Actively Recruiting
Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma.
Led by RemeGen Co., Ltd. · Updated on 2023-12-14
90
Participants Needed
11
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of perioperative Disitamab Vedotin plus Toripalimab and XELOX versus Disitamab Vedotin plus Toripalimab versus XELOX in subjects with HER2-expressing resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.
CONDITIONS
Official Title
Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Male or female aged 18 years or older
- Histopathologically confirmed gastric or gastroesophageal junction adenocarcinoma
- Clinical stage cT3-4aN+ with no distant metastasis (M0)
- Expected to undergo radical surgery with R0 resection based on medical evaluation
- No prior antitumor therapy for gastric or gastroesophageal junction adenocarcinoma
- HER2 expression levels of IHC 1+, 2+, or 3+
- ECOG performance status score of 0 or 1
- Left ventricular ejection fraction of 50% or higher
- Adequate bone marrow, liver, kidney, and coagulation function within 7 days prior to dosing
- Female participants must be surgically sterilized, postmenopausal, or use effective contraception before and after treatment and not be breastfeeding
- Male participants must agree to use contraception before and after treatment
- Able to understand and follow trial and follow-up procedures
You will not qualify if you...
- Prior anti-tumor therapy for gastric or gastroesophageal junction adenocarcinoma before dosing
- Need for perioperative radiotherapy for target lesions
- Major surgery within 4 weeks before dosing without full recovery
- Active gastrointestinal bleeding or high bleeding risk within 2 weeks prior to screening
- Gastrointestinal perforation or fistula within 6 months before screening
- Upper digestive tract obstruction affecting drug absorption
- Peripheral polyneuropathy grade 2 or higher
- Positive tests for active hepatitis B, hepatitis C, or HIV infections
- Received live vaccine within 4 weeks prior to screening or planned vaccination during study (except COVID-19 vaccine)
- Heart failure NYHA class 3 or higher
- Recent serious cardiac events or chest pain restricting daily activities
- Active or advanced infections requiring systemic treatment
- Unstable systemic diseases such as diabetes, hypertension, or cirrhosis
- Lung diseases requiring treatment that could interfere with surgery
- Active autoimmune diseases requiring systemic therapy within 2 years
- Use of systemic steroids or immunosuppressants within 14 days prior to screening
- Other malignancies within 5 years except certain treated cancers
- History of allogeneic stem cell or organ transplantation
- Allergies to study drugs
- Known dipyrimidine dehydrogenase deficiency
- Use of immunotherapy or investigational drugs within 28 days prior to screening
- Pregnant or breastfeeding women
- Any other condition making participation unsafe or unsuitable as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100042
Actively Recruiting
2
Fujian Cancer Hospital
Fuzhou, Fujian, China
Not Yet Recruiting
3
Yunnan Cancer Hospital
Kunming, Fujian, China
Not Yet Recruiting
4
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Not Yet Recruiting
5
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, China
Not Yet Recruiting
6
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Not Yet Recruiting
7
Nanfang Hospital
Guangzhou, Guangdong, China
Not Yet Recruiting
8
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Not Yet Recruiting
9
Henan Cancer Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
10
Shandong Cancer Hospital & Institute
Jinan, Shangdong, China
Not Yet Recruiting
11
Sichuan Cancer Hospital & Institute
Chengdu, Sichuan, China
Not Yet Recruiting
Research Team
J
Jianmin Fang, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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