Status:
UNKNOWN
FLOT Combined With PD-1 in the First-line Treatment of Patients With Advanced Gastric Cancer and Peritoneal Metastasis
Lead Sponsor:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborating Sponsors:
Shanghai Junshi Bioscience Co., Ltd.
Conditions:
Chemotherapy
Gastric Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
In this study, patients with advanced gastric adenocarcinoma whose peritoneal metastasis and peritoneal nodule pathologically confirmed metastasis and/or exfoliative cytology were confirmed as the cli...
Detailed Description
The study drugs in this study are docetaxel, oxaliplatin, 5-FU, leucovorin, tigio capsules and teriprizumab. Dosage and dosing regimen for all research phases: The enrolled patients will receive 4 c...
Eligibility Criteria
Inclusion
- Informed consent of the patient;
- 18 years old \<age \<80 years old;
- The primary gastric lesion was diagnosed as gastric adenocarcinoma by endoscopic biopsy histopathology (papillary adenocarcinoma pap, tubular adenocarcinoma tub, mucinous adenocarcinoma muc, signet ring cell carcinoma sig, poorly differentiated adenocarcinoma por);
- The clinical stage of laparoscopic exploration is peritoneal metastasis, peritoneal nodule pathologically confirmed metastasis and/or exfoliated cytology test positive for advanced gastric cancer patients;
- Preoperative ECOG \[Using the ECOG scoring standard Zubrod-ECOG-WHO (ZPS, 5-point method) developed by the Eastern Cooperative Oncology Group (ECOG)\] Physical State Score 0/1;
- Preoperative anesthesia risk score sheet (ASA score sheet) I-III;
Exclusion
- The pathology of the peritoneal nodule confirmed no metastasis, and the exfoliated cytology test was negative;
- Pregnant or lactating women;
- Suffer from severe mental illness;
- Preoperative imaging or intraoperative exploration revealed that there have been distant blood metastases in the liver, lungs, and brain;
- A history of other malignant diseases within 5 years;
- A history of allergies to any component of teriprizumab, docetaxel, oxaliplatin, and fluorouracil;
- A history of continuous systemic corticosteroid therapy within 1 month;
- Complications of gastric cancer (bleeding, perforation, obstruction) requiring emergency surgery;
- A history of unstable angina or myocardial infarction, or a history of cerebral infarction or cerebral hemorrhage within 6 months, and a lung function test FEV1 \<50% of the expected value;
- Have received any of the following treatments:
- Have received anti-PD-1 or anti-PD-L1 antibody therapy in the past;
- Have received any investigational drug treatment within 4 weeks before using the drug for the first time;
- Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up;
- Receive the last dose of anti-cancer treatment (including radiotherapy) within 4 weeks before the first use of the study drug;
- Those who have been vaccinated with anti-tumor vaccines or the study drugs have been vaccinated with live vaccines within 4 weeks before the first administration;
- Those who have undergone major surgery or trauma within 4 weeks before using the study drug for the first time.
Key Trial Info
Start Date :
April 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04886193
Start Date
April 16 2021
End Date
May 1 2023
Last Update
May 13 2021
Active Locations (1)
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1
Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China, 510120