Perioperative Treatment of Hepatoid Adenocarcinoma of Stomach

NCT06992362 | Recruiting Phase 2 DMC

• 1 other identifier: LGH2024296
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatoid Adenocarcinoma of Stomach

Keywords

HER2; SOX; PD-1 inhibitor; Disitamab Vedotin; perioperative treatment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Study Arms (1)

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.

Drug: Perioperative treatment

Interventions

Perioperative treatment DRUG

RC48+SOX+Sindilizumab

perioperative treatment for hepatoid adenocarcinoma of stomach

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, China

RECRUITING

Study Officials

• jiafu ji, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anqiang Wang

CONTACT

861088196970; wanganqiang0902@163.com

Jialin Li

CONTACT

861088196970; ljldoc@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: perioperative treatment with Disitamab Vedotin，SOX and Sintilimab

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 28, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the publication

Locations

CN (1)