Perioperative RC48 (Disitamab Vedotin) with sindillizumab and SOX for HER2‑expressing hepatoid stomach cancer
Prospective, Single-arm, Single-center Phase II Clinical Study of Perioperative Precision Treatment for Locally Advanced Hepatoid Adenocarcinoma of Stomach
This trial tests whether giving Disitamab Vedotin (RC48) together with sindillizumab and SOX chemotherapy before and after surgery helps people with locally advanced HER2‑expressing hepatoid stomach cancer and is safe.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Drugs / interventions | Disitamab, Sindillimab, sindillizumab |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06992362 on ClinicalTrials.gov |
What this trial studies
This is a phase II, single‑center trial at Peking University Cancer Hospital testing a perioperative regimen of RC48, sindillizumab, and SOX chemotherapy for locally advanced HER2‑expressing hepatoid adenocarcinoma of the stomach. Participants receive four cycles of the combination before planned radical surgery, followed by surgery 4–6 weeks after preoperative therapy and four additional cycles of adjuvant RC48 plus oral tegafur/gimeracil/oteracil and sindillizumab. The trial aims to measure perioperative efficacy (including pathological response) and to monitor safety and longer‑term outcomes after R0 resection. Eligibility focuses on clinical stage II–III disease, HER2 expression by IHC, good performance status, and no prior anti‑tumor therapy.
Who should consider this trial
Good fit: Ideal candidates are people with histologically confirmed hepatoid gastric adenocarcinoma, HER2 IHC 1+–3+, clinical stage II–III, ECOG 0–1, who can tolerate perioperative therapy and are expected to undergo R0 resection.
Not a fit: Patients with other active malignancies, urgent surgical complications (obstruction or bleeding), dMMR/MSI‑H tumors, prior anti‑tumor therapy, or poor performance status are unlikely to benefit from this regimen.
Why it matters
Potential benefit: If successful, this regimen could increase the chance of a complete tumor response before surgery and improve long‑term outcomes for this aggressive subtype.
How similar studies have performed: HER2‑targeted antibody‑drug conjugates and PD‑1 inhibitors have shown activity in gastric cancer, but using RC48 with sindillizumab in the perioperative setting for hepatoid adenocarcinoma is relatively novel and not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
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
- Email: wanganqiang0902@163.com
- Phone: 861088196970
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.