PD-1 Monoclonal Antibody Combined With FLOT Regimen for N... | NCT04341857

NCT04341857

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sintilimab combined with FLOT regimen	Experimental	Oxaliplatin#80mg/m2d1#iv infusion for 2 hours# Calcium leucovate#200mg/m2d1#iv infusion# Fluorouracil#2600mg/m2,intravenous drip for 24h# Docetaxel#50mg/m2,intravenous drip for 1 h# Every 14 days is one cycle# Sintilimab#200mg, d1#iv infusion Every 21 days is one cycle.	Drug: PD-1 Monoclonal Antibody(Sintilimab)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PD-1 Monoclonal Antibody(Sintilimab)	Drug	Sintilimab combined with FLOT regimen,Docetaxel#50mg/m2d1,iv infusion for 1 hour#,Oxaliplatin#80mg/m2d1#iv infusion for 2 hours#,Calcium,leucovate#200mg/m2d1#iv infusion# ,Fluorouracil#2600mg/m2,intravenous drip for 24h# Every 14 days is one cycle# Sintilimab#200mg, d1#iv infusion Every 21 days is one cycle.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pathological complete response (pCR) rate	Complete pathological response can be determined if no tumor lesion remains or only carcinoma in situ remains in the Complete pathological response can be determined if no tumor lesion remains or only carcinoma in situ remains in the Complete pathological response can be determined if no tumor lesion remains or only carcinoma in situ remains in the surgical specimens (see WHO solid tumor efficacy criteria	immediately after surgery

Secondary Outcomes

Measure	Description	Time Frame
Disease free survival(DFS)	The interval between the dates of the first dose of trial treatment until first documentation of disease progression or death, whichever occurs first. Patients with new non-breast cancer malignancy must continue to be followed for progression of the original breast cancer. For patients without progression, follow-up is censored at the date of last disease assessment without progression, unless death occurs within 12 weeks following the date last known progression-free, in which case the death will be counted as a DFS event.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.