Perioperative Treatment of Hepatoid Adenocarcinoma of Stomach

NCT06992362 · tracked via the Priya Life Science China tracker

Sponsor

Peking University Cancer Hospital & Institute

Phase

Phase 2

Started

2025-05-20

Last updated

2025-09-16

Condition(s) studied

Hepatoid Adenocarcinoma of Stomach

Investigational drug(s) / intervention(s)

Perioperative treatment

Perioperative treatment: RC48+SOX+Sindilizumab

Study summary

The goal of this clinical trial is to learn if treatment modality including Disitamab Vedotin （RC48）, Oxaliplatin，Tegafur,Gimeracil and Oteracil Porassium Capsules （SOX）and Sindillimab works to treat locally advanced 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 RC48 combined with sindillizumab and SOX in the treatment of locally advanced HER2-expressing hepatoid adenocarcinoma of stomach
* To evaluate the safety and long-term benefits of RC48 combined with sindillizumab and SOX regimens in perioperative treatment of locally advanced HER2-expressing hepatoid adenocarcinoma of stomach

Participants will:

* Preoperative treatment with RC48, SOX and sindillizumab for 4 cycles
* Radical surgery after 4-6 weeks of the preoperative treatment
* Adjuvant treatment with RC48, Tegafur,Gimeracil and Oteracil Porassium Capsules and sindillizumab for 4 cycles

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * The histological type of gastric hepatoid adenocarcinoma was confirmed by pathological biopsy； * HER2 expression (Immunohistochemistry: 1+,2+,3+); * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

pathological complete response rate — within 10 days after surgery
The proportion of subjects with node-negative lymph nodes and without residual viable tumor cells in the total number of subjects

Trial sites (1)

Facility	City	Region	Status
Peking University Cancer Hospital & Institute	Beijing	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06992362 on ClinicalTrials.gov ↗ ← All trials in China