Peking University Cancer Hospital & Institute
Beijing, China
Location status: Recruiting
Recruiting
NCT Number: NCT07178340
Perioperative Therapy for HER2-negative Hepatoid Adenocarcinoma of Stomach
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:
* To evaluate the perioperative efficacy of albumin-bound paclitaxel combined with sintilimab and SOX in the treatment of locally advanced HER2-negative hepatoid adenocarcinoma of stomach * To evaluate the safety and long-term benefits of albumin-bound paclitaxel combined with sintilimab and SOX regimens in perioperative treatment of locally advanced HER2-negative hepatoid adenocarcinoma of stomach
Participants will:
* Preoperative treatment with abumin-bound paclitaxel, SOX and sintilimab for 4 cycles * Radical surgery after 4-6 weeks of the preoperative treatment * Adjuvant treatment with albumin-bound paclitaxel, tegafur,gimeracil and oteracil porassium capsules and sintilimab for 4 cycles
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- The histological type of gastric hepatoid adenocarcinoma was confirmed by pathological biopsy；
- HER2 negative (Immunohistochemistry: 0);
- 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.
Treatment and study plan
Perioperative treatment with albumin-bound paclitaxel, oxaliplatin, tegafur,gimeracil and oteracil porassium capsules and sintilimab.
Drug- 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.
- Radical surgical treatment should be performed within 4-6 weeks after the end of neoadjuvant therapy.
- 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.
Primary outcomes
-
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
Secondary outcomes
-
major pathological response rate
Time frame: Within 10 days after surgery
The proportion of subjects with surviving tumor cells ≤10% in total subjects; Time Frame: 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).
-
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
-
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
-
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Anqiang Wang, MD
CONTACT
Jialin Li, MD
CONTACT
Sponsors and collaborators
Lead sponsor
Peking University Cancer Hospital & Institute
Other
Registry information
Official study title
Prospective, Single-arm, Single-center Phase II Clinical Study of Perioperative Therapy for Locally Advanced HER2-negative Hepatoid Adenocarcinoma of Stomach
Acronym: HASCHANGE02
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Sep 17, 2025
- Registry last updated
- Dec 2, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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