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Perioperative Therapy for HER2-negative Hepatoid Adenocarcinoma of Stomach
Sponsor: Peking University Cancer Hospital & Institute
Summary
The goal of this clinical trial is to learn if treatment modality including albumin-bound paclitaxel, oxaliplatin, tegafur,gimeracil and oteracil porassium capsules (SOX) and sintilimab works to treat locally advanced HER2-negative hepatoid adenocarcinoma of stomach. It will also learn about the safety of this modality. The main aim it aims to achieve are: * To evaluate the perioperative efficacy of albumin-bound paclitaxel combined with sintilimab and SOX in the treatment of locally advanced HER2-negative hepatoid adenocarcinoma of stomach * To evaluate the safety and long-term benefits of albumin-bound paclitaxel combined with sintilimab and SOX regimens in perioperative treatment of locally advanced HER2-negative hepatoid adenocarcinoma of stomach Participants will: * Preoperative treatment with abumin-bound paclitaxel, SOX and sintilimab for 4 cycles * Radical surgery after 4-6 weeks of the preoperative treatment * Adjuvant treatment with albumin-bound paclitaxel, tegafur,gimeracil and oteracil porassium capsules and sintilimab for 4 cycles
Official title: Prospective, Single-arm, Single-center Phase II Clinical Study of Perioperative Therapy for Locally Advanced HER2-negative Hepatoid Adenocarcinoma of Stomach
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-09-18
Completion Date
2028-09-20
Last Updated
2025-12-02
Healthy Volunteers
No
Conditions
Interventions
Perioperative treatment with albumin-bound paclitaxel, oxaliplatin, tegafur,gimeracil and oteracil porassium capsules and sintilimab.
1. Neoadjuvant therapy for 4 cycles: albumin-bound paclitaxel 150mg/m2, intravenously, d1, a course of treatment every 21 days; sintilimab 200mg, intravenously, d1, every 21 days; tegafur,gimeracil and oteracil porassium (by body surface area: BSA\<1.25m2, 40mg; BSA≥1.25m2, \<1.5m2, 50mg; BSA≥1.5m2,60mg), orally, twice a day, d1-14, every 21 days; oxaliplatin 85mg/m2, intravenously, d1, every 21 days. 2. Radical surgical treatment should be performed within 4-6 weeks after the end of neoadjuvant therapy. 3. Adjuvant therapy for 4 cycles: albumin-bound paclitaxel 125mg/m2, intravenously, d1, a course of treatment every 21 days; sintilimab 200mg, intravenously, d1, every 21 days; tegafur,gimeracil and oteracil porassium (by body surface area: BSA\<1.25m2, 40mg; BSA≥1.25m2, \<1.5m2, 50mg; BSA≥1.5m2,60mg), orally, twice a day, d1-14, every 21 days.
Locations (1)
Peking University Cancer Hospital & Institute
Beijing, China