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Trial Title:
Neoadjuvant Immunotherapy and Chemoradiotherapy for Locally Advanced Esophagogastric Junction Adenocarcinoma
NCT ID:
NCT05505461
Condition:
Adenocarcinoma of Esophagogastric Junction
Conditions: Official terms:
Adenocarcinoma
Antibodies
Conditions: Keywords:
PD-1, neoadjuvant therapy, radiotherapy
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:
neoadjuvant Radiation plus SOX and PD-1 antibody
Description:
Patients will be given the perioperative treatment as below once recruited:
First, neoradiation (5w) will be given: intensity modulated radiotherapy was given for
tumors and high-risk lymphatic drainage areas. PD-1 antibody will be started concurrent
the radiation for 2 cycles.
The neochemotherapy (SOX) and PD-1 antibody will be given for 2 cycles after 1 week since
radiation completed ; Patients will rest 2 weeks after the last cycle of neochemotherapy,
and evaluation will be performed during this time. And D2 surgery will be performed if
resectable.
SOX and PD-1 antibody will be given q3w. Adjuvant chemotherapy: We advise starting 4
cycles of SOX regimen in 3-8w after surgery.
Arm group label:
Neoadjuvant therpy
Other name:
Neoadjuvant Chemoradiotherapy plus Immunotherapy
Summary:
The purpose of this study was to evaluate the effect and safety of concurrent PD-1
antibody-based long-term radiotherapy followed by 2 cycles SOX with PD-1 in patients with
locally advanced adenocarcinoma of esophagogastric junction.
Detailed description:
The incidence of adenocarcinoma of the esophagogastric junction (AEG) is increasing in
Asian countries and Western Contries. Surgical resection is the most important treatment
for AEG. However, the recurrence rate is high when surgery is performed alone. The
results of CLASSIC, MAGIC, FLOT4, JCOG0501, PRODIGY, RESOLVE, CROSS trial showed that
perioperative chemotherapy and pre- or postoperative chemoradiotherapy significantly
increase the overall survival rate and disease free survival rate compared to surgery
alone. Radiotherapy and immunotherapy can increase sensitivity to each other, and several
clinical studies have also showed that PD-1 antibody may significantly prolongs the
life.Thus the investigators plan to conduct this clinical trial to evaluate the effect
and safety of concurrent PD-1 antibody-based long-term radiotherapy followed by 2 cycles
SOX with PD-1 in patients with locally advanced adenocarcinoma of esophagogastric
junction.
Subjects will receive long-term radiotherapy (5w) concurrent with PD-1 antibody for 2
cycles, then receive two cycles of SOX regimen combined PD-1 after a week's rest. Surgery
will be performed 2 weeks after the last cycle of neoadjuvant treatment. Adjuvant
treatment will be started 3 to 8 weeks after surgery, and SOX regimen will be given for 4
cycles.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologically confirmed adenocarcinoma of esophagogastric junction, and Her-2
negative.
2. Clinically diagnosed stage T3+orN+M0, according to CT/MRI scan.
3. No prior anti-tumor treatment, including surgery, chemotherapy, radiotherapy, and
targeted therapy.
4. Eastern Cooperative Oncology Group(ECOG) performance status(PS) 0-1.
5. At least one evaluable lesion in abdominal CT/MRI according to RESIST 1.1 is
required.
6. Expected survival ≥6 months.
7. Adequate organ function, Hemoglobin ≥90g/L; White blood cells ≥3.0×109/L; neutrophil
count ≥1.5×109/L; Platelets ≥100×109/L; Serum creatinine (SCr) ≤ 1.5 times the upper
limit of normal (ULN) or creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault
formula); Total bilirubin (TBIL) ≤ 1.5 times the ULN; Aspartate aminotransferase
(AST) or alanine aminotransferase (ALT) level ≤ 2.5 times the ULN; Urine protein <
2+; if urine protein ≥ 2+, 24-hour urine protein quantification shows that protein
must be ≤ 1 g.
8. Normal coagulation function, no active bleeding and thrombotic diseases:
International Standardized Ratio INR≤1.5×ULN; Partial thromboplastin time
APTT≤1.5×ULN; Prothrombin time PT≤1.5ULN;
9. Previous use of anti-tumor Chinese medicines, proprietary Chinese medicines, and
immunomodulators (such as thymosin, interleukin, etc.) must be ≥ 2 weeks from the
start of the study medication;
10. Female patients should not be pregnant or breast feeding. Male should contraception.
11. Able and willing to give informed consent to participate.
12. Those who are expected to have good compliance.
Exclusion Criteria:
1. Existence of other active malignant tumors within 5 years or at the same time.
2. Already received chemotherapy, radiation therapy, targeted or immunotherapy.
3. Have any active autoimmune disease or history of autoimmune disease.
4. Patients with congenital or acquired immunodeficiency.
5. Use of immunosuppressive drugs within 14 days before the study start.
6. Administer live attenuated vaccines within 4 weeks before the study start.
7. Suffering from uncontrolled cardiac clinical symptoms or diseases, such as (1) NYHA
II and above heart failure (2) unstable angina pectoris (3) myocardial infarction
within 1 year (4) poorly controlled arrhythmia.
8. Patients with past and current interstitial pneumonia, pneumoconiosis, radiation
pneumonia, drug-related pneumonia, etc., and severely impaired lung function.
9. Suffering from active pulmonary tuberculosis.
10. Complicated severe infection within 4 weeks before the the study start, or
unexplained fever >38.5°C during the screening period/before the study start.
11. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem
cell transplantation.
13. Allergic to any drug in this study. 14. Combined with other severe, acute and
chronic diseases that may increase the risk of participating.
15.Participators who had been recruited by other clinical trial within three months.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Zip:
100044
Country:
China
Contact:
Last name:
Liyu Zhu
Phone:
+8610-66583821
Email:
wcwkzlward@163.com
Start date:
January 2023
Completion date:
December 2027
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05505461