NCT06992362 Perioperative Treatment of Hepatoid Adenocarcinoma of Stomach
| NCT ID | NCT06992362 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking University Cancer Hospital & Institute |
| Condition | Hepatoid Adenocarcinoma of Stomach |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-05-20 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-05-20 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Frequently Asked Questions
Who can join the NCT06992362 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hepatoid Adenocarcinoma of Stomach. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06992362 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06992362 currently recruiting?
Yes, NCT06992362 is actively recruiting participants. Visit ClinicalTrials.gov or contact Peking University Cancer Hospital & Institute to inquire about joining.
Where is the NCT06992362 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06992362 clinical trial?
NCT06992362 is sponsored by Peking University Cancer Hospital & Institute. The trial plans to enroll 30 participants.