Perioperative Treatment of Hepatoid Adenocarcinoma of Stomach
NCT ID: NCT06992362
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2025-05-20
2029-12-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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perioperative treatment for hepatoid adenocarcinoma of stomach
1. Neoadjuvant therapy: Disitamab Vedotin 2.5mg/kg, d1, a course of treatment every 21 days; Sindilizumab 200mg intravenously, d1, every 21 days; Tegafur,Gimeracil and Oteracil Porassium Capsules (by body surface area: BSA\<1.25m2, 40mg; BSA≥1.25m2, \<1.5m2, 50mg; BSA≥1.5m2,60mg), orally, twice a day, d1-14, every 21 days; Oxaliplatin 85mg/m2, IV, d1, every 21 days.
2. Radical surgical treatment should be performed within 4-6 weeks after the end of neoadjuvant therapy.
3. Adjuvant therapy: Adjuvant therapy begins within 4-6 weeks after surgery. Disitamab Vedotin 2.5mg/kg intravenously, d1, one course every 21 days; Sindilizumab 200mg intravenously, d1, every 21 days; Tegafur,Gimeracil and Oteracil Porassium (by body surface area:BSA\<1.25m2, 40mg; BSA≥1.25m2, \<1.5m2, 50mg; BSA≥1.5m2,60mg) orally, 2 times daily, d1-14, one course every 21 days.
Perioperative treatment
RC48+SOX+Sindilizumab
Interventions
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Perioperative treatment
RC48+SOX+Sindilizumab
Eligibility Criteria
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Inclusion Criteria
* 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
* dMMR/MSIH status；
* Received other anti-tumor therapy before enrollment.
18 Years
75 Years
ALL
No
Sponsors
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Peking University Cancer Hospital & Institute
OTHER
Responsible Party
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Principal Investigators
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jiafu ji, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Peking University Cancer Hospital & Institute
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LGH2024296
Identifier Type: -
Identifier Source: org_study_id
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