PD-1 Monoclonal Antibody Combined With FLOT Regimen for Neoadjuvant Therapy of Gastric Adenocarcinoma

Phase II Clinical Study of PD-1 Monoclonal Antibody (Sintilimab) Combined With FLOT Regimen for Neoadjuvant Therapy of Gastric Adenocarcinoma/ Esophagogastric Junction Adenocarcinoma

NCT04341857•Henan Cancer Hospital

View on ClinicalTrials.gov

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 adenocarcinoma.

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) patients, preoperative accept four cycle by bead a resistance + sintilimab + capecitabine plus oxaliplatin into new adjuvant chemotherapy, because PD1 antibodies distance between surgery time interval is the lack of clinical data, judging by the researchers is 4 cycles of chemotherapy combination of sintilimab .The patient was able to undergo D2 radical surgery.Pathological examination was carried out to observe the pCR and the infiltration rate of immune cells.After the operation, patients continued to receive 4 cycles of capecitabine + oxaliplatin adjuvant therapy, and the total number of chemotherapy cycles was 8 cycles.Disease-free survival time and safety of treatment were observed, and OS, ORR and quality of life of all patients were followed up.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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;
+2 more criteria

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;
+18 more criteria

Locations (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

Key Dates

Start Date

July 30, 2019

Primary Completion Date

May 30, 2022

Completion Date

July 30, 2022

Last Updated

August 24, 2021

Enrollment

ESTIMATED participants

Conditions

Gastric and Esophagogastric Junction Adenocarcinoma

Interventions

PD-1 Monoclonal Antibody(Sintilimab)

DRUG

Contacts

Jing Ding, MD

CONTACT

13526501903 lining97@126.com