Status:
UNKNOWN
Toripalimab Combined With FLOT Neoadjuvant Chemotherapy in Patients With Resectable Gastric Cancer
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Gastric cancer is one of the most common malignant tumors of the digestive tract. Gastric cancer patients diagnosed for the first time in China have a higher proportion of advanced stages and a higher...
Detailed Description
Gastric cancer is one of the most common malignant tumors of the digestive tract, accounting for the second incidence of malignant tumors, and the third mortality factor related to malignant tumors. I...
Eligibility Criteria
Inclusion
- locally advanced (\>T1) and/or nodal positive (N+) histologically proven adenocarcinoma of the gastric or gastroesophageal junction without distant metastases (M0)
- no previous surgical resection
- no previous cytostatic chemotherapy
- Age \> 18 years, no more than 75 years (female and male)
- Karnofsky Performance Status score of physical condition is 80-100
- surgical resectability
- Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy
- Leucocytes \> 4.000/µl
- Platelets \> 100.000/µl
- Serum creatinin ≤ 1.5x of normal value, or Creatinin-Clearance \> 50 ml/min
- written informed consent.
Exclusion
- Distant metastasis or local invasion of adjacent organs;
- Recurrent or residual gastric cancer;
- Having or having had autoimmune disease;
- Previous organ transplantation or HIV patients;
- Allergy or contraindications to Toripalimab, 5- Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel;
- Malignant secondary disease;
- Severe non-surgical disease or acute infection;
- Peripheral polyneuropathy \> NCI grad I;
- Blood system, liver and kidney function were damaged;
- Symptomatic brain metastasis;
- Obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency and severe gravity valve disease;
- Psychotic subjects who are not easy to control;
- Pregnant or lactating subjects.
Key Trial Info
Start Date :
September 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04354662
Start Date
September 26 2019
End Date
June 30 2024
Last Update
February 18 2021
Active Locations (1)
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1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060