Actively Recruiting
Disitamab Vedotin Combined With Tislelizumab and Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Cancer With HER2 Overexpression
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-08-19
40
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The efficacy and safety of combination with Disitamab Vedotin and with Tislelizumab and Capecitabine for perioperative treatment of locally advanced gastric cancer with HER2 overexpression.
CONDITIONS
Official Title
Disitamab Vedotin Combined With Tislelizumab and Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Cancer With HER2 Overexpression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer to take part in the study
- Age between 18 and 75 years, male or female
- Histologically or cytologically confirmed gastric cancer or adenocarcinoma of the gastroesophageal junction
- Clinical stage I or II (cT2-4a, N+, or -, M0) according to AJCC 8th edition
- No prior systemic anti-tumor treatment
- HER2 immunohistochemistry (IHC) test result is 2+ or 3+
- At least one lesion assessable by RECIST 1.1 criteria
- Expected survival time of at least 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Normal function of major organs
You will not qualify if you...
- History of other malignant tumors except those with curative treatment and no disease evidence within 5 years, or successfully treated carcinoma in situ
- Diseases affecting absorption, distribution, metabolism, or clearance of study drugs (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders)
- Previous allogeneic stem cell or solid organ transplantation
- Prior anti-tumor systemic therapy within 4 weeks or unresolved adverse events above CTCAE level 1 (except hair loss and pigmentation)
- Congenital or acquired immunodeficiency
- Active or previous autoimmune or inflammatory diseases requiring treatment, except certain controlled conditions
- Use of systemic immunosuppressive drugs within 2 weeks before enrollment, except limited corticosteroid use
- Allergy to study drugs
- Thrombosis or thromboembolism in past 6 months
- High risk of severe bleeding
- Significant cardiovascular diseases
- Other clinical or laboratory abnormalities affecting safety
- Active serious infections or poorly controlled conditions
- Not recovered from surgery
- Pregnant or lactating women, or unwilling/unable to use effective contraception
- Other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
2
Xuewei Ding
Tianjin, Tianjin Municipality, China, 300308
Actively Recruiting
Research Team
X
Xuewei Ding, Ph.D
CONTACT
H
Han Liang, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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