) on 1 Day,21 days/cycle, 4 cycles ;
Arm group label:
Single arm
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
1200mg adebrelimab was given intravenously on 2 day after chemotherapy,21 days/cycle,
continuous use.
Arm group label:
Single arm
Other name:
SHR-1316
Intervention type:
Radiation
Intervention name:
radiotherapy
Description:
Stage I-IVa , prescription dose: PTV 50Gy/25f. Stage IVb ,prescribed dose: PTV 30Gy/10f.
Arm group label:
Single arm
Summary:
To evaluate the efficacy and safety of adebrelimab combined with chemoradiotherapy in the
treatment of esophageal small cell carcinoma
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Sign a written informed consent to join the study voluntarily;
-
2. Histologically or cytologically confirmed patients with small cell carcinoma of
the esophagus staging T1N0M0 but unable to tolerate surgery or refusing surgery
and patients staging T2-4N0-3M0 [according to AJCC 8th edition TNM criteria];
-
3. Age 18-75 years old, male or female;
-
4. ECOG PS 0-1;
-
5. No previous systemic treatment for esophageal small cell carcinoma;
-
6. At least one measurable lesion (according to RECIST1.1 criteria);
-
7. Normal functioning of major organs, including:
1. Blood routine examination (no blood component, cell growth factor, white
enhancer, platelet enhancer, anemia correction drugs are allowed within 14 days
before the first use of the study drug) :
White blood cell count ≥4.0×10^9/L
Neutrophil count ≥1.5×10^9/L
Platelet count ≥80×10^9/L
Hemoglobin ≥90 g/L
2. Blood biochemical examination:
Total bilirubin ≤1.5×ULN
ALT≤2.5 x ULN, AST≤2.5 x ULN,
Serum creatinine ≤1.5×ULN, or creatinine clearance ≥50mL/min (Cocheroft-Gault
formula, see Annex 2)
3. Coagulation function:
International Standardized ratio (INR) ≤1.5×ULN
Activated partial thromboplastin time (APTT) ≤1.5×ULN
-
8. Patients must submit pre-treatment tumor tissue samples during the study
period;
-
9. Expected survival ≥12 weeks;
-
10. Fertile female subjects are required to take a serum or urine pregnancy test
with a negative result within 72 hours before starting the study drug
administration, and to use effective contraception (such as an IUD,
contraceptive pill or condom) during the trial period and for at least 3 months
after the last drug administration; For male subjects whose partners are women
of reproductive age, effective contraception should be used during the trial
period and within 3 months after the last dose;
-
11. The subjects had good compliance and cooperated with follow-up visits.
Exclusion Criteria:
-
1. Esophageal perforation or hematemesis;
-
2. Uncontrolled pleural effusion, pericardial effusion or ascites requiring
repeated drainage;
-
3. Uncontrolled hypercalcemia or symptomatic hypercalcemia;
-
4. Other malignancies diagnosed within 5 years prior to the first use of the
investigational drug, except malignancies with a low risk of metastasis or
death (5-year survival > 90%), such as adequately treated skin basal cell
carcinoma or squamous cell skin cancer or cervical carcinoma in situ, may be
considered for inclusion;
-
5. History of any active autoimmune disease or autoimmune disease, including but
not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis,
vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered after
hormone replacement therapy); Patients with psoriasis or childhood
asthma/allergies in complete remission without any intervention as adults may
be considered for inclusion, but patients requiring medical intervention with
bronchodilators may not be included;
-
6. Previously received immune checkpoint blocking therapy;
-
7. Subjects who required systemic corticosteroids (> 10 mg/ day effective dose of
prednisone) or other immunosuppressive agents within 14 days prior to initial
dosing or during the study period. However, in the absence of active autoimmune
disease, subjects were allowed to use topical or inhaled steroids and adrenal
hormone replacement therapy at a dose ≤10 mg/ day of prednisone effectiveness.
-
8. There are clinical symptoms or diseases of heart that are not well controlled,
including but not limited to: (1) NYHA grade II or above heart failure, (2)
unstable angina pectoris, (3) myocardial infarction within 1 year, (4)
Clinically significant supraventricular or ventricular arrhythmias that are not
well controlled without or after clinical intervention;
-
9. Poor nutritional status, BMI < 18.5 Kg/m^2; If it is corrected before
enrollment after symptomatic nutritional support, it can continue to be
considered for enrollment after evaluation by the principal investigator;
-
10. Adverse events greater than grade 2 caused by treatment received before the
first use of the investigatory drug that have not recovered (i.e., become grade
1 or reach baseline level), and adverse events (such as neurotoxicity) that are
difficult to recover quickly as determined by the investigator can be included;
-
11. History of allergy to any component of adbelimab, etoposide, cisplatin or
carboplatin;
-
12. A history of immunodeficiency, including HIV testing positive, or other
acquired or congenital immunodeficiency diseases, or a history of organ
transplantation or allogeneic bone marrow transplantation;
-
13. Severe infections (CTCAE > Grade 2), such as severe pneumonia requiring
hospitalization, bacteremia, and infection complications, occurred within 4
weeks prior to the first use of the study drug; Baseline chest imaging
indicated active pulmonary inflammation, signs and symptoms of infection within
14 days prior to the first use of the study drug, or the need for oral or
intravenous antibiotic treatment, except in cases of prophylactic antibiotic
use;
-
14. Patients found to have active pulmonary tuberculosis infection through medical
history or CT examination, or had a history of active pulmonary tuberculosis
infection within 1 year before enrollment, or had a history of active pulmonary
tuberculosis infection more than 1 year ago without formal treatment;
-
15. Hereditary bleeding tendency or blood clotting dysfunction. There were
clinically significant bleeding symptoms or definite bleeding tendencies within
3 months prior to enrollment, such as hemorrhagic gastric ulcer, stool occult
blood ++ or above at baseline;
-
16. Active hepatitis B (HBV DNA≥2000 IU/mL or 10^4 copies/mL), hepatitis C
(hepatitis C antibody positive and HCV RNA higher than the lower limit of
assay);
-
17. Pregnant or lactating women;
-
18. The investigator determined that there were other factors that might have led
to the forced termination of the study, such as other serious medical
conditions (including mental illness) requiring co-treatment, alcohol,
substance abuse, family or social factors, and factors that might have affected
the safety or adherence of the subjects.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
July 13, 2024
Completion date:
July 13, 2027
Lead sponsor:
Agency:
Zhangzhou Municipal Hospital
Agency class:
Other
Source:
Zhangzhou Municipal Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06478264
