Perioperative Therapy for HER2-negative Hepatoid Adenocarcinoma of Stomach
HASCHANGE02
Prospective, Single-arm, Single-center Phase II Clinical Study of Perioperative Therapy for Locally Advanced HER2-negative Hepatoid Adenocarcinoma of Stomach
Sponsor study identifier
interventional
30
1 country
1
Study Start
September 18, 2025
Actual (reported)Primary Completion
September 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 20, 2028
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 albumin-bound paclitaxel, oxaliplatin, tegafur,gimeracil and oteracil porassium capsules (SOX) and sintilimab works to treat locally advanced HER2-negative 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.
September 20, 2028
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.
September 10, 2025
Actual (reported)September 17, 2025
Actual (reported)September 18, 2025
Actual (reported)September 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 20, 2028
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 for 4 cycles: albumin-bound paclitaxel 150mg/m2, intravenously, d1, a course of treatment every 21 days; sintilimab 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, twice a day, d1-14, every 21 days; oxaliplatin 85mg/m2, intravenously, d1, every 21 days. 2. Radical surgical treatment should be performed within 4-6 weeks after the end of neoadjuvant therapy. 3. Adjuvant therapy for 4 cycles: albumin-bound paclitaxel 125mg/m2, intravenously, d1, a course of treatment every 21 days; sintilimab 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, twice a day, d1-14, every 21 days.
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These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Treatment programme
Perioperative treatment with albumin-bound paclitaxel, oxaliplatin, tegafur,gimeracil and oteracil porassium capsules and sintilimab.
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry recordPeking University Cancer Hospital & Institute
Beijing, China
Jiafu Ji, MD
Peking University Cancer Hospital & Institute
First Submitted
September 10, 2025
First Posted
September 17, 2025
Study Start
September 18, 2025
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
September 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 20, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 2, 2025
Record last verified: 2025-11
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Source: ClinicalTrials.gov.
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