Status:
UNKNOWN
PD-1 Monoclonal Antibody Combined With FLOT Regimen for Neoadjuvant Therapy of Gastric Adenocarcinoma
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Gastric and Esophagogastric Junction Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a prospective single arm phase II clinical study to compare the safety and efficacy of PD-1monoclonal antibody +FLOT in patients with gastric adenocarcinoma/esophagus-gastric junction adenocar...
Detailed Description
Into a set of 25 cases of the gastric carcinoma confirmed by pathology or gastroesophageal junction adenocarcinoma (cT4 and/or N + M0, Multi-Disciplinary Team thought line to perioperative treatment) ...
Eligibility Criteria
Inclusion
- Informed consent has been signed;
- Only patients aged 18-75 were enrolled;
- Pathologically confirmed gastric adenocarcinoma (cT4 or/and N+M0, MDT considers perioperative treatment necessary) :Bone scan should be performed if bone metastasis is suspected.If peritoneal metastasis is suspected, laparoscopy should be performed;
- No previous cytotoxic chemotherapy or targeted therapy;
- No previous local resection of the tumor;
- ECOG 1 or less;
- Tumor specimens capable of detecting PDL-1 and MSI status are available.The detection of PDL-1 and MSI will be conducted after random grouping.This test requires the patient to provide a paraffin-embedded biopsy specimen;
- Leukocyte ≥ 4×109/L, platelet ≥ 100×109/L without transfusion, absolute value of neutrophils (ANC) without granulocyte stimulation factor ≥ 1.5×109/L, and hemoglobin≥ 90 g/L;
- Bilirubin ≤ 1.5 times of the upper limit of normal value, and rice grass and rice propyl transaminase ≤ 2.5 times of the upper limit of normal value;
- Serum creatinine ≤ 1.5 times the upper limit of normal value, or GFR\>45ml/min;
- Serum albumin ≥ 25g /L (2.5g /dL);
- INR or aPTT ≤1.5 times ULN;
Exclusion
- Allergy to any experimental drug and its excipients, or a history of severe allergy, or a contraindication to the experimental drug;
- Ahistory of autoimmune diseases or active stage;
- Previous allogeneic bone marrow transplantation or organ transplantation;
- Congenital pulmonary fibrosis, drug-induced pneumonia, organized pneumonia, or ct-confirmed active pneumonia;
- HIV test positive;
- Active hepatitis b or c;
- Active tuberculosis;
- Uncontrolled cancer pain;
- Live attenuated vaccine was injected within 4 weeks before the study began, or live attenuated vaccine was expected to be injected during the trial or within 5 months after the trial;
- Previous immunotherapy, including CTLA4, anti-pd-1, or anti-pdl1 monoclonal antibody;
- CT suggested active pulmonary inflammation;
- Systemic application of glucocorticoids or immunosuppressants within 2 weeks before the start of the trial.Inhaled glucocorticoids and glucocorticoids are allowed;
- There are taboos on hormone use;
- Severe cardiovascular disease, myocardial infection or cerebrovascular accident, arrhythmia, unstable angina within 3 months before the start of the trial;
- Uncontrolled increase in blood pressure or blood sugar;
- Other malignancies prior to 5 years, with the exception of cervical carcinoma in situ, non-melanoma skin cancer, or stage I uterine cancer;
- Known central nervous system metastases;
- Peripheral neuropathy ≥ NCI CTCAE grade 2;
- Serum albumin below 2.5 g/dL;
- Uncontrolled or symptomatic hypercalcemia;
- Infections requiring antibiotics within 14 days prior to the start of the trial;
- Chronic enteritis;
- Clinically significant active gastrointestinal bleeding;
- Non-diagnostic surgery within 4 weeks before the start of the trial;
- Any other disease where there is evidence of a need to restrict the use of the experimental drug;
- Participate in other tests within 30 days before the start of the test, or plan to participate in other tests during the test;
- Receive other experimental drugs within 28 days prior to the start of the trial;
- Pregnantor lactating women, or women who plan to become pregnant within 5months after the end of treatment.Women of childbearing age should undergo a blood pregnancy test within 7 days of the start of the trial.
Key Trial Info
Start Date :
July 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04341857
Start Date
July 30 2019
End Date
July 30 2022
Last Update
August 24 2021
Active Locations (1)
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1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008