Perioperative Therapy for HER2-negative Hepatoid Adenocarcinoma of Stomach (HASCHANGE02)

Peking University Cancer Hospital & Institute

Status and phase

Enrolling

Phase 2

Conditions

Hepatoid Adenocarcinoma of Stomach

Treatments

Drug: Perioperative treatment with albumin-bound paclitaxel, oxaliplatin, tegafur,gimeracil and oteracil porassium capsules and sintilimab.

Study type

Interventional

Funder types

Other

Identifiers

NCT07178340

LGH2025138

Details and patient eligibility

About

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

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

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.