Perioperative albumin-bound paclitaxel plus SOX chemotherapy with sintilimab for HER2-negative hepatoid stomach cancer

Prospective, Single-arm, Single-center Phase II Clinical Study of Perioperative Therapy for Locally Advanced HER2-negative Hepatoid Adenocarcinoma of Stomach

This trial will try giving pre- and post-surgery chemo (albumin-bound paclitaxel and SOX) together with the immunotherapy drug sintilimab to people with locally advanced HER2-negative hepatoid stomach cancer to see if it shrinks tumors and improves outcomes.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking University Cancer Hospital & Institute (other)
• Drugs / interventions: sintilimab
• Locations: 1 site (Beijing)
• Trial ID: NCT07178340 on ClinicalTrials.gov

What this trial studies

Patients with locally advanced (stage II-III) HER2-negative hepatoid adenocarcinoma of the stomach will receive four cycles of preoperative therapy combining albumin-bound paclitaxel, SOX (oxaliplatin plus tegafur/gimeracil/oteracil), and the PD-1 inhibitor sintilimab. If tumors are resectable, radical surgery is planned about 4–6 weeks after the preoperative treatment, followed by adjuvant therapy with the chemotherapy regimen. The trial will monitor perioperative safety, pathological response, and longer-term outcomes such as recurrence-free survival. Key enrollment criteria include HER2 IHC 0, ECOG 0–1, and an expectation of R0 resection, while patients with dMMR/MSI-H, prior systemic therapy, or other active malignancies are excluded.

Who should consider this trial

Good fit: Adults with histologically confirmed hepatoid adenocarcinoma of the stomach that is HER2-negative (IHC 0), clinical stage II–III, fit for perioperative therapy and R0 resection, and with ECOG performance 0–1 are ideal candidates.

Not a fit: Patients with HER2-positive tumors, metastatic disease, dMMR/MSI-H status, poor performance status, prior anti-tumor systemic therapy, or other active malignancies are unlikely to benefit from this perioperative regimen.

Why it matters

Potential benefit: If successful, this approach could increase tumor shrinkage before surgery and reduce recurrence risk, improving long-term outcomes for this aggressive gastric cancer subtype.

How similar studies have performed: Combining PD-1 inhibitors with chemotherapy has shown benefits in some gastric cancers, but applying this perioperative combination specifically to HER2-negative hepatoid adenocarcinoma is largely novel and not yet proven.

Eligibility criteria

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.

Where this trial is running

Beijing

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

Study contacts

• Principal investigator: Jiafu Ji, MD — Peking University Cancer Hospital & Institute
• Study coordinator: Anqiang Wang, MD

Conditions: Hepatoid Adenocarcinoma of Stomach, HER2, SOX, PD-1 inhibitor, perioperative treatment