Clinical trial NCT06992362: Perioperative Treatment of Hepatoid Adenocarcinoma of Stomach
Official title: Prospective, Single-arm, Single-center Phase II Clinical Study of Perioperative Precision Treatment for Locally Advanced Hepatoid Adenocarcinoma of Stomach
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hepatoid Adenocarcinoma of Stomach
Keywords: HER2
SOX
PD-1 inhibitor
Disitamab Vedotin
perioperative treatment
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: perioperative treatment with Disitamab Vedotin，SOX and Sintilimab
Primary purpose: TREATMENT

Brief 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. 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


Eligibility criteria: 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.

Primary outcomes:
measure: pathological complete response rate
timeFrame: within 10 days after surgery
Secondary outcomes:
measure: major pathological response rate
timeFrame: within 10 days after surgery
measure: Objective response rate
timeFrame: From enrollment to surgery, assessed up to 3 months
measure: Event-free survival
timeFrame: 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
measure: Disease free survival
timeFrame: 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
measure: overall survival
timeFrame: From date of diagnosis until the date of death from any cause, assessed up to 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: jiafu ji, MD
role: PRINCIPAL_INVESTIGATOR
References: