Phase II Clinical Study of PD-1 Monoclonal Antibody (Sintilimab) Combined With FLOT Regimen for Neoadjuvant Therapy of Gastric Adenocarcinoma/ Esophagogastric Junction Adenocarcinoma
Overview
- Phase
- Phase 2
- Intervention
- PD-1 Monoclonal Antibody(Sintilimab)
- Conditions
- Gastric and Esophagogastric Junction Adenocarcinoma
- Sponsor
- Henan Cancer Hospital
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Pathological complete response (pCR) rate
- Last Updated
- 4 years ago
Overview
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 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.
Investigators
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;
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;
Arms & Interventions
Sintilimab combined with FLOT regimen
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.
Intervention: PD-1 Monoclonal Antibody(Sintilimab)
Outcomes
Primary Outcomes
Pathological complete response (pCR) rate
Time Frame: immediately after surgery
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
Secondary Outcomes
- Disease free survival(DFS)(From the date of first treatment dose until documented disease progression or death from any cause. whichever occur first, assessed up to 30 months)