Perioperative Therapy for HER2-negative Hepatoid Adenocarcinoma of Stomach

Recruiting now · Phase 2

Conditions studied: Hepatoid Adenocarcinoma of Stomach

In brief

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

Key facts

Study ID

NCT07178340

Run by

Peking University Cancer Hospital & Institute

People needed

30

Starts

2025-09-18

Expected to finish

2028-09-20

Last updated by the study team

2025-12-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The histological type of gastric hepatoid adenocarcinoma was confirmed by pathological biopsy；
• HER2 negative (Immunohistochemistry: 0);
• Patients with clinical stage II-III;
• Those who are expected to complete R0 excision;
• ECOG score 0\~1;
• Generally in good condition, perioperative treatment and surgical resection can be tolerated;
• Patients were enrolled voluntarily.

You may not qualify if…

• Combined with other malignant tumors (excluding thyroid papillary carcinoma, facial basal cell carcinoma and other low-grade malignant tumors); -Patients with obstruction, bleeding, etc. who need surgical intervention after evaluation by clinicians;
• dMMR/MSIH status；
• Received other anti-tumor therapy before enrollment.

Where it is running

• Peking University Cancer Hospital & Institute — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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