Perioperative Therapy for HER2-negative Hepatoid Adenocarcinoma of Stomach

NCT07178340 | Recruiting Phase 2 DMC

• 1 other identifier: LGH2025138
• 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 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

Conditions

Hepatoid Adenocarcinoma of Stomach

Keywords

HER2; SOX; PD-1 inhibitor; 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

Drug: Perioperative treatment with albumin-bound paclitaxel, oxaliplatin, tegafur,gimeracil and oteracil porassium capsules and sintilimab.

Interventions

Perioperative treatment with albumin-bound paclitaxel, oxaliplatin, tegafur,gimeracil and oteracil porassium capsules and sintilimab. DRUG

1. 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. 2. Radical surgical treatment should be performed within 4-6 weeks after the end of neoadjuvant therapy. 3. 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.

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 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.

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

MeSH Terms

Interventions

Albumin-Bound Paclitaxel; Oxaliplatin; Tegafur; gimeracil; sintilimab

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes; Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jiafu Ji, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anqiang Wang, MD

CONTACT

861088196970; wanganqiang0902@163.com

Jialin Li, MD

CONTACT

861088196970; ljldoc@163.com

Study Design

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

Model Details: perioperative treatment with albumin-bound paclitaxel, oxaliplatin, tegafur,gimeracil and oteracil porassium capsules and sintilimab

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: September 18, 2025
• Primary Completion (Estimated): September 20, 2027
• Study Completion (Estimated): September 20, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

CN (1)