FLOT Combined With PD-1 in the First-line Treatment of Patients With Advanced Gastric Cancer and Peritoneal Metastasis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chemotherapy
- Gastric Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
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 cycles of FLOT regimen + teriprizumab treatment before surgery, and every 2 weeks is a treatment cycle ...
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 cycles of FLOT regimen + teriprizumab treatment before surgery, and every 2 weeks is a treatment cycle (Q2W). The specific plan is as follows. FLOT: Docetaxel 50mg/m2 ivd d1 + oxaliplatin 85mg/m2 ivd d1 + leucovorin 200mg/m2 ivd d1 + 5-FU 2600mg/m2 civ 24h Q2W Treprizumab 3mg/kg, intravenously administered on the first day of each cycle, Q2W If the transformation is successful, the patient undergoes R0 surgical resection of D2 lymph node dissection for gastric cancer in accordance with the "Japanese Gastric Cancer Treatment Guidelines. Physician's Edition. 4th Edition". After the operation, the patient will continue to receive 4 cycles of FLOT treatment + Teripril Anti-treatment, the treatment plan is the same as before. After completing the 4 cycles of treatment, oral Tiggio Capsule (S-1) and Teriprizumab were maintained for 1 year. The specific plan is as follows. Tiggio capsule (S-1) 40-60mg (BSA<1.25 m2: 40mg, 1.25 m2?BSA?1.5 m2: 50mg, BSA> 1.5 m2: 60mg) po bid d1-14 Q3W, continuous treatment for 1 year; Teriprizumab 240mg, intravenously, given on the first day of each cycle, Q3W, continuous treatment for 1 year.
Tracking Information
- NCT #
- NCT04886193
- Collaborators
- Shanghai Junshi Bioscience Co., Ltd.
- Investigators
- Not Provided