Hepatoid Adenocarcinoma of StomachPhase 2HASCHANGE01NCT06992362
Perioperative Treatment of Hepatoid Adenocarcinoma of Stomach
A Phase 2 study testing Perioperative treatment in people with Hepatoid Adenocarcinoma of Stomach, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatoid Adenocarcinoma of Stomach
- What is being tested?
- Perioperative treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2025to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital & Institute
Beijing
Jialin Li, MD, +861088196970, ljldoc@163.com
About this study
Official title: 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
Read more
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
- Conditions
- Hepatoid Adenocarcinoma of Stomach
- Being tested
- Perioperative treatment
- Keywords
- HER2, SOX, PD-1 inhibitor, Disitamab Vedotin, perioperative treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative treatmentDrug
RC48+SOX+Sindilizumab
| Study group | Role | What they receive |
|---|---|---|
| perioperative treatment for hepatoid adenocarcinoma of stomach | Experimental | 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. Receives: Drug: Perioperative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 10 days after surgery
Secondary outcomes (5)
major pathological response rate
The proportion of subjects with surviving tumor cells ≤10% in total subjects;
Measured: within 10 days after surgery
Objective response rate
Proportion of patients who achieved pre-defined tumor volume reduction , including patients with complete response (CR) and partial response (PR).
Measured: From enrollment to surgery, assessed up to 3 months
Event-free survival
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
Measured: 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
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
Measured: 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
It refers to the period from when the patient is diagnosed until death due to any cause.
Measured: From date of diagnosis until the date of death from any cause, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start20 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatoid Adenocarcinoma of StomachStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- perioperative treatment with Disitamab Vedotin，SOX and Sintilimab
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jiafu ji, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992362
- Sponsor's protocol ID
- LGH2024296
- Acronym
- HASCHANGE01
- Status last verified
- Sep 2026
- First submitted
- 12 May 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared after the publication of the results.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-arm, Single-center Phase II Clinical Study of Perioperative Precision Treatment for Locally Advanced Hepatoid Adenocarcinoma of Stomach
- ClinicalTrials.gov ID
- NCT06992362
- Acronym / sponsor ID
- HASCHANGE01 / LGH2024296
- Conditions
- Hepatoid Adenocarcinoma of Stomach
- Keywords
- HER2, SOX, PD-1 inhibitor, Disitamab Vedotin, perioperative treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- perioperative treatment with Disitamab Vedotin，SOX and Sintilimab
| Arm | Type | Receives |
|---|---|---|
| perioperative treatment for hepatoid adenocarcinoma of stomach | Experimental | Drug: Perioperative treatment1. 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perioperative treatmentRC48+SOX+Sindilizumab | Drug | perioperative treatment for hepatoid adenocarcinoma of stomach |
Primary outcome
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
5 secondary outcomes
major pathological response rate
Time frame: within 10 days after surgery
Objective response rate
Time frame: 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
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
overall survival
Time frame: From date of diagnosis until the date of death from any cause, assessed up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be shared after the publication of the results.
Related trials for Hepatoid Adenocarcinoma of Stomach
RecruitingPhase 2
Perioperative Therapy for HER2-negative Hepatoid Adenocarcinoma of Stomach
Hepatoid Adenocarcinoma of Stomach
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
jiafu ji, MD principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Perioperative treatment in people with Hepatoid Adenocarcinoma of Stomach, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anqiang Wang (861088196970, wanganqiang0902@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete response rate (time frame: within 10 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.