Perioperative Therapy for HER2-negative Hepatoid Adenocarcinoma of Stomach

Phase 2RecruitingNCT07178340

Peking University Cancer Hospital & Institute30 enrolled

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatoid Adenocarcinoma of Stomach

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: within 10 days after surgery

Secondary Outcomes

major pathological response rate

The proportion of subjects with surviving tumor cells ≤10% in total subjects; Time Frame: within 10 days after surgery

Time frame: Within 10 days after surgery

Objective response rate

Proportion of patients who achieved pre-defined tumor volume reduction , including patients with complete response (CR) and partial response (PR).

Time frame: From enrollment to surgery, assessed up to 3 months

Event-free survival

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

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

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

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

It refers to the period from when the patient is diagnosed until death due to any cause.

Time frame: From date of diagnosis until the date of death from any cause, assessed up to 3 years