Perioperative Treatment of Hepatoid Adenocarcinoma of Stomach
HASCHANGE01
Prospective, Single-arm, Single-center Phase II Clinical Study of Perioperative Precision Treatment for Locally Advanced Hepatoid Adenocarcinoma of Stomach
Sponsor study identifier
interventional
30
1 country
1
Study Start
May 20, 2025
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 12, 2025
Actual (reported)May 20, 2025
Actual (reported)May 28, 2025
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
pathological complete response rate
The proportion of subjects with node-negative lymph nodes and without residual viable tumor cells in the total number of subjects
within 10 days after surgery
major pathological response rate
within 10 days after surgery
Objective response rate
From enrollment to surgery, assessed up to 3 months
Event-free survival
From date of enrollment until the date of first documented progression, recurrence or date of death from any cause, whichever came first, assessed up to 3 years
Disease free survival
From date of surgery until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 3 years
overall survival
From date of diagnosis until the date of death from any cause, assessed up to 3 years
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.
RC48+SOX+Sindilizumab
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Peking University Cancer Hospital & Institute
Beijing, China
jiafu ji, MD
Peking University Cancer Hospital & Institute
First Submitted
May 12, 2025
First Posted
May 28, 2025
Study Start
May 20, 2025
Actual (reported)Primary Completion
December 31, 2026
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 22, 2026
Record last verified: 2026-09
De-identified data will be shared after the publication of the results.
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Source: ClinicalTrials.gov.
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