Perioperative RC48 (Disitamab Vedotin) with sindillizumab and SOX for HER2‑expressing hepatoid stomach cancer
Official title: Prospective, Single-arm, Single-center Phase II Clinical Study of Perioperative Precision Treatment for Locally Advanced Hepatoid Adenocarcinoma of Stomach
Run by Peking University Cancer Hospital & Institute · NCT06992362 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Drugs / interventions | Disitamab, Sindillimab, sindillizumab |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | May 20, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2029 |
| Registry record updated | September 22, 2026 |
| Trial ID | NCT06992362 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Perioperative albumin-bound paclitaxel plus SOX chemotherapy with sintilimab for HER2-negative hepatoid stomach cancer
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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.