Perioperative Therapy for HER2-negative Hepatoid Adenocarcinoma of Stomach

Official title

Prospective, Single-arm, Single-center Phase II Clinical Study of Perioperative Therapy for Locally Advanced HER2-negative Hepatoid Adenocarcinoma of Stomach

Overview

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

Interventions

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

Primary outcome measures

• pathological complete response rate [Time frame: within 10 days after surgery]

Secondary outcome measures (5)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Peking University Cancer Hospital & Institute — Beijing

Identifiers

NCT: NCT07178340 · LGH2025138

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗