Perioperative Treatment of Hepatoid Adenocarcinoma of Stomach (HASCHANGE01)
September 10, 2025 updated by: Peking University Cancer Hospital & Institute
Prospective, Single-arm, Single-center Phase II Clinical Study of Perioperative Precision Treatment for Locally Advanced Hepatoid Adenocarcinoma of Stomach
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Anqiang Wang
- Phone Number: 861088196970
- Email: wanganqiang0902@163.com
Study Contact Backup
- Name: Jialin Li
- Phone Number: 861088196970
- Email: ljldoc@163.com
Study Locations
-
-
-
Beijing, China
- Recruiting
- Peking University Cancer Hospital & Institute
-
Contact:
- Jialin Li, MD
- Phone Number: +861088196970
- Email: ljldoc@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: perioperative treatment for hepatoid adenocarcinoma of stomach
|
RC48+SOX+Sindilizumab
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pathological complete response rate
Time Frame: within 10 days after surgery
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
major pathological response rate
Time Frame: within 10 days after surgery
|
The proportion of subjects with surviving tumor cells ≤10% in total subjects;
|
within 10 days after surgery
|
|
Objective response rate
Time Frame: From enrollment to surgery, assessed up to 3 months
|
Proportion of patients who achieved pre-defined tumor volume reduction , including patients with complete response (CR) and partial response (PR).
|
From enrollment to surgery, assessed up to 3 months
|
|
Event-free survival
Time Frame: 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
|
From the start of treatment to the first occurrence of any of the following events: disease progression without surgical treatment, local or distant recurrence, death from any cause
|
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
Time Frame: 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
|
It usually starts from the time when the patient receives treatment (such as surgery), and ends at the time when the disease recurs (such as tumor recurrence, metastasis) or when the patient dies for any reason
|
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
Time Frame: From date of diagnosis until the date of death from any cause, assessed up to 3 years
|
It refers to the period from when the patient is diagnosed until death due to any cause.
|
From date of diagnosis until the date of death from any cause, assessed up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jiafu Ji, MD, Peking University Cancer Hospital & Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 20, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2029
Study Registration Dates
First Submitted
May 12, 2025
First Submitted That Met QC Criteria
May 24, 2025
First Posted (Actual)
May 28, 2025
Study Record Updates
Last Update Posted (Estimated)
September 16, 2025
Last Update Submitted That Met QC Criteria
September 10, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LGH2024296
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified data will be shared after the publication of the results.
IPD Sharing Time Frame
After the publication
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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